NCT03866408 Insulin Regulation of Lipolysis and Lipolysis Proteins
| NCT ID | NCT03866408 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Mayo Clinic |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2018-11-12 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 64 participants in total. It began in 2018-11-12 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Men and Women between the ages of 18 and 55. * Women will be premenopausal * Non obese adults BMI between 18-25 * Obese BMI 30-38 Exclusion Criteria, Pioglitazone package insert of contraindications for use: * Initiation in patients with established New York Heart Associations (NYHA) class III or IV Heart failure. * Use in patients with known hypersensitivity to pioglitazone or any other component of ACTOSE.
Contact & Investigator
Michael D Jensen
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT03866408 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03866408 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03866408 currently recruiting?
Yes, NCT03866408 is actively recruiting participants. Visit ClinicalTrials.gov or contact Mayo Clinic to inquire about joining.
Where is the NCT03866408 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT03866408 clinical trial?
NCT03866408 is sponsored by Mayo Clinic. The principal investigator is Michael D Jensen at Mayo Clinic. The trial plans to enroll 64 participants.
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