Can fat cell therapy help Normal-Weight diabetics?
NCT ID NCT06657209
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how fat cells work differently in normal-weight people with type 2 diabetes compared to those without diabetes. Researchers will test two drugs, pioglitazone and tirzepatide, to see if they improve insulin resistance and fat storage. About 104 adults aged 30-70 will participate over 16 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pioglitazone and tirzepatide (Mounjaro)
- What this could lead to
- If successful, this could point toward better treatment options for normal-weight people with type 2 diabetes, a group often overlooked in research.
- What could go wrong
- This is a small, early-phase study with only 104 participants. Results may not apply to everyone, and the drugs have known side effects like weight gain (pioglitazone) or gastrointestinal issues (tirzepatide).
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 104 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Stanford University
RECRUITINGPalo Alto, California, 94304, United States
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Stanford University, Clinical and Translational Research Unit (CTRU)
NOT_YET_RECRUITINGStanford, California, 94304, United States
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