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| ID | Type | Description | Link |
|---|---|---|---|
| 09/H0806/69 | Other Identifier | UK Research Ethics Committee registration |
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| Name | Class |
|---|---|
| King's College London | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| weight loss surgery | Experimental | laparoscopic sleeve gastrectomy |
|
| Lifestyle Intervention | Active Comparator | Diet and exercise with or without pharmacotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic sleeve gastrectomy | Procedure | laparoscopic sleeve gastrectomy plus dietary and physical activity support |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measured glomerular filtration rate (renal function) using the iohexol clearance method in patients with stages 3-4 chronic kidney disease | 0, 6, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College Hospital | London | SE5 9RS | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33782940 | Derived | 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. |
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| weight management program | Behavioral | 1200-1500 kcal renal diet, increased physical activity, with optional orlistat therapy at 120 mg tds for 12 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 |
| Serum adiponectin, leptin, IL-6, TNF-α, hs-CRP, fetuin a | 0, 6, 12 months |
| Urinary markers IL-6, MCP-1, IL-1β, RBP, NAG | 0, 6, 12 months |
| Endothelial function (flow mediated dilatation) | 0, 6, 12 months |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D009765 | Obesity |
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |
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