| Trial ID: | L0163 |
| Source ID: | NCT02500147
|
| Associated Drug: |
Metformin
|
| Title: |
Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)
|
| Acronym: |
--
|
| Status: |
Suspended
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Polycystic Ovary Syndrome|Non-Alcoholic Fatty Liver Disease|Metabolic Syndrome
|
| Interventions: |
Drug: Metformin|Drug: Placebo
|
| Outcome Measures: |
Difference in percentage liver fat between Metformin arm and Placebo arm in adolescents and young adults with PCOS and with elevated percentage liver fat (>/=4.8%)|Proportion of PCOS subjects with the PNPLA3 allele comparing those with elevated percentage liver fat (>/=4.8%) and those with normal percentage liver fat (<4.8%) by magnetic resonance spectroscopy|The association of percentage liver fat by magnetic resonance spectroscopy with insulin resistance as measured by HOMA-IR in adolescents with PCOS|The association of percentage liver fat with triglycerides|The association of percentage liver fat with visceral adipose tissue|The association of percentage liver fat with total body adipose tissue|The association of percentage liver fat with pancreatic polypeptide|The association of percentage liver fat with M30, a hepatic apoptosis marker
|
| Sponsor/Collaborators: |
Columbia University
|
| Gender: |
Female
|
| Age: |
13 Years to 25 Years ?? (Child, Adult)
|
| Phases: |
Phase 4
|
| Enrollment: |
46
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
|
| Start Date: |
September 8, 2011
|
| Completion Date: |
November 30, 2021
|
| Results First Posted: |
--
|
| Last Update Posted: |
February 5, 2020
|
| Locations: |
Columbia University Medical Center, New York, New York, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT02500147
|
