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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT06657209
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 13, 2025
Status verified
Apr 2026
Primary completion
Dec 15, 2027
Completion
Dec 15, 2027

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Insulin resistance in normal weight women with diabetes compared to those with no diabetes [ Time Frame: Baseline measures comparison between the groups ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Nina Shenoy, BS
[email protected]
408-896-0134
Alisa Turner, BS
[email protected]
650-285-8855
Stanford University, Clinical and Translational Research Unit (CTRU)StanfordCalifornia94304
Nina Shenoy, BS
[email protected]
408-896-0134
Alisa Turner, BS
[email protected]
650-285-8855
Tracey McLaughlin, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Palo Alto, CA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Stanford University· Palo Alto, CAStanford University, Clinical and Translational Research Unit (CTRU)· Stanford, CA

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