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Thiazolidinedione

Pioglitazone for Obesity

Q: What conditions are most commonly alleviated with Deferred group - pioglitazone?

In the deferred cohort, pioglitazone is used to manage <a href="https://www.withpower.com/clinical-trials/diabetes">diabetes</a> as well as other symptoms such as diabetic neuralgia and lifestyle changes due to dietary or physical activity.

Q: Might I qualify to join this experimental research?

This clinical trial requires the recruitment of 64 individuals aged 18-55 who are classified as obese, with a BMI between 30 to 38. Furthermore, non-obese adults with BMIs ranging from 18 to 25 must also be enrolled in order for this medical study to proceed and both men and women need participate; however only premenopausal women can take part.

Q: Are there any open enrollments available for this trial?

Affirmative, the information on clinicaltrials.gov specifies that this research study is currently seeking participants. It was initially uploaded on November 12th 2018 and has since been revised on October 7th 2022. A total of 64 subjects are needed across a single site.

Q: Has the group deferring pioglitazone been previously evaluated in a clinical trial?

Currently, 31 clinical trials related to Deferred group - pioglitazone are being conducted. Of these studies, 4 of them are in their final (Phase 3) stages. This medical treatment is being explored at 69 locations across Lausanne, Vaud.

Q: Does the age threshold for this experiment extend beyond 30 years of age?

As per this trial's admission standards, potential participants must be aged between 18 and 55. For those younger than 18 or older than 65 years old, there are 202 and 622 trials respectively available to them.

Q: How many participants are involved in the ongoing clinical experiment?

Affirmative. According to the details posted on clinicaltrials.gov, this medical experiment is currently recruiting subjects. This trial was first uploaded on November 12th 2018 and modified lastly on October 7th 2022; 64 individuals are needed from 1 site.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4-9 months

Awards & highlights

Study 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.

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

Select...

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

Select...

I am a woman and have not gone through menopause.

Select...

I am between 18 and 55 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adipocytes

Adipocyte response to insulin - adipocyte G0S2 relative to ATGL.

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

+1 more

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

2,357 Previous Clinical Trials

4,315,122 Total Patients Enrolled

446 Trials studying Obesity

588,874 Patients Enrolled for Obesity

Mayo ClinicLead Sponsor

3,206 Previous Clinical Trials

3,767,019 Total Patients Enrolled

84 Trials studying Obesity

14,659 Patients Enrolled for Obesity

Michael D JensenPrincipal InvestigatorMayo Clinic

1 Previous Clinical Trials

20 Total Patients Enrolled

1 Trials studying Obesity

20 Patients Enrolled for Obesity

Media Library

Obesity Research Study Groups: Deferred control group - placebo, Immediate weight loss - placebo, Deferred group - pioglitazone, Immediate weight loss - pioglitazone

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What conditions are most commonly alleviated with Deferred group - pioglitazone?

"In the deferred cohort, pioglitazone is used to manage diabetes as well as other symptoms such as diabetic neuralgia and lifestyle changes due to dietary or physical activity."

Answered by AI

Might I qualify to join this experimental research?

"This clinical trial requires the recruitment of 64 individuals aged 18-55 who are classified as obese, with a BMI between 30 to 38. Furthermore, non-obese adults with BMIs ranging from 18 to 25 must also be enrolled in order for this medical study to proceed and both men and women need participate; however only premenopausal women can take part."

Answered by AI

Are there any open enrollments available for this trial?

"Affirmative, the information on clinicaltrials.gov specifies that this research study is currently seeking participants. It was initially uploaded on November 12th 2018 and has since been revised on October 7th 2022. A total of 64 subjects are needed across a single site."

Answered by AI

Has the group deferring pioglitazone been previously evaluated in a clinical trial?

"Currently, 31 clinical trials related to Deferred group - pioglitazone are being conducted. Of these studies, 4 of them are in their final (Phase 3) stages. This medical treatment is being explored at 69 locations across Lausanne, Vaud."

Answered by AI

Does the age threshold for this experiment extend beyond 30 years of age?

"As per this trial's admission standards, potential participants must be aged between 18 and 55. For those younger than 18 or older than 65 years old, there are 202 and 622 trials respectively available to them."

Answered by AI

How many participants are involved in the ongoing clinical experiment?

"Affirmative. According to the details posted on clinicaltrials.gov, this medical experiment is currently recruiting subjects. This trial was first uploaded on November 12th 2018 and modified lastly on October 7th 2022; 64 individuals are needed from 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Insulin Regulation of Lipolysis and Lipolysis Proteins

Michael D. Jensen 2018. "Insulin Regulation of Lipolysis and Lipolysis Proteins". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03866408.

All > Obesity