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Trial record 60 of 69 for:    ORLISTAT

Weight Loss Interventions in Obese Patients With Stages 3-4 Chronic Kidney Disease: a Randomised Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01053130
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : June 9, 2016
King's College London
Information provided by:
King's College Hospital NHS Trust

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Obesity Procedure: laparoscopic sleeve gastrectomy Behavioral: weight management program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: weight loss surgery
laparoscopic sleeve gastrectomy
Procedure: laparoscopic sleeve gastrectomy
laparoscopic sleeve gastrectomy plus dietary and physical activity support

Active Comparator: Lifestyle Intervention
Diet and exercise with or without pharmacotherapy
Behavioral: weight management program
1200-1500 kcal renal diet, increased physical activity, with optional orlistat therapy at 120 mg tds for 12 months

Primary Outcome Measures :
  1. Measured glomerular filtration rate (renal function) using the iohexol clearance method in patients with stages 3-4 chronic kidney disease [ Time Frame: 0, 6, 12 months ]

Secondary Outcome Measures :
  1. Composite end point of death and cardiovascular outcomes (stroke, myocardial infarction or congestive heart failure hospitalisation) [ Time Frame: 0, 6, 12, 24, 36 months ]
  2. Quality of life and anxiety and depression assessment [ Time Frame: 0, 6, 12, 24, 36 months ]
  3. Urinary albumin to creatinine ratio and protein to creatinine ratio [ Time Frame: 0, 6, 12, 24, 36 months ]
  4. Body composition (weight, BMI, waist and hip circ, BIA) [ Time Frame: 0, 6, 12 months ]
  5. Insulin resistance (HOMA method) [ Time Frame: 0, 6, 12 months ]
  6. Serum adiponectin, leptin, IL-6, TNF-α, hs-CRP, fetuin a [ Time Frame: 0, 6, 12 months ]
  7. Urinary markers IL-6, MCP-1, IL-1β, RBP, NAG [ Time Frame: 0, 6, 12 months ]
  8. Endothelial function (flow mediated dilatation) [ Time Frame: 0, 6, 12 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Stages 3-4 CKD patients (GFR 20-60 mL/min)
  • Male or female
  • BMI 35-45 kg/m2
  • Aged >18 years
  • Previously attempted weight loss
  • Fit or anesthesia and surgery
  • Written informed consent

Exclusion Criteria:

  • Pregnancy
  • History of chronic liver disease
  • Previous gastric surgery or large hiatus hernia
  • Previous bariatric surgery
  • Psychiatric illness, including anxiety, mood and untreated eating disorders
  • Malnutrition (assessed by subjective global assessment)
  • Infection or course of antibiotics within the last month
  • Unwilling to consider surgical treatment
  • Previous kidney transplant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01053130

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United Kingdom
King's College Hospital
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
King's College Hospital NHS Trust
King's College London

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Responsible Party: Miss Helen MacLaughlin, King's College Hospital NHS Foundation Trust Identifier: NCT01053130     History of Changes
Other Study ID Numbers: KCH1639
09/H0806/69 ( Other Identifier: UK Research Ethics Committee registration )
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: January 2010
Keywords provided by King's College Hospital NHS Trust:
bariatric surgery
chronic kidney disease
weight loss
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Weight Loss
Body Weight
Signs and Symptoms
Urologic Diseases
Renal Insufficiency
Body Weight Changes