Prospective Controlled Trial on Surgical Treatment of Type 2 Diabetes Patients With BMI 25-30 by Means of Biliopancreatic Diversion

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A previous prospective study of BPD effect on type 2 diabetes patients with BMI 25-35 (DIA-CHIR) showed that T2DM is less sensitive to BPD beneficial effect in the simply overweight patients. A new prospective study was then planned with the aim to gain insight in the mechanism of action of BPD in T2DM patients in the 25-30 BMI range. Thirty patients will be submitted to BPD and compared with 10 nonoperated controls. Euglycemic-hyperinsulinemic clamp, OGTT, and mixed meal test will be performed in all subjects preoperatively, and 1 month, 1 year, and 5 years after BPD. Complete clinical and biochemical evaluations will be performed at 1, 4, 8, and 12 months, and every sixth month thereafter until the end of the fifth year.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Collaborators: Istituto Nazionale per lo Studio e la Cura dei Tumori; Santa Chiara Hospital
• Treatments: Hypoglycemic Agents

Criteria

Inclusion Criteria:

• age: 35-70 years

• diabetes duration: >5 years

• documented poor glycemic control (HbA1c =>8% despite medical treatment according to GCP)

• presence of comorbidities or complications (e.g. dyslipidemia, arterial hypertension, neuropathy, retinopathy, CVD, previous stroke or TIA, lower limb amputation)

• availability to comply with the entire follow-up

Exclusion Criteria:

• general contraindications to BPD (applies also to medical controls)

• presence of anti-islet or anti-GAD antibodies or plasma C-peptide concentration <0.5 mcg/L

• blindness

• severe concomitant medical conditions (e.g. liver cirrhosis, renal failure, collagen diseases, severe endocrinopathies)

• heart failure

• recent history (less than 12 months) of myocardial infarction, stroke or TIA

• unstable angina

• pregnancy

• previous or concomitant malignancy

• severe active inflammatory, neurologic, or cardiovascular conditions

• geographic inaccessibility

• any condition which, in the opinion of the Principal Investigator, may make risky the participation in the study or bias the results