| Trial ID: | L7240 |
| Source ID: | NCT02500147
|
| Associated Drug: |
Metformin
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| Title: |
Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)
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| Acronym: |
|
| Status: |
TERMINATED
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| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Polycystic Ovary Syndrome|Non-Alcoholic Fatty Liver Disease|Metabolic Syndrome
|
| Interventions: |
DRUG: Metformin|DRUG: Placebo
|
| Outcome Measures: |
Primary: 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%), 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), 6 months | Secondary: 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 proportion of PCOS subjects with the high risk I148M PNPLA3 allele in the PCOS groups with elevated and normal liver fat will be compared using a chi-squared or Fisher's Exact test., 6 months|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 percent liver fat with insulin resistance as measured by HOMA-IR will be measured by correlation/regression. Change in HOMA-IR with change in percent liver fat following metformin will be assessed using multiple regression analysis., 6 months|The association of percentage liver fat with triglycerides, The association of percent liver fat with triglycerides will be measured by correlation/regression. Change in triglycerides with change in percent liver fat following metformin will be assessed using multiple regression analysis., 6 months|The association of percentage liver fat with visceral adipose tissue, The association of percent liver fat with visceral adipose tissue will be measured by correlation/regression. Change in visceral adipose tissue with change in percent liver fat following metformin will be assessed using multiple regression analysis., 6 months|The association of percentage liver fat with total body adipose tissue, The association of percent liver fat with total body adipose tissue will be measured by correlation/regression. Change in total body adipose tissue with change in percent liver fat following metformin will be assessed using multiple regression analysis., 6 months|The association of percentage liver fat with pancreatic polypeptide, The association of percent liver fat with pancreatic polypeptide will be measured by correlation/regression. Change in pancreatic polypeptide with change in percent liver fat following metformin will be assessed using multiple regression analysis., 6 months|The association of percentage liver fat with M30, a hepatic apoptosis marker, The association of percent liver fat with M30 will be measured by correlation/regression. Change in M30 with change in percent liver fat following metformin will be assessed using multiple regression analysis., 6 months
|
| Sponsor/Collaborators: |
Sponsor: Columbia University
|
| Gender: |
FEMALE
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
6
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-09-08
|
| Completion Date: |
2021-03-03
|
| Results First Posted: |
|
| Last Update Posted: |
2024-11-21
|
| Locations: |
Columbia University Medical Center, New York, New York, 10032, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02500147
|
