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

NCT06657209 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-04-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-13
Primary Completion
2027-12-15
Completion
2027-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06657209 on ClinicalTrials.gov