Normal-weight Diabetes: Adipocyte-directed Therapy with Pioglitazone or Tirzepatide
NCT ID: NCT06657209
Last Updated: 2024-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
104 participants
INTERVENTIONAL
2024-12-15
2027-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Normal weight controls
Control
Insulin resistance testing
Steady state Plasma Glucose test
OGTT
Will collect 5 blood draws during the test to measure insulin secretion
Fat biopsy
Needle biopsy to gather a sample of abdominal subcutaneous fat
DXA scan
Whole body DXA scan
MRI
Abdominal MRI
1H-MRS
Spectroscopy of the abdominal region
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
Insulin resistance testing
Steady state Plasma Glucose test
OGTT
Will collect 5 blood draws during the test to measure insulin secretion
Fat biopsy
Needle biopsy to gather a sample of abdominal subcutaneous fat
DXA scan
Whole body DXA scan
MRI
Abdominal MRI
1H-MRS
Spectroscopy of the abdominal region
Tirzepatide
16 weeks started at 2.5mg/week and increased to 5mg/week dose
Pioglitazone
16 weeks at a 45mg/day dose
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
Insulin resistance testing
Steady state Plasma Glucose test
OGTT
Will collect 5 blood draws during the test to measure insulin secretion
Fat biopsy
Needle biopsy to gather a sample of abdominal subcutaneous fat
DXA scan
Whole body DXA scan
MRI
Abdominal MRI
1H-MRS
Spectroscopy of the abdominal region
Tirzepatide
16 weeks started at 2.5mg/week and increased to 5mg/week dose
Pioglitazone
16 weeks at a 45mg/day dose
Interventions
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Insulin resistance testing
Steady state Plasma Glucose test
OGTT
Will collect 5 blood draws during the test to measure insulin secretion
Fat biopsy
Needle biopsy to gather a sample of abdominal subcutaneous fat
DXA scan
Whole body DXA scan
MRI
Abdominal MRI
1H-MRS
Spectroscopy of the abdominal region
Tirzepatide
16 weeks started at 2.5mg/week and increased to 5mg/week dose
Pioglitazone
16 weeks at a 45mg/day dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
\-
30 Years
70 Years
ALL
Yes
Sponsors
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Stanford University
OTHER
Responsible Party
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Tracey McLaughlin
Professor of Medicine
Locations
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Stanford University, Clinical and Translational Research Unit (CTRU)
Stanford, California, United States
Countries
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Central Contacts
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Facility Contacts
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Tracey McLaughlin, MD
Role: backup
Other Identifiers
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77199
Identifier Type: -
Identifier Source: org_study_id
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