Chronic Kidney DiseaseNCT01053130
Weight Loss Interventions in Obese Patients With Stages 3-4 Chronic Kidney Disease: a Randomised Controlled Trial
A study testing laparoscopic sleeve gastrectomy and weight management program in people with Chronic Kidney Disease and Obesity, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Obesity
- What is being tested?
- laparoscopic sleeve gastrectomy and weight management program
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2010to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Infection or course of antibiotics within the last month
- Unwilling to consider surgical treatment
- Previous kidney transplant
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Chronic Kidney Disease, Obesity
- Being tested
- laparoscopic sleeve gastrectomy, weight management program
- Keywords
- obesity, bariatric surgery, chronic kidney disease, weight loss, exercise
- Medical subject headings
- Renal Insufficiency, Chronic, Obesity, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic sleeve gastrectomyProcedure or surgery
laparoscopic sleeve gastrectomy plus dietary and physical activity support
weight management programBehavioural
1200-1500 kcal renal diet, increased physical activity, with optional orlistat therapy at 120 mg tds for 12 months
| Study group | Role | What they receive |
|---|---|---|
| weight loss surgery | Experimental | laparoscopic sleeve gastrectomy Receives: Procedure: laparoscopic sleeve gastrectomy |
| Lifestyle Intervention | Active comparator | Diet and exercise with or without pharmacotherapy Receives: Behavioral: weight management program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured glomerular filtration rate (renal function) using the iohexol clearance method in patients with stages 3-4 chronic kidney disease
Measured: 0, 6, 12 months
Secondary outcomes (8)
Composite end point of death and cardiovascular outcomes (stroke, myocardial infarction or congestive heart failure hospitalisation)
Measured: 0, 6, 12, 24, 36 months
Quality of life and anxiety and depression assessment
Measured: 0, 6, 12, 24, 36 months
Urinary albumin to creatinine ratio and protein to creatinine ratio
Measured: 0, 6, 12, 24, 36 months
Body composition (weight, BMI, waist and hip circ, BIA)
Measured: 0, 6, 12 months
Insulin resistance (HOMA method)
Measured: 0, 6, 12 months
Serum adiponectin, leptin, IL-6, TNF-α, hs-CRP, fetuin a
Measured: 0, 6, 12 months
Urinary markers IL-6, MCP-1, IL-1β, RBP, NAG
Measured: 0, 6, 12 months
Endothelial function (flow mediated dilatation)
Measured: 0, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053130
- Sponsor's protocol ID
- KCH1639
- Other IDs
- 09/H0806/69
- Status last verified
- Jan 2010
- First submitted
- 20 Jan 2010
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33782940
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01053130
- Acronym / sponsor ID
- KCH1639
- Conditions
- Chronic Kidney Disease, Obesity
- Keywords
- obesity, bariatric surgery, chronic kidney disease, weight loss, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- Jan 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 21 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| weight loss surgery | Experimental | Procedure: laparoscopic sleeve gastrectomylaparoscopic sleeve gastrectomy |
| Lifestyle Intervention | Active comparator | Behavioral: weight management programDiet and exercise with or without pharmacotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic sleeve gastrectomylaparoscopic sleeve gastrectomy plus dietary and physical activity support | Procedure or surgery | weight loss surgery |
| weight management program1200-1500 kcal renal diet, increased physical activity, with optional orlistat therapy at 120 mg tds for 12 months | Behavioural | Lifestyle Intervention |
Primary outcome
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
8 secondary outcomes
Composite end point of death and cardiovascular outcomes (stroke, myocardial infarction or congestive heart failure hospitalisation)
Time frame: 0, 6, 12, 24, 36 months
Quality of life and anxiety and depression assessment
Time frame: 0, 6, 12, 24, 36 months
Urinary albumin to creatinine ratio and protein to creatinine ratio
Time frame: 0, 6, 12, 24, 36 months
Body composition (weight, BMI, waist and hip circ, BIA)
Time frame: 0, 6, 12 months
Insulin resistance (HOMA method)
Time frame: 0, 6, 12 months
Serum adiponectin, leptin, IL-6, TNF-α, hs-CRP, fetuin a
Time frame: 0, 6, 12 months
Urinary markers IL-6, MCP-1, IL-1β, RBP, NAG
Time frame: 0, 6, 12 months
Endothelial function (flow mediated dilatation)
Time frame: 0, 6, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
- Derived from this study: PubMed 33782940Conley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic sleeve gastrectomy and weight management program in people with Chronic Kidney Disease and Obesity, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01053130, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2016.