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NCT03049462 · ClinicalTrials.gov registry record · Phase 1
The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists
A Phase 1 study of Polycystic Ovary Syndrome, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT03049462 is a Phase 1 study of Polycystic Ovary Syndrome that is actively recruiting participants, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 100 participants, below the 17,255-participant average among 30 other Polycystic Ovary Syndrome trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03049462, a Phase 1 study of Polycystic Ovary Syndrome, is actively recruiting participants, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Brown adipose tissue (BAT) is a type of fat in the body. It may prevent weight gain, improve insulin sensitivity, and reduce fatty liver. Researchers want to see if BAT helps the body burn energy. Objective: To learn more about how BAT works to burn energy. Eligibility: People ages 18-40 with a body mass index between 18 and 40 Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests Dietitian interview Participants will have an overnight baseline visit. This includes: Repeats of screening tests Exercise test Scans. For one scan, a radioactive substance is injected into the arm. FSIVGIT: An IV is inserted into veins in the right and left arms. Glucose and insulin are injected in one arm. Blood glucose and insulin levels are measured from the other. Metabolic suite: Participants stay 18-19 hours in a room that measures their metabolic rate. Monitors on the body measure heart rate, movement, and temperature. Optional fat biopsy: A small piece of tissue is removed with a needle. Participants will take 2-4 pills daily for 4 weeks. All women will take the drug mirabegron. Men will be randomly get either the drug or a placebo. All participants will have a visit after 2 weeks of the pills. They will repeat the screening tests. Participants will have an overnight visit 2 weeks later. They will repeat the baseline tests. Participants will keep food and medication diaries. Participants will have a follow-up visit 2 weeks after stopping the pills. This includes heart tests.
Conditions Studied
Interventions
- DRUG Mirabegron
- OTHER B Complex Plus Vitamin C Tablets
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2017-03-13 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03049462
The ClinicalTrials.gov registry entry for NCT03049462 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 17,255-participant average among 30 other Polycystic Ovary Syndrome trials with a reported enrollment target (99% lower). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Polycystic Ovary Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Mirabegron is the first listed.
NCT03049462 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT03049462 about?
NCT03049462 is a clinical study titled "The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists". Background: Brown adipose tissue (BAT) is a type of fat in the body. It may prevent weight gain, improve insulin sensitivity, and reduce fatty liver. Researchers want to see if BAT helps the body burn energy. Objective: To learn more about how BAT works to burn energy. Eligibility: People ages ...
What is the current status of trial NCT03049462?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2017-03-13. Estimated completion is 2026-09-30.
What conditions does trial NCT03049462 study?
This clinical trial studies the following conditions: Polycystic Ovary Syndrome.
What interventions are being tested in trial NCT03049462?
The interventions under investigation include: Mirabegron (DRUG), B Complex Plus Vitamin C Tablets (OTHER).
Who is sponsoring clinical trial NCT03049462?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03049462 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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