Normal-weight Diabetes: Adipocyte-directed Therapy With Pioglitazone or Tirzepatide
Recruiting · Palo Alto, Stanford, California
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Your choice
Voluntary — you can stop anytime
What is this study?
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.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
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 this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Aged 30 to 70 years old
- •BMI between 19 and 24.9 kg/m²
- •For the diabetes group: type 2 diabetes based on prior diagnosis or screening tests, with HbA1c between 5.7% and 8%, and stable medication/lifestyle for at least 3 months
- •For the control group: no diabetes (fasting glucose < 100 mg/dL and A1c < 5.7%) and no history of diabetes medicines
- •Body weight change no more than 2 kg over the last 3 months
🚫 You may not be able to join if…
- •Pregnant, planning pregnancy, or breastfeeding
- •Previously used pioglitazone
- •Body weight changed by more than 2 kg in the last 3 months
- •Significant liver disease (ALT > 3x the upper limit of normal) or kidney disease (creatinine > 1.5 mg/dL)
- •History of congestive heart failure or fluid overload, or uncontrolled high blood pressure (more than 160/90 mmHg)
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults age 30 to 70
- ✓BMI between 19 and 24.9 kg/m² (normal-weight range)
- ✓Type 2 diabetes with A1c between 5.7% and 8%
- ✓Must be on a stable diabetes/lifestyle plan and have stable weight (≤2 kg change)
- ✓Not pregnant or breastfeeding
- ✓Avoids certain meds/conditions like insulin and prior pioglitazone; also excludes significant liver/kidney disease and uncontrolled high blood pressure
- !Some conditions may not be a fit: Heart / cardiovascular disease, High blood pressure
- !Not for people who are pregnant or breastfeeding
How this study is designed
The real details, in plain words. Tap the underlined words to learn what they mean.
- ✓Everyone in this study receives an active treatment — there is no placebo group.
- •You'd be placed into a group by chance, like a coin flip — this keeps the study fair.
- •There are 3 groups in this study.
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
What's being tested
- Procedure: Insulin resistance testing
- Procedure: OGTT
- Procedure: Fat biopsy
- Radiation: DXA scan
- Procedure: MRI
- Procedure: 1H-MRS
- Drug: Tirzepatide
- Drug: Pioglitazone
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
Who's running this study?
Sponsor
Stanford University
Every study is also reviewed by an independent that protects participants.
What you need to know before you apply
What is this study testing?+
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.
Is it safe? Who makes sure of that?+
This is a study of an already-approved treatment (Phase 4). Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT06657209 · Locations: California