Diabetic Kidney DiseasePROMISENCT02011178
Prevention of Microvascular Complications in Overweight Diabetics With Surgery or Best Medicine
A study testing Optimal medical treatment and surgery and Optimal medical treatment in people with Diabetic Kidney Disease, run by Karolinska Institutet at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Kidney Disease
- What is being tested?
- Optimal medical treatment and surgery and Optimal medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2014to Dec 2017
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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")
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Prevention of Microvascular Complications in Overweight Diabetics With Surgery or Best Medicine; a Prospectivee, Randomized, Multicenter Study
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.
Read more
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
- Being tested
- Optimal medical treatment and surgery, Optimal medical treatment
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal medical treatment and surgeryProcedure or surgery
Optimal medical treatmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Optimal medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular filtration rate
Renal function measurement by Iohexol clearance
Measured: Three years after intervention
Secondary outcomes (7)
Microvascular kidney damage
Microvascular kidney damage measured by Albumin/Creatinine Ratio
Measured: 3 years after intervention
Glycaemic control
HbA1c and fasting plasma glucose measurements . Five day continuous glucose monitoring
Measured: 3 years after intervention
peripheral nervous system function
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
Measured: 3 years after intervention
autonomic nervous system function
Autonomic neuropathy will be assessed with the RR intervals on ECG during deep breathing test
Measured: 3 years after intervention
diabetic eyes complications
Using retinal photos and using the International Clinical Diabetic Retinopathy Disease Severity Scale
Measured: 3 years after intervention
blood preassure
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.
Measured: 3 years after intervention
Lipids
Total cholesterol, low density lipoprotein, high density lipoprotein cholesterol and triglycerides will be measured
Measured: 3 years after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startMar 2014
- Primary completionJan 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: No subjects have been enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- St. Claraspital AG
- Responsible party
- Principal investigator, Anders Thorell, Karolinska Institutet
- Investigators
- Thorell Anders, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011178
- Sponsor's protocol ID
- 2013/1530-31
- Acronym
- PROMISE
- Status last verified
- Mar 2017
- First submitted
- 10 Dec 2013
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Microvascular Complications in Overweight Diabetics With Surgery or Best Medicine; a Prospectivee, Randomized, Multicenter Study
- ClinicalTrials.gov ID
- NCT02011178
- Acronym / sponsor ID
- PROMISE / 2013/1530-31
- Conditions
- Diabetic Kidney Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects have been enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- St. Claraspital AG
- Study start
- Mar 2014
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 13 Dec 2013 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimal medical treatment and surgery | Active comparator | Procedure: Optimal medical treatment and surgeryIn 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. |
| Optimal medical treatment | Other | Procedure: Optimal medical treatmentIn the study 50 obese patients with CKD 3 andT2DM will be treated using the European Association for Study of Diabetes protocol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • BMI 28 - 35 kg/m2
Key exclusion criteria (14 listed)
- • Type 1 diabetes or a positive GAD antibody test
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 |
|---|---|---|
| Optimal medical treatment and surgery | Procedure or surgery | Optimal medical treatment and surgery |
| Optimal medical treatment | Procedure or surgery | Optimal medical treatment |
Primary outcome
Glomerular filtration rate
Time frame: Three years after intervention
Renal function measurement by Iohexol clearance
7 secondary outcomes
Microvascular kidney damage
Time frame: 3 years after intervention
Glycaemic control
Time frame: 3 years after intervention
peripheral nervous system function
Time frame: 3 years after intervention
autonomic nervous system function
Time frame: 3 years after intervention
diabetic eyes complications
Time frame: 3 years after intervention
blood preassure
Time frame: 3 years after intervention
Lipids
Time frame: 3 years after intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
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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.
Thorell Anders, Professor principal investigator
Karolinska Institutet
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimal medical treatment and surgery and Optimal medical treatment in people with Diabetic Kidney Disease, run by Karolinska Institutet at 2 sites in 2 countries.
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 4 inclusion and 14 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: withdrawn, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden, Switzerland. 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 was withdrawn before enrolling participants, so there are no results.
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?
Glomerular filtration rate (time frame: Three years after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2017.