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Thiazolidinedione

Pioglitazone for Obesity

Rochester, MN

Phase < 1

Recruiting

Led By Michael D Jensen

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Non obese adults BMI between 18-25

Women will be premenopausal

Must not have

Initiation in patients with established New York Heart Associations (NYHA) class III or IV Heart failure.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4-9 months

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial will help researchers understand how pioglitazone helps regulate insulin in obese patients, and what role abnormal proteins in fat cells play in that process.

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Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Pioglitazone may cause side effects like fluid retention leading to swelling, potential weight gain, an increased risk of bone fractures especially in women, and could potentially worsen certain types of diabetic eye disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is between 18 and 25, so I am not obese.

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I am a woman and have not gone through menopause.

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I am between 18 and 55 years old.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe heart failure (NYHA class III or IV).

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4-9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adipocytes

Adipocyte response to insulin - adipocyte G0S2 relative to ATGL.

Adipocyte response to insulin - perilipin 1 and FSP27 relative to HSL and ATGL

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Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

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

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.

0 / 4Eligibility criteria met