Type 2 Diabetes (T2D) Clinical Trials

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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure, Radiation, Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 70
Healthy Volunteers: t
View:

⁃ Normal-Weight Diabetes (NWD) Group:

• Age: 30 to 70 years old.

• Diagnosis of Type 2 Diabetes (T2D): Based on a previous diagnosis or confirmed by laboratory testing at screening (A1c \> 5.7% or fasting glucose \> 100 mg/dL).

• HbA1c Range: Between 5.7% and 8%, with a stable medication or lifestyle regimen for at least 3 months.

• BMI: Between 19 and 24.9 kg/m².

• Diabetes Medications: All diabetes medications are allowed, except insulin and pioglitazone. GLP-1 receptor agonists are permitted if the dose has been stable for 3 months.

• Stable Body Weight: Body weight must have been stable (no more than 2 kg change) over the last 3 months.

⁃ Normal-Weight Control (NWC) Group:

• Age: 30 to 70 years old.

• No Diagnosis of Diabetes: Fasting plasma glucose \< 100 mg/dL and A1c \< 5.7%, with no history of glucose-lowering medications.

• BMI: Between 19 and 24.9 kg/m².

• Stable Body Weight: No more than 2 kg change over the past 3 months. -

Locations
United States
California
Stanford University
RECRUITING
Palo Alto
Stanford University, Clinical and Translational Research Unit (CTRU)
NOT_YET_RECRUITING
Stanford
Contact Information
Primary
Nina Shenoy, BS
nshenoy8@stanford.edu
408-896-0134
Backup
Alisa Turner, BS
alturner@stanford.edu
650-285-8855
Time Frame
Start Date: 2025-01-13
Estimated Completion Date: 2027-12-15
Participants
Target number of participants: 104
Treatments
Other: Normal weight controls
Control
Experimental: Normal weight with diabetes tirzepatide first pioglitazone second
Baseline testing Intervention with tirzepatide for 16 weeks Retesting Washout for 5 weeks Intervention with pioglitazone for 16 weeks Retesting
Experimental: Normal weight with diabetes pioglitazone first, tirzepatide second
Baseline testing Intervention with pioglitazone for 16 weeks Retesting Washout for 5 weeks Intervention with tirzepatide for 16 weeks Retesting
Related Therapeutic Areas
Sponsors
Leads: Stanford University

This content was sourced from clinicaltrials.gov