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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Karolinska Institutet
Sponsor:
Collaborator:
St. Claraspital AG
Information provided by (Responsible Party):
Anders Thorell, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT02011178
First received: December 10, 2013
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Diabetic Kidney Disease
Procedure: Optimal medical treatment and surgery
Procedure: Optimal medical treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prevention of Microvascular Complications in Overweight Diabetics With Surgery or Best Medicine; a Prospectivee, Randomized, Multicenter Study

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Glomerular filtration rate [ Time Frame: Three years after intervention ] [ Designated as safety issue: Yes ]
    Renal function measurement by Iohexol clearance


Secondary Outcome Measures:
  • Microvascular kidney damage [ Time Frame: 3 years after intervention ] [ Designated as safety issue: Yes ]
    Microvascular kidney damage measured by Albumin/Creatinine Ratio

  • Glycaemic control [ Time Frame: 3 years after intervention ] [ Designated as safety issue: Yes ]
    HbA1c and fasting plasma glucose measurements . Five day continuous glucose monitoring

  • peripheral nervous system function [ Time Frame: 3 years after intervention ] [ Designated as safety issue: Yes ]
    Michigan Neuropathy Screening Instrument (MNSI) score, which includes two separate assessments: a lower extremity examination that includes inspection of the feet to identify deformities, dry skin, calluses, infection, fissure, or ulcers, and assessment of vibratory sensation and ankle reflexes

  • autonomic nervous system function [ Time Frame: 3 years after intervention ] [ Designated as safety issue: No ]
    Autonomic neuropathy will be assessed with the RR intervals on ECG during deep breathing test

  • diabetic eyes complications [ Time Frame: 3 years after intervention ] [ Designated as safety issue: Yes ]
    Using retinal photos and using the International Clinical Diabetic Retinopathy Disease Severity Scale

  • blood preassure [ Time Frame: 3 years after intervention ] [ Designated as safety issue: Yes ]
    Blood pressure will be recorded with calibrated and validated electronic blood pressure equipment and appropriate sized cuff. Patients will sit in a chair in a quiet room for 5 minutes.

  • Lipids [ Time Frame: 3 years after intervention ] [ Designated as safety issue: Yes ]
    Total cholesterol, low density lipoprotein, high density lipoprotein cholesterol and triglycerides will be measured


Other Outcome Measures:
  • health economics [ Time Frame: from intervention and three years forward ] [ Designated as safety issue: No ]
    Direct healthcare resource consumption. Costs to Governments or Insurance companies plus private expenditure on health. Costs will include primary and secondary surgery, medication, laboratory tests, health provider reimbursement, private prescription charges and co-payments for medications

  • Quality of life score [ Time Frame: three years after intervention ] [ Designated as safety issue: No ]
    Quality of life will be measured by the general health 36-item Health Survey (SF-36)


Estimated Enrollment: 100
Study Start Date: March 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Optimal medical treatment and surgery
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • 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.

Exclusion Criteria:

  • • 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)
    • Inability to stop smoking prior to inclusion
    • Pregnancy or breast feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02011178

Contacts
Contact: Anders Thorell, Professor +46 8 714 6541 ext 6541 anders.thorell@erstadiakoni.se

Locations
Sweden
Ersta hospital Recruiting
Stockholm, Sweden, 116 28
Contact: Anders Thorell, Professor    +46 8 714 6541 ext 6541    anders.thorell@erstadiakoni.se   
Principal Investigator: Anders Thorell, Professor         
Switzerland
St:Claraspital Not yet recruiting
Basel, Switzerland, 4058
Contact: Ralph Peterli, MD, PhD    +41 (0) 61685 8484    ralph.peterli@claraspital.ch   
Sub-Investigator: Ralph Peterli, MD, PhD         
Sponsors and Collaborators
Karolinska Institutet
St. Claraspital AG
Investigators
Principal Investigator: Thorell Anders, Professor Karolinska Institutet
  More Information

No publications provided

Responsible Party: Anders Thorell, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02011178     History of Changes
Other Study ID Numbers: 2013/1530-31
Study First Received: December 10, 2013
Last Updated: March 11, 2014
Health Authority: Sweden: The National Board of Health and Welfare

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Overweight
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014