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

NCT ID: NCT01053130

Last Updated: 2016-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Disease Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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weight loss surgery

laparoscopic sleeve gastrectomy

Group Type EXPERIMENTAL

laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

laparoscopic sleeve gastrectomy plus dietary and physical activity support

Lifestyle Intervention

Diet and exercise with or without pharmacotherapy

Group Type ACTIVE_COMPARATOR

weight management program

Intervention Type BEHAVIORAL

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

Interventions

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laparoscopic sleeve gastrectomy

laparoscopic sleeve gastrectomy plus dietary and physical activity support

Intervention Type PROCEDURE

weight management program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role collaborator

King's College Hospital NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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King's College Hospital NHS Foundation Trust

Locations

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King's College Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 33782940 (View on PubMed)

Other Identifiers

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09/H0806/69

Identifier Type: OTHER

Identifier Source: secondary_id

KCH1639

Identifier Type: -

Identifier Source: org_study_id

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