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

This study is currently recruiting participants.
Verified January 2010 by King's College Hospital NHS Trust
Sponsor:
Collaborator:
King's College London
Information provided by:
King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT01053130
First received: January 20, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted

January 20, 2010
January 20, 2010
January 2010
January 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Composite end point of death and cardiovascular outcomes (stroke, myocardial infarction or congestive heart failure hospitalisation) [ Time Frame: 0, 6, 12, 24, 36 months ] [ Designated as safety issue: No ]
  • Quality of life and anxiety and depression assessment [ Time Frame: 0, 6, 12, 24, 36 months ] [ Designated as safety issue: No ]
  • Urinary albumin to creatinine ratio and protein to creatinine ratio [ Time Frame: 0, 6, 12, 24, 36 months ] [ Designated as safety issue: No ]
  • Body composition (weight, BMI, waist and hip circ, BIA) [ Time Frame: 0, 6, 12 months ] [ Designated as safety issue: No ]
  • Insulin resistance (HOMA method) [ Time Frame: 0, 6, 12 months ] [ Designated as safety issue: No ]
  • Serum adiponectin, leptin, IL-6, TNF-α, hs-CRP, fetuin a [ Time Frame: 0, 6, 12 months ] [ Designated as safety issue: No ]
  • Urinary markers IL-6, MCP-1, IL-1β, RBP, NAG [ Time Frame: 0, 6, 12 months ] [ Designated as safety issue: No ]
  • Endothelial function (flow mediated dilatation) [ Time Frame: 0, 6, 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • Obesity
  • 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
  • Experimental: weight loss surgery
    laparoscopic sleeve gastrectomy
    Intervention: Procedure: laparoscopic sleeve gastrectomy
  • Active Comparator: Lifestyle Intervention
    Diet and exercise with or without pharmacotherapy
    Intervention: Behavioral: weight management program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
January 2014
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Helen L MacLaughlin, BSc (Hons) + 44 20 7848 0431 helen.maclaughlin@kch.nhs.uk
Contact: Iain C Macdougall, MD FRCP + 44 20 3299 9000 ext 6940 iain.macdougall@kch.nhs.uk
United Kingdom
 
NCT01053130
KCH1639, 09/H0806/69
No
Miss Helen MacLaughlin, King's College Hospital NHS Foundation Trust
King's College Hospital NHS Trust
King's College London
Not Provided
King's College Hospital NHS Trust
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP