A Phase 1 interventional study of Insulin human and Octreotide Acetate in Insulin Resistance, Prediabetic State and Hyperinsulinemia, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-12.
Sponsored by Columbia University · Phase 1, Interventional, and Basic science
This is a single-center, prospective, randomized, controlled (crossover) clinical study designed to investigate the specific dose-response impact of insulin infusion rate (IIR) on blood glucose levels during a pancreatic clamp study. The investigators will recruit participants with a history of overweight/obesity and evidence of insulin resistance (i.e., fasting hyperinsulinemia plus prediabetes and/or impaired fasting glucose and/or Homeostasis Model Assessment of Insulin Resistance [HOMA-IR] score >=2.73), and with evidence of, or clinically judged to be at high risk for, uncomplicated non-alcoholic fatty liver disease (NAFLD). Participants will undergo two pancreatic clamp procedures in which individualized basal IIR are identified, followed in one by maintenance of basal IIR (maintenance hyperinsulinemia, MH) and in the other by a stepped decline in IIR (reduction toward euinsulinemia, RE). In both clamps the investigators will closely monitor plasma glucose and various metabolic parameters. The primary outcome will be the absolute and relative changes in steady-state plasma glucose levels at each stepped decline in IIR.
Although high blood sugar and risk of heart disease are the most well-known health effects of type 2 diabetes (T2DM), nonalcoholic fatty liver disease (NAFLD), in which too much fat accumulates in the liver, has come to be recognized as another important complication. Unchecked, NAFLD can progress to severe liver inflammation, liver failure, and even liver cancer. The investigators suspect that high levels of the blood sugar-lowering hormone insulin leads to excessive fat production by the liver, and so lowering insulin levels might help to improve NAFLD. In order to answer this question, the investigators will recruit people at risk for T2DM and NAFLD to perform a "pancreatic clamp" - a procedure in which the body's production of insulin is temporarily shut off and then replaced at the same or lower levels. Again, the investigators expect that lowering insulin levels will lower fat production. Because this is a new research approach, the investigators first need to understand how lowering insulin levels affects blood sugar. Research participants in this pilot study will therefore undergo two pancreatic clamps in random order: one roughly maintaining their own internal ("basal") insulin level and one in which the investigators lower that basal insulin level by up to 50%. In each case, the investigators will observe the absolute and relative changes in blood sugar and the levels of certain fats as the investigators change the insulin level. Once the investigators have found a lower insulin level that they can safely maintain, the investigators will go on to study its effect on fat production in a later study.
2,969 studies on the registry are indexed under Insulin Resistance; 338 are open to participants now.
This study's enrollment of 18 is below the median of 40 across 2,369 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Evidence of insulin resistance, represented by any or all of the following criteria:
a. Meeting either of the American Diabetes Association's definitions for prediabetes or IFG within the previous year* and on screening labs: i. Prediabetes: 5.7-6.4% ii. IFG: plasma glucose of 100-125 mg dL-1 after 8-h fast b. Homeostasis Model of Insulin Resistance (HOMA-IR) score ≥ 2.73
Exclusion Criteria:
Concerns arising at screening visit (any of the following):
i. Unwillingness to use only bedpan or urinal to void during the clamp
ii. Unwillingness to fast (except water) for up to 22 hours
iii. Documented weight loss of ≥ 5% of baseline within the previous 6 months
iv. Abnormal blood pressure (including on treatment, if prescribed)
Diastolic blood pressure \< 60 mm Hg or > 100 mm Hg
v. Abnormal resting heart rate: \<60 or ≥100 bpm
vi. Abnormal screening (or if on file, performed within previous 90 d)
vii. Laboratory evidence of diabetes mellitus:
viii. Positive qualitative β-hCG (i.e., pregnancy test) in women of
ix. Liver function abnormalities (either of the following) - Transaminases ( or ALT) > 3.0 x the - Total > 1.25 x the upper limit of normal
x. Abnormal fasting triglycerides at screening ≥ 400 mg/dL
xi. Abnormal screening serum electrolytes (any of the following)
xii. Abnormal complete blood count (CBC) (any of the following)
Reproductive concerns i. Women of childbearing potential not using highly effective , defined as:
ii. Women currently pregnant, measured by serum and/or urine human chorionic gonadotropin, beta subunit (β-hCG)
iii. Women currently breastfeeding
Concerns related to lipid metabolism i. Known diagnoses of familial hypercholesterolemia, familial combined hyperlipidemia, or familial hyperchylomicronemia in the participant or a first-degree relative ii. Use of certain lipid-lowering drugs other than statins for primary prevention within 90 d prior to screening visit, including: • Statins or PCSK9 inhibitors for secondary prevention or treatment of familial hypercholesterolemia. Statins or PCSK9 inhibitors for primary prevention of ASCVD are acceptable.
Known, documented history, at the time of screening, of any of the following medical conditions:
i. Pancreatic pathology ii. Significant cardiovascular diseases (N.B. uncomplicated hypertension is not exclusionary) iii. Chronic kidney disease, Stage 3 or higher (estimated glomerular filtration rate \< 60 mL / min / 1.73 m2), of any cause iv. Advanced or severe liver disease v. Gallstone disease vi. Chronic viral illness including (HIV), virus (HBV), or virus (HCV) (N.B. diagnosis based only on medical history; we will not test for any of these viruses at any point in this study) vii. Active malabsorptive conditions viii. Active seizure disorder (including controlled with antiepileptic drugs) ix. Psychiatric diseases causing functional impairment that have been decompensated within 1 year or require use of drugs associated with significant weight gain/metabolic dysfunction x. Other endocrinopathies (e.g., Cushing syndrome, adrenal insufficiency) xi. Venous thromboembolic disease (deep vein thrombosis or pulmonary embolism) or any required use of therapeutic anticoagulation xii. Bleeding disorders, including due to anticoagulation, or significant anemia (see above) xiii. Dysautonomia, including post-vagotomy xiv. Active , or hormonally active benign neoplasm, except for non-melanoma skin cancer or differentiated thyroid cancer (AJCC Stage I only)
Use of certain medications currently or within 90 d prior to screening:
i. Prescribed medications used for any of the indications in the preceding list of excluded conditions, or their use within 90 d prior to screening, except allowances for:
•• Note, as above, that antidiabetic drugs except metformin for any indication within 90 d of screening are excluded ii. Oral or parenteral (at greater than prednisone 5 mg daily, or equivalent) for more than 3 days within the previous 90 days; topical and inhaled formulations are permitted iii. Fludrocortisone iv. Opioids other than dextromethorphan for cough
History of certain weight-loss (bariatric) surgery, including:
i. Roux-en-Y gastric bypass ii. Biliopancreatic diversion iii. Restrictive procedures (lap band, sleeve gastrectomy) performed within the past 6 months
Positive urine drug screen, with exceptions for:
i. Lawfully prescribed medications ii. Marijuana/THC positivity, provided that the participant agrees not to use it during the same period that they will abstain from alcohol
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The basal insulin infusion rate (IIR) necessary to maintain participants' mean basal fasting plasma glucose (mbFPG) will be determined during the basal titration period. Then, during the intervention period, the IIR will remain at 100% of basal for the full duration (225 min). The IIR and resulting insulin levels are expected to be relatively high (cf. hyperinsulinemia) because of underlying insulin resistance.
Drug: Insulin human · Drug: Octreotide Acetate · Drug: Glucagon · Drug: Growth Hormone, Human · Other: [6,6-2H2] D-glucose · Drug: 20% D-glucose (aq) · Dietary Supplement: BOOST Plus · Dietary Supplement: CORE Bar · Device: Harvard Apparatus PHD ULTRA CP syringe pump · Device: Yellow Springs Instruments (YSI) 2500 Biochemistry Glucose/Lactate Analyzer
The basal insulin infusion rate (IIR) necessary to maintain participants' mean basal fasting plasma glucose (mbFPG) will be determined during the basal titration period. Then, during the intervention period, the basal IIR will be reduced by up to 50%. Thus, the basal hyperinsulinemia expected due to underlying insulin resistance will be reduced toward euinsulinemia.
Drug: Insulin human · Drug: Octreotide Acetate · Drug: Glucagon · Drug: Growth Hormone, Human · Other: [6,6-2H2] D-glucose · Drug: 20% D-glucose (aq) · Dietary Supplement: BOOST Plus · Dietary Supplement: CORE Bar · Device: Harvard Apparatus PHD ULTRA CP syringe pump · Device: Yellow Springs Instruments (YSI) 2500 Biochemistry Glucose/Lactate Analyzer
Insulin infusion rate (IIR) will be determined empirically first to maintain mean basal fasting plasma glucose, and then either maintained at the basal rate (MH protocol) or be reduced stepwise toward euinsulinemia (RE protocol).
Octreotide will be infused at 30 ng/kg/min to suppress endogenous insulin, glucagon, and growth hormone secretion. Co-administered with glucagon and rhGH.
Glucagon will be replaced at a constant rate of up to 0.65 ng/kg/min to maintain baseline counterregulatory response. Co-administered with octreotide and rhGH.
Recombinant human growth hormone (rhGH) will be replaced at a constant rate of up to 3 ng/kg/min to maintain baseline counterregulatory response. Co-administered with octreotide and glucagon.
Stable isotope tracer administered to calculate glucose kinetics during pancreatic clamp.
Also known as: D2-glucose, D2G
20% D-glucose (aq) (D20W) will be administered to counteract hypoglycemia or strongly downward blood glucose trends, as needed.
Also known as: D20W
Nutritional supplement will be administered to provide three standardized "mixed meals" on the day before the pancreatic clamp.
Energy bar used as a standardized snack on the day before the pancreatic clamp.
Syringe pump used for highly precise administration of insulin, octreotide/glucagon/rhGH, and D20W (as needed) even at low infusion rates.
Glucose oxidase analyzer used to detect plasma glucose levels at the point of care. YSI have been the gold standard in clamp studies for many years. Two machines will run in parallel to ensure accuracy of results.
Plasma glucose (absolute values) (units: mg/dL)
Goal is first to clamp insulin infusion rate to maintain mean basal fasting plasma glucose during the basal titration phase, and then during the intervention phase to observe the glucose levels that result from altering the basal IIR.
Time frame: Up to 425 minutes from the start of the procedure.
Plasma glucose (relative/change) (units: fold difference and/or ∆mg/dL relative to previous time points)
Goal is first to clamp insulin infusion rate to maintain mean basal fasting plasma glucose during the basal titration phase, and then during the intervention phase to observe the impact of altering the basal IIR on glycemia.
Time frame: Up to 425 minutes from the start of the procedure.
Serum insulin (absolute values) (units: micro-international units per milliliter (µIU/mL))
Investigators will assess the insulin levels attained at the basal IIR, and at each stepwise reduction in IIR during the intervention phase.
Time frame: Up to 425 minutes from the start of the procedure.
Serum insulin (relative/change) (units: fold difference and/or ∆ µIU/mL relative to previous time points)
Investigators will compare the baseline insulin level to that attained at the basal IIR, as well as comparing to the change in insulin level that occurs with alterations in the IIR during the intervention phase.
Time frame: Up to 425 minutes from the start of the procedure.
Serum C-peptide (absolute values) (units: ng/mL)
Suppression of endogenous insulin by octreotide during pancreatic clamp is expected to result in a fall in C-peptide levels to near zero.
Time frame: Up to 425 minutes from the start of the procedure
Serum C-peptide (relative/change) (units: fold difference and/or ∆ µIU/mL relative to previous time points)
Suppression of endogenous insulin by octreotide during pancreatic clamp is expected to result in a fall in C-peptide levels to near zero.
Time frame: Up to 425 minutes from the start of the procedure
Serum or plasma triglyceride (TG) (absolute values) (units: mg/dL)
TG levels in serum reflect hepatic synthesis/storage and very low-density lipoprotein (VLDL) secretion.
Time frame: Up to 425 minutes from the start of the procedure
Serum or plasma triglyceride (TG) (relative/change) (units: fold difference and/or ∆mg/dL relative to previous time points)
TG levels in serum reflect hepatic synthesis/storage and VLDL secretion.
Time frame: Up to 425 minutes from the start of the procedure
Serum or plasma free fatty acid (FFA) (absolute values) (units: mg/dL)
FFA levels reflect adipose tissue lipolysis and its response to insulin and counterregulatory hormones.
Time frame: Up to 425 minutes from the start of the procedure
Serum or plasma free fatty acid (FFA) (relative/change) (units: fold difference and/or ∆mg/dL relative to previous time points)
FFA levels reflect adipose tissue lipolysis and its response to insulin and counterregulatory hormones.
Time frame: Up to 425 minutes from the start of the procedure
Serum or plasma apolipoprotein B (ApoB) (absolute values) (units: mg/dL)
ApoB level is a surrogate for triglyceride-rich lipoproteins, especially hepatic VLDL.
Time frame: Up to 425 minutes from the start of the procedure
Serum or plasma apolipoprotein B (ApoB) (relative/change) (units: fold difference and/or ∆mg/dL relative to previous time points)
ApoB level is a surrogate for triglyceride-rich lipoproteins, especially hepatic VLDL.
Time frame: Up to 425 minutes from the start of the procedure
Plasma glucose kinetics: rate of appearance (units: mg/kg/min)
Calculated from D2G tracer enrichment by the Steele equations.
Time frame: Measured every 5 minutes x 4 at the end of each steady-state IIR period, up to 425 minutes from the start of the procedure
Plasma glucose kinetics: rate of disappearance (units: mg/kg/min)
Calculated from D2G tracer enrichment by the Steele equations
Time frame: Measured every 5 minutes x 4 at the end of each steady-state IIR period, up to 425 minutes from the start of the procedure
Plasma glucose kinetics: endogenous glucose production (units: mg/kg/min)
Calculated from D2G tracer enrichment by the Steele equations
Time frame: Measured every 5 minutes x 4 at the end of each steady-state IIR period, up to 425 minutes from the start of the procedure
Serum/plasma glucagon (absolute values) (units: ng/L)
Assesses the adequacy of exogenous glucagon replacement.
Time frame: Up to 425 minutes from the start of the procedure
Serum or plasma glucagon (relative/change) (units: fold difference and/or ∆ng/L relative to previous time points)
Assesses the adequacy of exogenous glucagon replacement.
Time frame: Up to 425 minutes from the start of the procedure
Serum or plasma growth hormone (absolute values) (units: ng/mL)
Assesses the adequacy of exogenous rhGH replacement.
Time frame: Up to 425 minutes from the start of the procedure
Serum or plasma growth hormone (relative/change) (units: fold difference and/or ∆ng/mL relative to previous time points)
Assesses the adequacy of exogenous rhGH replacement.
Time frame: Up to 425 minutes from the start of the procedure
Plan to share: Yes — Blood samples will be banked in our Insulin Resistance Biobank and will be made available to other researchers for legitimate research purposes upon request. Associated data will be shared along with specimens in the smallest possible quantity and on a need-to-know basis. No Protected Health Information (PHI) will ever be disclosed to other researchers. All requests will be reviewed by the PI for scientific merit and samples/data will be transferred only upon completion of an Institutional Review Board-approved Material Transfer Agreement (MTA) and/or Data Use Agreement (DUA), as appropriate.
Supporting information: Study protocol
Time frame: Indefinitely following study completion.
Access criteria: All requests will be reviewed by the PI for scientific merit and samples/data will be transferred only upon completion of a MTA or DUA, as appropriate. No PHI will be disclosed or shared.
No publications or documents are linked to this record.
Ran from Aug 2023 to primary completion in Sep 2025, 24 months.
Of 51 non-industry phase 1 interventional studies under Insulin Resistance, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 80. This study's 24 months is close to that.
Counting every sponsor, half of 65 studies reached it within 24 months; a quarter within 13 and three quarters within 67.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Insulin, Regular, Human · Octreotide · Glucagon · Human Growth Hormone · Glucose