Gastric Bypass Versus Best Medical Treatment on Progression of Carotid-intima Media Thickness in Type 2 Diabetes Mellitus (T2DM) (EURDSS)

May 11, 2011 updated by: Hospital Clinic of Barcelona

Multicenter Randomized Prospective Trial on the Effects of Intensive Medical Treatment of Type 2 Diabetes With and Without Roux-in-Y Gastric Bypass Surgery on Carotid Intima Media Thickness in Grade I Obesity (BMI 30,0-34,9 kg/m2)

Background: Type 2 Diabetes Mellitus (T2DM) is associated with an increased burden for cardiovascular disease (CVD). Multifactorial interventions are necessary to reduce the CV risk in T2DM. Bariatric surgery appears to be an alternative for the multifactorial intervention in T2DM associated with obesity. Data have shown, that clinical trial aiming at the control of CVRF in T2DM may not translate in the reduction of CV events.

Hypothesis: Intensive medical treatment (IMM) including Roux-en-Y Gastric Bypass (RYGBP) could be superior in the control of the progression of subclinical atherosclerotic disease, as evaluated by carotid ultrasound, in subjects with T2DM and a BMI between 30.0 and 34.9 kg/m2.The primary aim of the study is To compare the effects of intensive medical treatment (IMM) including Roux-en-Y Gastric Bypass (RYGBP) and IMM alone on the progression of the carotid intima media thickness (CIMT) at 24 months after entry into the trial relative to baseline.Methodology: Two-year Randomized Clinical Trial, including 240 patients

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalunya
      • Barcelona, Catalunya, Spain, 08036
        • Hospital Clinic De Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 35 to 65 years at eligibility visit.
  • Diagnosed with T2DM at least 6 months prior to enrollment, under the active care of a doctor for at least he six months prior to enrollment, and HbA 1c > 7.0 %.
  • Current treatment for T2DM consisting of multiple doses of insulin with/without hypoglycemic agents or hypoglycemic agents plus basal insulin.
  • Optimization of diabetes medical treatment prior to inclusion in the study would have been performed based on best medical practices.
  • Body Mass Index (BMI)> 30.0 kg/m2 and <34.9 kg/m2 at eligibility visit.
  • Willingness to accept random assignment to either treatment group.
  • Expect to live or work within approximately one hour's traveling time from the study clinic for the duration of the two-year trial.
  • Willingness to comply with the follow-up protocol and successful completion of the run-in.
  • Written informed consent.

Exclusion Criteria:

  • Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
  • Current evidence of congestive heart failure (grade II or IV), angina pectoris, symptomatic peripheral vascular disease or advanced cardiovascular disease.
  • History of severe hypoglycemic episodes associated with medical treatment of type 2 DM
  • Cardiac stress test indicating that surgery would not be safe
  • Pulmonary embolus or thrombophlebitis in the past six months.
  • Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years.
  • Significant anemia or history of coagulopathy.
  • Serum creatinine >1.5 mg/dl.
  • Serum total bilirubin or alkaline phosphatase greater than the upper limit of normal, or ALT greater than twice the upper limit of normal.
  • History of previous surgery contraindicating gastric bypass at the criteria of the surgical team.
  • Gastric or duodenal ulcer in the past six months.
  • History of intra-abdominal sepsis (except for uncomplicated appendicitis or diverticulitis more than six months prior to enrollment).
  • Previous organ transplantation.
  • Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease.
  • Currently pregnant or nursing, or planning to become pregnant in the next two years.
  • History of alcohol or drug dependency (excluding caffeine and nicotine) in the past five years
  • Active psychosocial or psychiatric problem that is likely to interferer with adherence to the protocol.
  • Score of 17 or higher on the CES-D (depression scale).
  • Current participation in a conflicting research protocol.
  • Presence of any chronic or debilitating disease that would make adherence to the protocol difficult.
  • 12-lead EKG indicating that surgery or intensive medical treatment would not be safe.
  • Diagnosed with diabetes more than 15 years ago.
  • Positive GAD antibodies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intensive Medical Treatment
Drug: Intensive Medical Treatment
Experimental: Intensive medical treatment (IMM)+RYGBP
Other: IMM+Roux-en-Y Gastric Bypass (RYGBP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of the progression carotid intima media thickness (CIMT) at 24 months after entry into the trial relative to baseline
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 11, 2011

First Submitted That Met QC Criteria

May 11, 2011

First Posted (Estimate)

May 12, 2011

Study Record Updates

Last Update Posted (Estimate)

May 12, 2011

Last Update Submitted That Met QC Criteria

May 11, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB-UOM-012011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atherosclerotic Cardiovascular Disease

Clinical Trials on Intensive Medical Treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe