An interventional study of insulin infusion and Dextrose infusion in Insulin Resistance, sponsored by University at Buffalo. Completed at 1 site in United States. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by University at Buffalo · Not applicable, Interventional, and Treatment
This study will help us understand the possible beneficial effects of insulin in inflammation. Inflamamtion is considered to be the cause of atherosclerosis and heart disease.
Obesity and type 2 diabetes are major health problems in the United States and the world. Both conditions are characterized by increased inflammation and oxidative stress and are associated with increased risk of cardiovascular disease.
Our previous work shows that insulin exerts a prompt and powerful anti-inflammatory effect, on circulating blood cells and in plasma in healthy subjects and in critically ill patients.
Toll like receptors (TLRs) recognize bacterial and viral products like endotoxin and viruses and are major determinants of the inflammatory response against foreign pathogens. In view of the recent data showing that TLRs recognize a range of molecules and proteins that are not of pathogenic source like saturated lipids and that TLRs are involved in the pathogenesis of atherosclerosis which leads to cardiovascular disease and insulin resistance which leads to type 2 diabetes (DM) we hypothesized that insulin infusion suppresses TLRs expression.
Our preliminary data show that insulin infusion for 4 hours reduces the levels of many TLRs and thus might protect from inflammation induced conditions We therefore propose to investigate, in more detail, the effect of infusing different doses of insulin on TLRs mRNA and protein levels and its activity in obese and DM subjects over a longer infusion period and a larger number of subjects in circulating white blood cells and in fat tissue. Also we will be comparing the baseline levels of TLRs and TLRs related proteins as well as their modulation by insulin between normal, obese and DM subjects.
2,969 studies on the registry are indexed under Insulin Resistance; 338 are open to participants now.
This study's enrollment of 42 is close to the median of 40 across 2,369 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →University at Buffalo is the lead sponsor of 76 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) 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.
Lean Group:
Obese Group:
DM Group:
EXCLUSION CRITERIA
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.
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.
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.
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.
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).
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.
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.
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.
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.
obese (BMI \>30Kg/m2) subjects infused with insulin, dextrose and saline in this specific sequence 1 week apart. Each infusion will continue for up to 24 hr
Drug: insulin infusion · Drug: Dextrose infusion · Drug: Saline Infusion
Normal weight subjects infused with insulin, dextrose and saline in this specific sequence 1 week apart. Each infusion will continue for up to 24 hr
Drug: insulin infusion · Drug: Dextrose infusion · Drug: Saline Infusion
obese (BMI \>30Kg/m2) subjects with type 2 diabetes infused with insulin, dextrose and saline in this specific sequence 1 week apart. Each infusion will continue for up to 24 hr
Drug: insulin infusion · Drug: Dextrose infusion · Drug: Saline Infusion
insulin to be infused at 3.5 units/hour along with Dextrose 12.5% at a rate to achieve blood glucose levels between 80-120mg/dl
Also known as: Intravenous regular insulin infusion
Dextrose 12.5% will be infused at a rate to maintain blood glucose level 80-120mg/dl
Also known as: Intravenous dextrose solution infusion
Saline will be infused at 100ml/hr
Also known as: normal saline infusion
Suppression of Toll Like Receptor (TLR) 2 mRNA by Insulin
percent change from baseline (0hrs) in TLR2 mRNA in mononuclear cells (MNC) following up to 24 hrs of 3.5U/hr insulin infusion (II) adjusted to the similar average change following up to 24hr infusion of dextrose (DI) and saline (SI) control groups. The correction is calculated as follows: Corrected percent change from baseline following II= change from baseline following II - (average change from baseline following DI and SI)\*100. Changes from baseline are calculated as: (expression at 24hrs-expression at 0hr)/expression at 0hr.
Time frame: 24 hours
Change in TLR4 mRNA in MNC
percent change from baseline (0hrs) in TLR4 mRNA in mononuclear cells (MNC) following up to 24 hrs of 3.5U/hr insulin infusion (II) adjusted to the same change following up to 24hr infusion of dextrose (DI) and saline (SI) control groups in this order. The correction is conducted as follows: Corrected percent change from baseline following II= change from baseline following II - (average change from baseline following DI and SI)\*100. Changes from baseline are calculated as: (expression at 24hrs-expression at 0hr)/expression at 0hr. 2- For each PCR measurement of specific target gene, relative expression of 3 housekeeping genes (beta-actin, ubiquitin C and cyclophilin A) from the same cDNA is assessed, and normalization factor (based on the 3 genes) is calculated and entered into PCR software to automatically adjust/normalize target gene expression
Time frame: 24 hours
Change in CD14 Expression in MNC
percent change from baseline (0hrs) in CD14 mRNA in mononuclear cells (MNC) following up to 24 hrs of 3.5U/hr insulin infusion (II) adjusted to the similar average change following up to 24hr infusion of dextrose (DI) and saline (SI) control groups in this specific order. The correction is conducted as follows: Corrected percent change from baseline following II= change from baseline following II - (average change from baseline following DI and SI)\*100. Changes from baseline are calculated as: (expression at 24hrs-expression at 0hr)/expression at 0hr. For each PCR measurement of specific target gene, relative expression of 3 housekeeping genes (beta-actin, ubiquitin C and cyclophilin A) from the same cDNA is assessed, and normalization factor (based on the 3 genes) is calculated and entered into PCR software to automatically adjust/normalize target gene expression.
Time frame: 24hrs
Fasting TLR2 mRNA Expression Levels in the 3 Cohorts
Comparison of TLR2 mRNA expression in MNC in fasting condition. Fasting TLR2 mRNA expression is measured using real-time PCR at baselines of the 3 visits (II, DI, SI visits) is averaged and reported as arbitrary units. For each PCR measurement of specific target gene, relative expression of 3 housekeeping genes (beta-actin, ubiquitin C and cyclophilin A) from the same cDNA is assessed, and normalization factor (based on the 3 genes) is calculated and entered into PCR software to automatically adjust/normalize target gene expression.
Time frame: baseline/fasting
| Milestone | Obese Subjects | Normal Weight Subjects | Obese Type 2 Diabetes Subjects |
|---|---|---|---|
| Started | 13 | 10 | 19 |
| Completed insulin infusion | 13 | 10 | 19 |
| Completes dextrose infusion | 13 | 10 | 19 |
| Completed saline infusion | 13 | 10 | 17 |
| Completed | 13 | 10 | 19 |
| Not completed | 0 | 0 | 0 |
percent change from baseline (0hrs) in TLR2 mRNA in mononuclear cells (MNC) following up to 24 hrs of 3.5U/hr insulin infusion (II) adjusted to the similar average change following up to 24hr infusion of dextrose (DI) and saline (SI) control groups. The correction is calculated as follows: Corrected percent change from baseline following II= change from baseline following II - (average change from baseline following DI and SI)\*100. Changes from baseline are calculated as: (expression at 24hrs-expression at 0hr)/expression at 0hr.
| percentage of change | Obese Subjects | Normal Weight Subjects | Obese Type 2 Diabetes Subjects |
|---|---|---|---|
| Suppression of Toll Like Receptor (TLR) 2 mRNA by Insulin | -24 ± 8 | -17 ± 4 | -29 ± 7 |
percent change from baseline (0hrs) in TLR4 mRNA in mononuclear cells (MNC) following up to 24 hrs of 3.5U/hr insulin infusion (II) adjusted to the same change following up to 24hr infusion of dextrose (DI) and saline (SI) control groups in this order. The correction is conducted as follows: Corrected percent change from baseline following II= change from baseline following II - (average change from baseline following DI and SI)\*100. Changes from baseline are calculated as: (expression at 24hrs-expression at 0hr)/expression at 0hr. 2- For each PCR measurement of specific target gene, relative expression of 3 housekeeping genes (beta-actin, ubiquitin C and cyclophilin A) from the same cDNA is assessed, and normalization factor (based on the 3 genes) is calculated and entered into PCR software to automatically adjust/normalize target gene expression
| percentage of change | Obese Subjects | Normal Weight Subjects | Obese Type 2 Diabetes Subjects |
|---|---|---|---|
| Change in TLR4 mRNA in MNC | -36 ± 11 | -24 ± 9 | -30 ± 9 |
percent change from baseline (0hrs) in CD14 mRNA in mononuclear cells (MNC) following up to 24 hrs of 3.5U/hr insulin infusion (II) adjusted to the similar average change following up to 24hr infusion of dextrose (DI) and saline (SI) control groups in this specific order. The correction is conducted as follows: Corrected percent change from baseline following II= change from baseline following II - (average change from baseline following DI and SI)\*100. Changes from baseline are calculated as: (expression at 24hrs-expression at 0hr)/expression at 0hr. For each PCR measurement of specific target gene, relative expression of 3 housekeeping genes (beta-actin, ubiquitin C and cyclophilin A) from the same cDNA is assessed, and normalization factor (based on the 3 genes) is calculated and entered into PCR software to automatically adjust/normalize target gene expression.
| percentage of change | Obese Subjects | Normal Weight Subjects | Obese Type 2 Diabetes Subjects |
|---|---|---|---|
| Change in CD14 Expression in MNC | -41 ± 12 | -22 ± 8 | -32 ± 10 |
Comparison of TLR2 mRNA expression in MNC in fasting condition. Fasting TLR2 mRNA expression is measured using real-time PCR at baselines of the 3 visits (II, DI, SI visits) is averaged and reported as arbitrary units. For each PCR measurement of specific target gene, relative expression of 3 housekeeping genes (beta-actin, ubiquitin C and cyclophilin A) from the same cDNA is assessed, and normalization factor (based on the 3 genes) is calculated and entered into PCR software to automatically adjust/normalize target gene expression.
| Arbitrary units | Obese Subjects | Normal Weight Subjects | Obese Type 2 Diabetes Subjects |
|---|---|---|---|
| Fasting TLR2 mRNA Expression Levels in the 3 Cohorts | 1.21 ± 0.28 | .95 ± .21 | 1.42 ± 0.27 |
Collected over Adverse events were collected for the duration of the infusion plus 2 hr after completion of infusion for a total of up 26 hrs. Adverse events are collected, combined and reported as per participant during all of the 3 interventions (3 separate infusions). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Obese Subjects | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Normal Weight Subjects | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Obese Type 2 Diabetes Subjects | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
Each patient in each of the 3 cohorts was infused with insulin, dextrose and saline in this specific sequence 1 week apart. Therefore, for each cohort baseline measures are reported only once (at the time of insulin infusion).
| Age, Continuous(YEARS) | Obese Subjects | Normal Weight Subjects | Obese Type 2 Diabetes Subjects | Total |
|---|---|---|---|---|
| Mean | 48 ± 10 | 50 ± 17 | 50 ± 13 | 50 ± 12 |
| Sex: Female, Male(Participants) | Obese Subjects | Normal Weight Subjects | Obese Type 2 Diabetes Subjects | Total |
|---|---|---|---|---|
| Female | 6 | 3 | 5 | 14 |
| Male | 7 | 7 | 14 | 28 |
| Body Mass Index (BMI)(Kg/m^2) | Obese Subjects | Normal Weight Subjects | Obese Type 2 Diabetes Subjects | Total |
|---|---|---|---|---|
| Mean | 38.9 ± 11.0 | 23.9 ± 1.5 | 38.2 ± 9.2 | 35.0 ± 9.1 |
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Insulin
University at Buffalo