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NCT01180101 · ClinicalTrials.gov registry record · Phase 2
Effects of Intentional Weight Loss Interventions in Chronic Kidney Disease
A Phase 2 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT01180101: Completed Phase 2 study, sponsored by The Cleveland Clinic.
NCT01180101 is a Phase 2 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01180101, a Phase 2 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study Summary
Obesity is an established risk factor for development and progression of kidney disease. Intentional weight loss in people without kidney disease results in an improvement in diabetes, blood pressure, cholesterol, cardiovascular disease and overall death rates. The investigators do not know whether this holds true in patients with chronic kidney disease. In the proposed pilot study, the investigators will analyze if kidney function stabilizes after weight loss interventions in obese kidney disease patients and the mechanisms that might mediate this beneficial effect. If weight loss in kidney disease patients results in stabilization of kidney function, this would provide an opportunity to conduct a long-term prospective study to analyze the sustained benefits of weight loss in kidney disease patients. Specific aim 1: To ascertain the effects of lifestyle modification or bariatric surgery on urinary protein excretion and renal function among obese CKD patients. Hypothesis: Weight loss attained through either lifestyle modification or surgical intervention will result in lowering of urinary protein excretion and stabilization of renal function among obese CKD patients. Specific aim 2: To identify the mechanism that mediates the change in urinary protein excretion and renal function among obese CKD patients undergoing lifestyle modification or bariatric surgery. Hypothesis: Weight loss attained through either lifestyle modification or surgical intervention will result in amelioration of endothelial dysfunction, inflammation, insulin resistance and an increase in High Molecular Weight (HMW) adiponectin levels that then mediate the improvement in urinary protein excretion and renal function among obese CKD patients.
Primary Outcome
Weight loss attained through either lifestyle modification or surgical intervention will result in lowering of urinary protein excretion and stabilization of renal function among obese CKD patients.
Interventions
- PROCEDURE Bariatric Surgery
- BEHAVIORAL Diet and exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2010-08 |
| Est. Completion | 2014-12 |
| Phase | Phase 2 |
What the finished NCT01180101 record still lists
NCT01180101 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Bariatric Surgery is the first listed.
NCT01180101 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01180101 about?
NCT01180101 is a clinical study titled "Effects of Intentional Weight Loss Interventions in Chronic Kidney Disease". Obesity is an established risk factor for development and progression of kidney disease. Intentional weight loss in people without kidney disease results in an improvement in diabetes, blood pressure, cholesterol, cardiovascular disease and overall death rates. The investigators do not know whether ...
What is the current status of trial NCT01180101?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2010-08. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01180101?
The interventions under investigation include: Bariatric Surgery (PROCEDURE), Diet and exercise (BEHAVIORAL).
Who is sponsoring clinical trial NCT01180101?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01180101's enrollment target sits among peer trials
37 1484th of 2000 higher than 505 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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