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Normal-weight Diabetes: Adipocyte-directed Therapy With Pioglitazone or Tirzepatide
Lead sponsor
Asset
Tirzepatide
Subcutaneous · GLP-1 / GIP dual
Listed sites
2
Recruiting sites
1
Enrollment
104
estimated
Study population
Healthy volunteers, Type 2 diabetes
Key I/E criteria
•BMI 19-24.9•HbA1c ≥5.7%
Primary endpoints
•Insulin resistance in normal weight women with diabetes•Adipocyte function•Fat storage
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Normal-Weight Diabetes (NWD) Group:
1. Age: 30 to 70 years old.
2. 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).
3. HbA1c Range: Between 5.7% and 8%, with a stable medication or lifestyle regimen for at least 3 months.
4. BMI: Between 19 and 24.9 kg/m².
5. 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.
6. 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:
1. Age: 30 to 70 years old.
2. No Diagnosis of Diabetes: Fasting plasma glucose < 100 mg/dL and A1c < 5.7%, with no history of glucose-lowering medications.
3. BMI: Between 19 and 24.9 kg/m².
4. Stable Body Weight: No more than 2 kg change over the past 3 months. -
Exclusion criteria
1. Pregnancy or Lactation: Women who are pregnant, planning to become pregnant, or breastfeeding are excluded due to potential risks to the fetus or infant.
2. Prior Use of Pioglitazone: Participants who have previously used pioglitazone are excluded to avoid confounding effects of prior drug exposure.
3. 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.
4. 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.
5. Congestive Heart Failure or Fluid Overload History: These conditions are exclusionary due to the risk of fluid retention with pioglitazone.
6. Uncontrolled Hypertension: Blood pressure > 160/90 mmHg excludes participants due to increased cardiovascular risk.
7. Active Cancer: Individuals with a diagnosis of cancer in the past 3 years (except for skin cancer) are excluded.
8. Chronic Inflammatory Diseases: Excluded due to potential effects on metabolic measurements.
9. Use of Weight Loss Medications: Those currently taking weight loss medications are excluded to prevent confounding effects on body weight and metabolic function.
10. Bariatric Surgery or Liposuction History: Participants who have had weight-loss surgeries or liposuction are excluded due to alterations in fat tissue and metabolic profiles.
11. Insulin Use: Participants using insulin are excluded to focus on non-insulin-dependent diabetes.
12. Active Psychiatric Disease or Eating Disorders: Individuals with these conditions are excluded due to potential impacts on study compliance and data integrity.
13. Substance Abuse: Participants with a history of substance abuse are excluded for similar reasons.
Endpoints (10)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
4 endpointsAdipocyte function in women with normal weight diabetes as compared with those without diabetes
Time frame:Baseline comparisons
descriptive
Fat storage in women with normal weight diabetes compared to those without diabetes
Time frame:Baseline comparisons between the groups
descriptive
Fat storage in men with normal weight diabetes (NWD) compared to those without diabetes (NWC).
Time frame:Baseline comparisons between the groups
descriptive
Adipocyte function in men with normal weight diabetes as compared with those without diabetes
Time frame:Baseline comparisons
descriptive
componentspercent small adipocytes, peak adipocyte diameter
Glycemic / diabetes
6 endpointsInsulin resistance in normal weight women with diabetes compared to those with no diabetes
Time frame:Baseline measures comparison between the groups
descriptive
Effect of adipose-directed therapy pioglitazone on HbA1c in both men and women with normal weight diabetes
Time frame:16 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Effect of pioglitazone in insulin resistance in both men and women.
Time frame:16 weeks
change from baseline, improvement
Insulin resistance in normal weight men with diabetes compared to those with no diabetes
Time frame:Baseline measures comparison between the groups
descriptive
Insulin secretion in men and women with normal weight diabetes compared to those without diabetes
Time frame:Baseline measured compared between the groups
descriptive
Effect of adipose-directed therapy with tirzepatide on insulin resistance in men and women with normal weight diabetes (NWD).
Time frame:16 weeks
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.