Normal-weight Diabetes: Adipocyte-directed Therapy With Pioglitazone or Tirzepatide
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age30-70
SponsorStanford University
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Pregnancy or Lactation: Women who are pregnant, planning to become pregnant, or breastfeeding are excluded due to potential risks to the fetus or infant.
Prior Use of Pioglitazone: Participants who have previously used pioglitazone are excluded to avoid confounding effects of prior drug exposure.
Unstable Body Weight: Individuals with a body weight change of more than 2 kg in the last 3 months are excluded to ensure stable metabolic conditions.
Liver or Kidney Disease: Participants with significant liver disease (ALT > 3x upper limit of normal) or renal disease (creatinine > 1.5 mg/dL) are excluded due to potential safety risks.
Trial design
Treatments tested in this trial
- Insulin resistance testing
- OGTT
- Fat biopsy
- DXA scan
- MRI
- 1H-MRS
- Tirzepatide
- Pioglitazone
Treatment groups
104 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov