Trials / Completed
CompletedNCT01053130
Weight Loss Interventions in Obese Patients With Stages 3-4 Chronic Kidney Disease: a Randomised Controlled Trial
The Effect of Weight Loss Surgery on Preservation of Kidney Function and Cardiovascular Disease Risk Factors in Obese Patients With Stages 3-4 Chronic Kidney Disease: a Randomised Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- King's College Hospital NHS Trust · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Weight loss surgery is the most effective weight loss treatment available, but the direct effect on chronic kidney disease is less widely understood. Early research shows some improvement in kidney function may occur and candidacy for kidney transplantation can be improved with weight loss following surgery. To date, no randomised controlled trial has been performed to examine the effect of weight loss surgery on the progression of chronic kidney disease. This randomised trial will allocate patients to either lifestyle modification with diet, exercise and pharmacotherapy, or weight loss surgery to remove two thirds of the stomach using the laparoscopic sleeve gastrectomy procedure. This study aims to evaluate weight loss surgery vs lifestyle modification in patients with chronic kidney disease with estimated kidney function of 20-60% and morbid obesity (BMI 35-45) in terms of kidney function, cardiovascular disease risk factors and all-cause mortality.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | laparoscopic sleeve gastrectomy | laparoscopic sleeve gastrectomy plus dietary and physical activity support |
| BEHAVIORAL | weight management program | 1200-1500 kcal renal diet, increased physical activity, with optional orlistat therapy at 120 mg tds for 12 months |
Timeline
- Start date
- 2010-01-01
- Primary completion
- 2013-01-01
- Completion
- 2013-01-01
- First posted
- 2010-01-21
- Last updated
- 2016-06-09
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01053130. Inclusion in this directory is not an endorsement.