Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 37 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01180101
The ClinicalTrials.gov registry entry for NCT01180101 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Bariatric Surgery is the first listed.
NCT01180101 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.