Prevention of Microvascular Complications in Overweight Diabetics With Surgery or Best Medicine

NCT02011178 | Withdrawn DMC

• 1 other identifier: 2013/1530-31
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

Brief Summary

Background: Diabetic kidney disease (DKD) is chronic and often progresses to kidney failure,heart disease and premature death. Unfortunately, the best medical therapies available for DKD today are ultimately unable to prevent its progression, especially in obese patients.Surgical rerouting of food within the gut with a gastric bypass operation (RYGB), improves diabetes and some of its complications. The investigators propose to investigate whether RYGB in combination with best medical therapy in patients with DKD and obesity prevent further deterioration of kidney function over a 3 years follow up period. Study design: This is an international collaboration with leading centres in Sweden and Switzerland in which100 obese type 2 diabetic patients with established DKD will volunteer to be randomly assigned to receive best medical therapy with RYGB or best medical therapy without surgery. Participants will be 18-65 years with type 2 diabetes and impaired kidney function. Yearly measurements of kidney function will then be done over a period of 3 years as a primary outcome to determine whether differences in DKD can be detectable. The study will also examine and compare a) safety of the interventions, b) the health economic impact on direct healthcare costs and Quality of Life in patients as well as c) the value of a new marker of DKD in determining which patients are most likely to benefit from surgery. Overall the study will strengthen the evidence base guiding clinical decisions about the usefulness of RYGB as an add on therapy to best medical therapy in stopping progressive DKD in patients with obesity and diabetes.

Conditions

Diabetic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Glomerular filtration rate

  Renal function measurement by Iohexol clearance

  Three years after intervention

Secondary Outcomes (7)

• Microvascular kidney damage

  3 years after intervention

• Glycaemic control

  3 years after intervention

• peripheral nervous system function

  3 years after intervention

• autonomic nervous system function

  3 years after intervention

• diabetic eyes complications

  3 years after intervention

Other Outcomes (2)

• health economics

  from intervention and three years forward

• Quality of life score

  three years after intervention

Study Arms (2)

Optimal medical treatment and surgery

ACTIVE COMPARATOR

In the study 50 obese patients with CKD 3 andT2DM will be treated using the European Association for Study of Diabetes protocol in combination with RYGB surgery.

Procedure: Optimal medical treatment and surgery

Optimal medical treatment

OTHER

In the study 50 obese patients with CKD 3 andT2DM will be treated using the European Association for Study of Diabetes protocol

Procedure: Optimal medical treatment

Interventions

Optimal medical treatment and surgery PROCEDURE

Optimal medical treatment and surgery

Optimal medical treatment PROCEDURE

Optimal medical treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI 28 - 35 kg/m2
• Age: 18-65 years, with T2DM
• Estimated glomerular filtration rate (eGFR; by MDRD) between 30 and 60mL/min/1.73m2
• Urine albumin creatinine ratio (ACR) of at least 30mg/g (microalbuminuria) in first void urine on two separate days.

You may not qualify if:

• Type 1 diabetes or a positive GAD antibody test
• Known renal artery stenosis
• Renal impairment for reasons unrelated to diabetes
• Suspicion of glomerulonephritis as determined by urine sediment (\>10 erythrocytes/visual field)
• Post-renal obstruction diagnosed by ultrasound
• Severe retinopathy (defined as high-risk proliferative diabetic retinopathy and severe visual loss according to the "Early Treatment Diabetic Retinopathy Study Severity Scale")
• Severe DKD (CKD 4 or 5, requirement of renal replacement therapy such as dialysis or kidney transplantation)
• Severe neuropathy (peripheral neuropathy stage 3)
• Unacceptably high risk for general anesthesia
• Prior extensive intra-abdominal surgery making laparoscopy complicated
• Myocardial infarction, cerebrovascular accident, transient ischemic attack, coronary-artery bypass grafting or percutaneous transluminal coronary angioplasty within the previous 6 months
• Cardiac failure (NYHA stage \> 2)
• Pregnancy or breast feeding

Sponsors & Collaborators

• Karolinska Institutet: lead
• St. Claraspital AG: collaborator

Study Sites (2)

Ersta hospital

Stockholm, Stockholm County, 116 28, Sweden

Location

St:Claraspital

Basel, 4058, Switzerland

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Thorell Anders, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 13, 2013
• Study Start: March 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 13, 2017

Record last verified: 2017-03

Locations

SE (1); CH (1)