Normal-weight Diabetes: Adipocyte-directed Therapy With Pioglitazone or Tirzepatide (NCT06657209) | Clinical Trial Compass
RecruitingPhase 4
Normal-weight Diabetes: Adipocyte-directed Therapy With Pioglitazone or Tirzepatide
United States104 participantsStarted 2025-01-13
Plain-language 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.
Who can participate
Age range30 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
Exclusion criteria
✕. Pregnancy or Lactation: Women who are pregnant, planning to become pregnant, or breastfeeding are excluded due to potential risks to the fetus or infant.
What they're measuring
1
Insulin resistance in normal weight women with diabetes compared to those with no diabetes
Timeframe: Baseline measures comparison between the groups
2
Adipocyte function in women with normal weight diabetes as compared with those without diabetes
Timeframe: Baseline comparisons
3
Fat storage in women with normal weight diabetes compared to those without diabetes
Timeframe: Baseline comparisons between the groups
✕. 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.
✕. Congestive Heart Failure or Fluid Overload History: These conditions are exclusionary due to the risk of fluid retention with pioglitazone.
✕. Uncontrolled Hypertension: Blood pressure \> 160/90 mmHg excludes participants due to increased cardiovascular risk.
✕. Active Cancer: Individuals with a diagnosis of cancer in the past 3 years (except for skin cancer) are excluded.
✕. Chronic Inflammatory Diseases: Excluded due to potential effects on metabolic measurements.