A Phase 4 interventional study of Insulin resistance testing and OGTT in Diabetes Mellitus, Type 2, Diabetes and Type 2 Diabetes, sponsored by Stanford University. Recruiting at 2 sites in United States. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by Stanford University · Phase 4, Interventional, and Treatment
This study is to investigate how adipocyte (fat cell) function and fat distribution differ between individuals with normal-weight type 2 diabetes (NWD), those with overweight type 2 diabetes (OWD), and normal-weight controls without diabetes (NWC). The study will assess whether adipocyte-directed therapies, specifically pioglitazone and tirzepatide, can improve insulin resistance, adipocyte function, and fat distribution in individuals with NWD. By analyzing the biological mechanisms underlying adipocyte dysfunction, the study aims to provide insights into novel treatment strategies for improving metabolic health in normal-weight individuals with type 2 diabetes.
The investigators aim to learn how adipocyte dysfunction and disordered fat distribution contribute to the development of type 2 diabetes in normal-weight individuals. The investigators hope to determine whether adipocyte-directed therapies, such as pioglitazone and tirzepatide, can improve insulin sensitivity, fat distribution, and metabolic health in this population. This study is important because most diabetes research focuses on overweight or obese individuals, and very little is known about how diabetes affects those with normal body weight. Understanding the unique biology of normal-weight diabetes could lead to more personalized and effective treatment strategies, filling a gap in diabetes care for a group that can be overlooked in clinical research.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 104 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) 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.
Normal-Weight Diabetes (NWD) Group:
Normal-Weight Control (NWC) Group:
Exclusion Criteria:
Substance Abuse: Participants with a history of substance abuse are excluded for similar reasons.
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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.
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.
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.
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.
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.
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.
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.
Control
Procedure: Insulin resistance testing · Procedure: OGTT · Procedure: Fat biopsy · Radiation: DXA scan · Procedure: MRI · Procedure: 1H-MRS
Baseline testing Intervention with tirzepatide for 16 weeks Retesting Washout for 5 weeks Intervention with pioglitazone for 16 weeks Retesting
Procedure: Insulin resistance testing · Procedure: OGTT · Procedure: Fat biopsy · Radiation: DXA scan · Procedure: MRI · Procedure: 1H-MRS · Drug: Tirzepatide · Drug: Pioglitazone
Baseline testing Intervention with pioglitazone for 16 weeks Retesting Washout for 5 weeks Intervention with tirzepatide for 16 weeks Retesting
Procedure: Insulin resistance testing · Procedure: OGTT · Procedure: Fat biopsy · Radiation: DXA scan · Procedure: MRI · Procedure: 1H-MRS · Drug: Tirzepatide · Drug: Pioglitazone
Steady state Plasma Glucose test
Also known as: SSPG
Will collect 5 blood draws during the test to measure insulin secretion
Also known as: Oral glucose tolerance test
Needle biopsy to gather a sample of abdominal subcutaneous fat
Whole body DXA scan
Abdominal MRI
Spectroscopy of the abdominal region
Also known as: proton magnetic resonance spectroscopy
16 weeks started at 2.5mg/week and increased to 5mg/week dose
Also known as: Mounjaro
16 weeks at a 45mg/day dose
Also known as: Actos
Insulin resistance in normal weight women with diabetes compared to those with no diabetes
Insulin resistance will be measured by a Steady State Plasma Glucose test (SSPG). Results will be measured by glucose levels at steady state in mg/dL.
Time frame: Baseline measures comparison between the groups
Adipocyte function in women with normal weight diabetes as compared with those without diabetes
Adipocyte function will be measured as percent small adipocytes and peak diameter adipocytes from the fat biopsies.
Time frame: Baseline comparisons
Fat storage in women with normal weight diabetes compared to those without diabetes
Fat storage will be measured by MRI. Quantification of subcutaneous and visceral abdominal fat will be obtained by MRI using a fat-water imaging sequence (parameters: IDEAL-IQ: 3D GRE, 160x160 matrix, 6 echoes, 4 degree flip angle, minimum TR = 7.3 ms, 28 slices, 10 mm slice thickness.
Time frame: Baseline comparisons between the groups
Effect of adipose-directed therapy pioglitazone on HbA1c in both men and women with normal weight diabetes
Hemoglobin A1C measures will be compared baseline to end of 16 weeks of intervention with pioglitazone.
Time frame: 16 weeks
Effect of pioglitazone in insulin resistance in both men and women.
SSPG test results will be compared from baseline to end of pioglitazone intervention. Results will be measured by glucose levels at steady state in mg/dL.
Time frame: 16 weeks
Fat storage in men with normal weight diabetes (NWD) compared to those without diabetes (NWC).
Fat storage will be measured by MRI. Quantification of subcutaneous and visceral abdominal fat will be obtained by MRI using a fat-water imaging sequence (parameters: IDEAL-IQ: 3D GRE, 160x160 matrix, 6 echoes, 4 degree flip angle, minimum TR = 7.3 ms, 28 slices, 10 mm slice thickness.
Time frame: Baseline comparisons between the groups
Adipocyte function in men with normal weight diabetes as compared with those without diabetes
Adipocyte function as measured by percent small adipocytes and peak diameter adipocytes from the fat biopsies.
Time frame: Baseline comparisons
Insulin resistance in normal weight men with diabetes compared to those with no diabetes
Insulin resistance will be measured by a Steady State Plasma Glucose test (SSPG). Results will be measured by glucose levels at steady state in mg/dL.
Time frame: Baseline measures comparison between the groups
Insulin secretion in men and women with normal weight diabetes compared to those without diabetes
A five-point, three-hour OGTT will be done after overnight fast for calculation of insulin secretion using c-peptide deconvolution, and disposition index calculated by dividing this value by SSPG.
Time frame: Baseline measured compared between the groups
Effect of adipose-directed therapy with tirzepatide on insulin resistance in men and women with normal weight diabetes (NWD).
SSPG test results will be compared from baseline to end of tirzepatide intervention. Results will be measured by glucose levels at steady state in mg/dL.
Time frame: 16 weeks
Plan to share: No
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Studies of the drugs tested here: Tirzepatide · Pioglitazone