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Thiazolidinediones

Pioglitazone or Tirzepatide for Type 2 Diabetes

Phase 4
Waitlist Available
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Type 2 Diabetes (T2D) based on previous diagnosis or confirmed by laboratory testing at screening (A1c > 5.7% or fasting glucose > 100 mg/dL)
Age: 30 to 70 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline measured compared between the groups
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial aims to understand how fat cells function differently in people with normal-weight type 2 diabetes compared to those without diabetes. Researchers will test if certain treatments can improve insulin resistance and fat distribution in individuals

Who is the study for?
This trial is for adults aged 30-70 with normal-weight type 2 diabetes (BMI of 19-24.9) and stable body weight, not on insulin or pioglitazone but other diabetes meds are okay if stable for 3 months. It's also for similar healthy controls without diabetes.
What is being tested?
The study tests whether treatments targeting fat cells—pioglitazone and tirzepatide—can improve insulin resistance and fat distribution in those with normal-weight type 2 diabetes, compared to non-diabetic controls using various diagnostic tools.
What are the potential side effects?
Potential side effects include risk of fluid retention or heart failure with pioglitazone, especially in those predisposed. Tirzepatide may cause gastrointestinal issues like nausea or vomiting, as well as potential hypoglycemia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Type 2 Diabetes.
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I am between 30 and 70 years old.
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I am between 30 and 70 years old.
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I do not have diabetes, with normal blood sugar and no diabetes medication history.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not been diagnosed with cancer (other than skin cancer) in the last 3 years.
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I do not have any chronic inflammatory diseases.
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I have never taken the drug Pioglitazone.
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My liver and kidney functions are within normal limits.
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I have never had weight-loss surgery or liposuction.
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I do not have a history of congestive heart failure or fluid overload.
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My blood pressure is not higher than 160/90 mmHg.
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I am not currently taking any weight loss medications.
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I do not use insulin for my diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline comparisons
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline comparisons for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adipocyte function in women with normal weight diabetes as compared with those without diabetes
Fat storage in women with normal weight diabetes compared to those without diabetes
Insulin resistance in normal weight women with diabetes compared to those with no diabetes
Secondary study objectives
Adipocyte function in men with normal weight diabetes as compared with those without diabetes
Effect of adipose-directed therapy pioglitazone on HbA1c in both men and women with normal weight diabetes
Effect of pioglitazone in insulin resistance in both men and women.
+3 more
Other study objectives
Effect of adipose-directed therapy with tirzepatide on insulin resistance in men and women with normal weight diabetes (NWD).

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Normal weight with diabetes tirzepatide first pioglitazone secondExperimental Treatment8 Interventions
Baseline testing Intervention with tirzepatide for 16 weeks Retesting Washout for 5 weeks Intervention with pioglitazone for 16 weeks Retesting
Group II: Normal weight with diabetes pioglitazone first, tirzepatide secondExperimental Treatment8 Interventions
Baseline testing Intervention with pioglitazone for 16 weeks Retesting Washout for 5 weeks Intervention with tirzepatide for 16 weeks Retesting
Group III: Normal weight controlsExperimental Treatment6 Interventions
Control
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DXA scan
2023
N/A
~780
MRI
2009
Completed Phase 2
~2810
Pioglitazone
2005
Completed Phase 4
~27720
Fat biopsy
2016
Completed Early Phase 1
~30
OGTT
2007
N/A
~560
Tirzepatide
2019
Completed Phase 3
~7520

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,471 Previous Clinical Trials
17,501,894 Total Patients Enrolled
12 Trials studying Diabetes
253,380 Patients Enrolled for Diabetes
~69 spots leftby Dec 2027
Unbiased ResultsWe believe in providing patients with all the options.
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