NCT06657209

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

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

Timeline

• Start date: 2024-12-15
• Primary completion: 2027-12-15
• Completion: 2027-12-15
• First posted: 2024-10-24
• Last updated: 2024-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study