Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
64 participants
INTERVENTIONAL
2018-11-12
2026-12-31
Brief Summary
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Detailed Description
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2. The investigators will determine whether the improved insulin regulation of lipolysis resulting from treatment with the PPARĪ³ agonist pioglitazone, with or without weight loss, can be linked to specific changes in sets of PPARĪ³-responsive adipocyte lipolysis proteins in UBO adults.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Immediate weight loss - placebo
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.
Immediate weight loss
Upper body obese subjects will undergo behavioral intervention with a life coach and a physical activity program of their choice for 4 months.
Placebo
Upper body obese subjects will be block randomized to pioglitazone or placebo at enrollment.
Deferred control group - placebo
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.
Deferred weight loss
Upper body obese subjects will complete a weight-stable period of 4 months and subsequently undergo behavioral intervention with a life coach and a physical activity program of their choice for 4 months.
Placebo
Upper body obese subjects will be block randomized to pioglitazone or placebo at enrollment.
Immediate weight loss - pioglitazone
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.
Immediate weight loss
Upper body obese subjects will undergo behavioral intervention with a life coach and a physical activity program of their choice for 4 months.
Pioglitazone
Upper body obese subjects will be block randomized to pioglitazone or placebo at enrollment.
Deferred group - pioglitazone
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.
Pioglitazone
Upper body obese subjects will be block randomized to pioglitazone or placebo at enrollment.
Deferred weight loss
Upper body obese subjects will complete a weight-stable period of 4 months and subsequently undergo behavioral intervention with a life coach and a physical activity program of their choice for 4 months.
Interventions
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Immediate weight loss
Upper body obese subjects will undergo behavioral intervention with a life coach and a physical activity program of their choice for 4 months.
Pioglitazone
Upper body obese subjects will be block randomized to pioglitazone or placebo at enrollment.
Deferred weight loss
Upper body obese subjects will complete a weight-stable period of 4 months and subsequently undergo behavioral intervention with a life coach and a physical activity program of their choice for 4 months.
Placebo
Upper body obese subjects will be block randomized to pioglitazone or placebo at enrollment.
Eligibility Criteria
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Inclusion Criteria
* Women will be premenopausal
* Non obese adults BMI between 18-25
* Obese BMI 30-38
Exclusion Criteria
* Use in patients with known hypersensitivity to pioglitazone or any other component of ACTOSE.
18 Years
55 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Mayo Clinic
OTHER
Responsible Party
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Michael D. Jensen
Principal Investigator
Principal Investigators
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Michael D Jensen
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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17-009837
Identifier Type: -
Identifier Source: org_study_id
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