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

NCT01353066 | Unknown Phase 2

• 1 other identifier: HCB-UOM-012011
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atherosclerotic Cardiovascular Disease; Subclinical Disease and/or Syndrome

Keywords

Type 2 Diabetes Mellitus; BMI 30.0-34.9 kg/m2

Outcome Measures

Primary Outcomes (1)

• Measurement of the progression carotid intima media thickness (CIMT) at 24 months after entry into the trial relative to baseline

  24 months

Study Arms (2)

Intensive Medical Treatment

ACTIVE COMPARATOR

Drug: Intensive Medical Treatment

Intensive medical treatment (IMM)+RYGBP

EXPERIMENTAL

Other: IMM+Roux-en-Y Gastric Bypass (RYGBP)

Interventions

Intensive Medical Treatment DRUG

Intensive Medical Treatment

IMM+Roux-en-Y Gastric Bypass (RYGBP) OTHER

Intensive medical treatment (IMM)+RYGBP

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

MeSH Terms

Conditions

Atherosclerosis; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Antonio M Lacy, MD

CONTACT

+34932279854; steres@clinic.ub.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: May 12, 2011
• Last Updated: May 12, 2011

Record last verified: 2011-05

Locations

ES (1)