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NCT02252081 · ClinicalTrials.gov registry record · Phase 2
Metformin in Kidney Disease
A Phase 2 study of Cardiovascular Disease and Metabolic Syndrome, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 125
- Enrollment target
- 1
- Study location
NCT02252081: Completed Phase 2 study of Cardiovascular Disease and Metabolic Syndrome, sponsored by VA Office of Research and Development.
NCT02252081 is a Phase 2 study of Cardiovascular Disease and Metabolic Syndrome that has completed, run by VA Office of Research and Development. The registered enrollment target is 125 participants, below the 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02252081, a Phase 2 study of Cardiovascular Disease and Metabolic Syndrome, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 125 participants
- Enrollment target
- 1
- Study location
Study Summary
Chronic kidney disease (CKD) is a major global health problem associated with substantial costs and resource utilization. Currently, CKD affects more than 500 million people worldwide. Patients with CKD have unacceptably high mortality rates due to cardiovascular (CV) causes, which are not entirely explained by traditional CV risk factors. The mortality rates in advanced CKD are six times higher compared to the Medicare population, with CVD accounting for the overwhelming majority of deaths. Insulin resistance (IR) is common in CKD patients and may represent a central link between CKD and the increased CVD risk observed in this population. Insulin resistance may increase CV risk by impairing and worsening endothelial function, increasing reactive oxygen species, and exacerbating systemic inflammation-hence, insulin resistance is considered a "non-traditional CV risk factor" in CKD. Obesity (defined by a body mass index \[BMI\] of at least 30 kg/m2) is a major public health problem-the upward trend in obesity prevalence across regions and continents is a worldwide concern. Obesity increases the risk for cardiovascular disease and death. In the general population, obesity hastens death by 9.4 years. Obesity is an independent risk factor for CKD. Besides its contribution to the development of diabetes and hypertension, increased fat mass may also have a direct impact on kidney function. In spite of the increasing prevalence of both obesity and CKD, the impact of obesity in the CKD population is not known, especially in terms of the exaggerated metabolic disturbances associated with their coexistence. It is highly likely that these two conditions have profound interactions that exaggerate the severity of the metabolic derangements when they coexist, particularly in regards to adipokine dysregulation, the risk of "insulin resistance", and downstream effects on vascular health. The current proposal will attempt to characterize the relative and combined impact of both ob
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG metformin
Study Locations (1)
Tennessee
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2014-10-01 |
| Est. Completion | 2019-12-31 |
| Phase | Phase 2 |
What the finished NCT02252081 record still lists
NCT02252081 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Cardiovascular Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02252081 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT02252081 about?
NCT02252081 is a clinical study titled "Metformin in Kidney Disease". Chronic kidney disease (CKD) is a major global health problem associated with substantial costs and resource utilization. Currently, CKD affects more than 500 million people worldwide. Patients with CKD have unacceptably high mortality rates due to cardiovascular (CV) causes, which are not entirely ...
What is the current status of trial NCT02252081?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2014-10-01. Estimated completion is 2019-12-31.
What conditions does trial NCT02252081 study?
This clinical trial studies the following conditions: Cardiovascular Disease, Metabolic Syndrome, Chronic Kidney Disease.
What interventions are being tested in trial NCT02252081?
The interventions under investigation include: Placebo (DRUG), metformin (DRUG).
Who is sponsoring clinical trial NCT02252081?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02252081 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02252081's enrollment target sits among peer trials
125 66th of 137 higher than 71 of 137 other Cardiovascular Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Disease 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.
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