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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
  Purpose

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 Intervention
Chronic Kidney Disease
Obesity
 Procedure: laparoscopic sleeve gastrectomy
Behavioral: weight management program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by King's College Hospital NHS Trust:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: January 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053130

Contacts
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

Locations
United Kingdom
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Principal Investigator: Helen L MacLaughlin, BSc (Hons)            
Sponsors and Collaborators
King's College Hospital NHS Trust
King's College London
  More Information

No publications provided

Responsible Party: Miss Helen MacLaughlin, King's College Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01053130     History of Changes
Other Study ID Numbers: KCH1639, 09/H0806/69
Study First Received: January 20, 2010
Last Updated: January 20, 2010
Health Authority: United Kingdom: National Institute for Health Research

Keywords provided by King's College Hospital NHS Trust:
obesity
bariatric surgery
chronic kidney disease
weight loss
exercise

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Obesity
Weight Loss
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes
Renal Insufficiency

ClinicalTrials.gov processed this record on June 18, 2013