| Trial ID: | L0560 |
| Source ID: | NCT02252081
|
| Associated Drug: |
Metformin
|
| Title: |
Metformin in Kidney Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02252081/results
|
| Conditions: |
Chronic Kidney Disease|Cardiovascular Disease|Metabolic Syndrome
|
| Interventions: |
DRUG: metformin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change is Leptin to Adiponectin Ratio (LAR), Change in leptin to adiponectin ratio (LAR) after 4 months of metformin vs. placebo will be assessed as a biomarker of insulin resistance in CKD, 16 weeks after start of treatment | Secondary: Change in Flow-mediated Dilation (FMD), Change in FMD after 4 months of treatment with metformin will be compared to change in the placebo group., 16 weeks after the start of treatment|Aortic Pulse-wave Velocity (aPWV), is a measurement of stiffening of the large elastic arteries and atherosclerosis. It is a subclinical marker of cardiovascular disease, 16 weeks after starting treatment | Other: Estimated Glomerular Filtration Rate (eGFR), eGFR is a measurement of kidney function, this was a descriptive measurement, baseline and 16 weeks after starting treatment
|
| Sponsor/Collaborators: |
Sponsor: VA Office of Research and Development
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
125
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-10-01
|
| Completion Date: |
2019-12-31
|
| Results First Posted: |
2021-11-04
|
| Last Update Posted: |
2021-11-04
|
| Locations: |
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN, Nashville, Tennessee, 37212-2637, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02252081
|
