NCT01053130

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 21, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

June 9, 2016

Status Verified

January 1, 2010

Enrollment Period

3 years

First QC Date

January 20, 2010

Last Update Submit

June 8, 2016

Conditions

Chronic Kidney DiseaseObesity

Keywords

obesitybariatric surgerychronic kidney diseaseweight lossexercise

Outcome Measures

Primary Outcomes (1)

  • Measured glomerular filtration rate (renal function) using the iohexol clearance method in patients with stages 3-4 chronic kidney disease

    0, 6, 12 months

Secondary Outcomes (8)

  • Composite end point of death and cardiovascular outcomes (stroke, myocardial infarction or congestive heart failure hospitalisation)

    0, 6, 12, 24, 36 months

  • Quality of life and anxiety and depression assessment

    0, 6, 12, 24, 36 months

  • Urinary albumin to creatinine ratio and protein to creatinine ratio

    0, 6, 12, 24, 36 months

  • Body composition (weight, BMI, waist and hip circ, BIA)

    0, 6, 12 months

  • Insulin resistance (HOMA method)

    0, 6, 12 months

  • +3 more secondary outcomes

Study Arms (2)

weight loss surgery

EXPERIMENTAL

laparoscopic sleeve gastrectomy

Procedure: laparoscopic sleeve gastrectomy

Lifestyle Intervention

ACTIVE COMPARATOR

Diet and exercise with or without pharmacotherapy

Behavioral: weight management program

Interventions

laparoscopic sleeve gastrectomyPROCEDURE

laparoscopic sleeve gastrectomy plus dietary and physical activity support

weight loss surgery
weight management programBEHAVIORAL

1200-1500 kcal renal diet, increased physical activity, with optional orlistat therapy at 120 mg tds for 12 months

Lifestyle Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Related Publications (1)

  • Conley MM, McFarlane CM, Johnson DW, Kelly JT, Campbell KL, MacLaughlin HL. Interventions for weight loss in people with chronic kidney disease who are overweight or obese. Cochrane Database Syst Rev. 2021 Mar 30;3(3):CD013119. doi: 10.1002/14651858.CD013119.pub2.

    PMID: 33782940DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicObesityWeight LossMotor Activity

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsBody Weight ChangesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 20, 2010

First Posted

January 21, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

June 9, 2016

Record last verified: 2010-01

Locations

GB(1)