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Tirzepatide

Mounjaro, Zepbound, LY3298176

Quick Stats
Studies 183
Trials 100
Not Yet Recruiting PHASE4 INTERVENTIONAL NCT06657209

Normal-weight Diabetes: Adipocyte-directed Therapy with Pioglitazone or Tirzepatide

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This study is to investigate how adipocyte (fat cell) function and fat distribution differ between individuals with normal-weight type 2 diabetes (NWD) 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.

Detailed Description

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.

Interventions

Name: Insulin resistance testing
Type: PROCEDURE
Description: Steady state Plasma Glucose test
Name: OGTT
Type: PROCEDURE
Description: Will collect 5 blood draws during the test to measure insulin secretion
Name: Fat biopsy
Type: PROCEDURE
Description: Needle biopsy to gather a sample of abdominal subcutaneous fat
Name: DXA scan
Type: RADIATION
Description: Whole body DXA scan
Name: MRI
Type: PROCEDURE
Description: Abdominal MRI
Name: 1H-MRS
Type: PROCEDURE
Description: Spectroscopy of the abdominal region
Name: Tirzepatide
Type: DRUG
Description: 16 weeks started at 2.5mg/week and increased to 5mg/week dose
Name: Pioglitazone
Type: DRUG
Description: 16 weeks at a 45mg/day dose

Primary Outcomes

Measure: Insulin resistance in normal weight women with diabetes compared to those with no diabetes
TimeFrame: Baseline measures comparison between the groups
Description: 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.
Measure: Adipocyte function in women with normal weight diabetes as compared with those without diabetes
TimeFrame: Baseline comparisons
Description: Adipocyte function will be measured as percent small adipocytes and peak diameter adipocytes from the fat biopsies.
Measure: Fat storage in women with normal weight diabetes compared to those without diabetes
TimeFrame: Baseline comparisons between the groups
Description: 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.

Trial Information

NCT ID

NCT06657209

Status

Not Yet Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE4

Sponsor

Stanford University

Last Updated

December 15, 2025