~6 spots leftby Dec 2025

Pioglitazone for Obesity

MD
Overseen byMichael D Jensen
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Mayo Clinic
Must be taking: Pioglitazone
Disqualifiers: Heart failure, Hypersensitivity, others
Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

These studies will define the abnormalities in the adipocyte proteins that are involved in the failure of insulin to suppress lipolysis normally in humans with upper body obesity and will help discover the mechanism by which pioglitazone, a medication used to treat type 2 diabetes and improve insulin resistance, improves insulin-regulation of adipocyte fatty acid metabolism.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Pioglitazone for obesity?

While there is no direct evidence from the provided research about Pioglitazone's effectiveness for obesity, it is known to improve insulin sensitivity and reduce cardiovascular risk in patients with type 2 diabetes, which might indirectly suggest potential benefits for weight management.12345

Is pioglitazone safe for humans?

Pioglitazone has been generally well tolerated in clinical trials, with common side effects including weight gain and swelling. However, it has been associated with an increased risk of bladder cancer, heart failure, and bone fractures in postmenopausal women. It is important to weigh these risks against the benefits when considering its use.16789

How does the drug pioglitazone differ from other treatments for obesity?

Pioglitazone is unique because it is primarily used to treat type 2 diabetes by improving insulin sensitivity, which may indirectly affect weight. Unlike other obesity treatments, it works by altering gene expression to reduce insulin resistance, potentially offering a novel approach to managing obesity.13101112

Research Team

MD

Michael D Jensen

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for men and women aged 18-55, including premenopausal women. It's suitable for non-obese adults with a BMI of 18-25 and obese individuals with a BMI of 30-38. People allergic to pioglitazone or with severe heart failure (NYHA class III/IV) cannot participate.

Inclusion Criteria

Obese BMI 30-38
My BMI is between 18 and 25, so I am not obese.
I am a woman and have not gone through menopause.
See 1 more

Exclusion Criteria

Use in patients with known hypersensitivity to pioglitazone or any other component of ACTOSE.
I have severe heart failure (NYHA class III or IV).

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Studies

Participants undergo baseline studies to assess initial conditions and measurements

2 weeks

Deferred Control Group - Placebo

Participants wait without any intervention for 4 months, with continued monitoring to assure weight stability

4 months

Immediate Weight Loss - Placebo

Participants begin immediate participation in a comprehensive lifestyle obesity treatment program

4 months

Deferred Group - Pioglitazone

Participants wait without any intervention for 4 months, monitored to prevent weight gain, while on pioglitazone

4 months

Immediate Weight Loss - Pioglitazone

Participants begin immediate participation in a comprehensive lifestyle obesity treatment program with pioglitazone

4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-9 months

Treatment Details

Interventions

  • Deferred weight loss (Behavioral Intervention)
  • Immediate weight loss (Behavioral Intervention)
  • Pioglitazone (Thiazolidinedione)
  • Placebo (Drug)
Trial OverviewThe study investigates how the drug Pioglitazone affects fat cell metabolism in those with upper body obesity. It compares immediate weight loss strategies, deferred weight loss plans, and placebo effects on insulin's ability to control fat breakdown.
Participant Groups
4Treatment groups
Active Control
Placebo Group
Group I: Immediate weight loss - placeboActive Control2 Interventions
Upper body obese participants randomized to this group; all will begin their immediate participation in a comprehensive lifestyle obesity treatment program after completion of baseline studies. Half of the volunteers will be randomized to placebo during this period.
Group II: Deferred group - pioglitazoneActive Control2 Interventions
After baseline studies, UBO participants randomized to this group will wait without any intervention for 4 months, with continued monitoring to assure weight stability - this group will be the half of volunteers randomized to deferred weight loss intervention that are randomized to pioglitazone. They will be monitored to prevent the usual but modest weight gain associated with pioglitazone. They will be on pioglitazone during the 'wait' period. At the end of this 'wait' period they will be enrolled in the same comprehensive lifestyle obesity treatment program for 4 months, but without pioglitazone.
Group III: Immediate weight loss - pioglitazoneActive Control2 Interventions
Upper body obese participants randomized to this group; all will begin their immediate participation in a comprehensive lifestyle obesity treatment program after completion of baseline studies. Half of the volunteers will be randomized to pioglitazone during this period.
Group IV: Deferred control group - placeboPlacebo Group2 Interventions
After baseline studies, UBO participants randomized to this group will wait without any intervention for 4 months, with continued monitoring to assure weight stability - this group will be the half of volunteers randomized to deferred weight loss intervention that are also randomized to placebo. At the end of this 'wait' period they will be enrolled in the same comprehensive lifestyle obesity treatment program for 4 months, but without placebo.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Findings from Research

Pioglitazone effectively increases insulin sensitivity and improves glycemic control in patients with type 2 diabetes, whether used alone or in combination with other medications, based on clinical trials.
The medication is generally well tolerated, with weight gain and edema being the most common side effects, and it also shows potential benefits in reducing cardiovascular risk and arteriosclerosis.
Spotlight on pioglitazone in type 2 diabetes mellitus.Waugh, J., Keating, GM., Plosker, GL., et al.[2019]
Pioglitazone effectively reduces glycosylated hemoglobin (HbA1c) levels in patients with type 2 diabetes, showing similar efficacy in both younger (<65 years) and older (≥65 years) age groups, with reductions of 0.53-1.27% observed in monotherapy studies.
The addition of pioglitazone to other diabetes medications (sulfonylureas, metformin, or insulin) also resulted in significant HbA1c reductions, with no major differences in effectiveness or adverse events between age groups, although hypoglycemia rates varied depending on the combination therapy.
Pioglitazone is effective therapy for elderly patients with type 2 diabetes mellitus.Rajagopalan, R., Perez, A., Ye, Z., et al.[2022]
In a study of 186 patients switched from troglitazone to either pioglitazone or rosiglitazone, both groups showed no significant change in glycemic control (HbA1c levels) after 4 months, indicating similar efficacy in managing blood sugar levels.
However, the pioglitazone group experienced a significant improvement in lipid profiles, with an average decrease in total cholesterol of about 20 mg/dl, while the rosiglitazone group showed no such improvement, highlighting a potential advantage of pioglitazone in lipid management.
A prospective, randomized comparison of the metabolic effects of pioglitazone or rosiglitazone in patients with type 2 diabetes who were previously treated with troglitazone.Khan, MA., St Peter, JV., Xue, JL.[2022]

References

Spotlight on pioglitazone in type 2 diabetes mellitus. [2019]
Pioglitazone is effective therapy for elderly patients with type 2 diabetes mellitus. [2022]
A prospective, randomized comparison of the metabolic effects of pioglitazone or rosiglitazone in patients with type 2 diabetes who were previously treated with troglitazone. [2022]
Adding pioglitazone to insulin containing regimens in type 2 diabetes: systematic review and meta-analysis. [2021]
Pioglitazone hydrochloride in combination with metformin in the treatment of type 2 diabetes mellitus: a randomized, placebo-controlled study. The Pioglitazone 027 Study Group. [2022]
Safety profile of pioglitazone. [2022]
Pioglitazone: Indian perspective. [2021]
[Limitations of insulin-dependent drugs in the treatment of type 2 diabetes mellitus]. [2018]
Adverse drug effects observed with vildagliptin versus pioglitazone or rosiglitazone in the treatment of patients with type 2 diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials. [2018]
Efficacy and safety of generic and original pioglitazone in type 2 diabetes mellitus: a multicenter, a double-blinded, randomized-controlled study. [2022]
Truncated areas under the curve in the assessment of pioglitazone bioequivalence. Data from a single-center, single-dose, randomized, open-label, 2-way cross-over bioequivalence study of two formulations of pioglitazone 45 mg tablets under fasting conditions. [2018]
Pioglitazone. [2018]