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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02011178
Recruitment Status : Withdrawn (No subjects have been enrolled)
First Posted : December 13, 2013
Last Update Posted : March 13, 2017
St. Claraspital AG
Information provided by (Responsible Party):
Anders Thorell, Karolinska Institutet

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention of Microvascular Complications in Overweight Diabetics With Surgery or Best Medicine; a Prospectivee, Randomized, Multicenter Study
Study Start Date : March 2014
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Glomerular filtration rate [ Time Frame: Three years after intervention ]
    Renal function measurement by Iohexol clearance

Secondary Outcome Measures :
  1. Microvascular kidney damage [ Time Frame: 3 years after intervention ]
    Microvascular kidney damage measured by Albumin/Creatinine Ratio

  2. Glycaemic control [ Time Frame: 3 years after intervention ]
    HbA1c and fasting plasma glucose measurements . Five day continuous glucose monitoring

  3. peripheral nervous system function [ Time Frame: 3 years after intervention ]
    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

  4. autonomic nervous system function [ Time Frame: 3 years after intervention ]
    Autonomic neuropathy will be assessed with the RR intervals on ECG during deep breathing test

  5. diabetic eyes complications [ Time Frame: 3 years after intervention ]
    Using retinal photos and using the International Clinical Diabetic Retinopathy Disease Severity Scale

  6. blood preassure [ Time Frame: 3 years after intervention ]
    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.

  7. Lipids [ Time Frame: 3 years after intervention ]
    Total cholesterol, low density lipoprotein, high density lipoprotein cholesterol and triglycerides will be measured

Other Outcome Measures:
  1. health economics [ Time Frame: from intervention and three years forward ]
    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

  2. Quality of life score [ Time Frame: three years after intervention ]
    Quality of life will be measured by the general health 36-item Health Survey (SF-36)

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02011178

Ersta hospital
Stockholm, Sweden, 116 28
Basel, Switzerland, 4058
Sponsors and Collaborators
Karolinska Institutet
St. Claraspital AG
Principal Investigator: Thorell Anders, Professor Karolinska Institutet

Responsible Party: Anders Thorell, Professor, Karolinska Institutet Identifier: NCT02011178     History of Changes
Other Study ID Numbers: 2013/1530-31
First Posted: December 13, 2013    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017

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