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
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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COMPLETED
NA
16 participants
INTERVENTIONAL
2010-01-31
2013-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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weight loss surgery
laparoscopic sleeve gastrectomy
laparoscopic sleeve gastrectomy
laparoscopic sleeve gastrectomy plus dietary and physical activity support
Lifestyle Intervention
Diet and exercise with or without pharmacotherapy
weight management program
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
weight management program
1200-1500 kcal renal diet, increased physical activity, with optional orlistat therapy at 120 mg tds for 12 months
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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King's College London
OTHER
King's College Hospital NHS Trust
OTHER
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
Countries
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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.
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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