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NCT02500147 · ClinicalTrials.gov registry record · Phase 4
Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)
A Phase 4 study, sponsored by Columbia University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 3
- Enrollment target
NCT02500147: Clinical Trial Phase 4 study, sponsored by Columbia University.
NCT02500147 is a Phase 4 study that was terminated before completion, run by Columbia University. The registered enrollment target is 3 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02500147, a Phase 4 study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 3 participants
- Enrollment target
Study Summary
This project, "A double-blind placebo-controlled randomized clinical trial assessing the efficacy of metformin for hepatic fat in adolescents and young adults with polycystic ovary syndrome", proposes exploring the use of novel and noninvasive methodologies in an at-risk adolescent and young adult population with polycystic ovary syndrome (PCOS) who may gain long-term health benefits from early detection and treatment of non-alcoholic fatty liver disease (NAFLD). PCOS is a common condition that frequently presents in adolescence and young adulthood and is defined by elevated androgens (male hormones) in the blood leading to 1. hirsutism and acne and 2. menstrual abnormalities or amenorrhea. Affected individuals are at increased risk of developing insulin resistance (a precursor of diabetes), NAFLD and lipid (cholesterol) abnormalities.These features are all associated with the metabolic syndrome, a rising major public health concern. Recently, an association between PCOS and NAFLD has been noted but has only been superficially studied in the adolescent and young adult population. The susceptibility of certain PCOS patients to developing NAFLD is theorized to be due to having underlying insulin resistance, elevated androgen levels, and a genetic predisposition. Metformin is an insulin sensitizing medication widely used to treat type 2 diabetes mellitus that may have beneficial effects on insulin resistance-related conditions including PCOS and NAFLD. Although widely used in PCOS, its effect on NAFLD in this group has not been previously studied. The primary aims of this proposal are: 1) To determine whether PCOS with liver fat \>/=4.8% treated with metformin for six months will have a decline in percentage liver fat compared to a placebo group. 2) To measure the association of the PNPLA3 I148M allele with NAFLD in PCOS at baseline (n=40). 2b) To measure the association of percentage liver fat with biomarkers of NAFLD, dyslipidemia, insulin resistance and body compos
Primary Outcome
To compare percentage liver fat by magnetic resonance spectroscopy in the metformin group and placebo group to baseline and between the groups in order to determine if metformin is efficacious for reducing liver fat compared to placebo in adolescents and young women with Polycystic Ovary Syndrome (PCOS)
Interventions
- DRUG Placebo
- DRUG Metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2011-09-08 |
| Est. Completion | 2021-03-03 |
| Phase | Phase 4 |
Why NCT02500147 stopped before completion
NCT02500147 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02500147 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02500147 about?
NCT02500147 is a clinical study titled "Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)". This project, "A double-blind placebo-controlled randomized clinical trial assessing the efficacy of metformin for hepatic fat in adolescents and young adults with polycystic ovary syndrome", proposes exploring the use of novel and noninvasive methodologies in an at-risk adolescent and young adult p...
What is the current status of trial NCT02500147?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2011-09-08. Estimated completion is 2021-03-03.
What interventions are being tested in trial NCT02500147?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG).
Who is sponsoring clinical trial NCT02500147?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02500147's enrollment target sits among peer trials
3 1995th of 2000 higher than 3 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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