Surgical Treatment of Type 2 Diabetes Mellitus in <35 Body Mass Index (BMI)

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Status

Unknown

Conditions

Biliopancreatic Diversion

Gastric Bypass

Type 2 Diabetes Mellitus

Bariatric Surgery

Treatments

Procedure: biliopancreatic diversion, gastric bypass

Study type

Interventional

Funder types

Other

Identifiers

NCT00996294

DIA-CHIR

Details and patient eligibility

About

Thirty type 2 diabetic patients will be submitted to biliopancreatic diversion and 20 to gastric bypass. Subjects will be monitored during a 5 year period to assess the effects of the operations on diabetes control.

Enrollment

50 patients

Sex

All

Ages

35 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 2 diabetes mellitus
Duration of diabetes ≥ 3 years
Poor glycemic control (i.e., HbA1c ≥ 7.5%) in spite of hypoglycemic therapy in accordance with good clinical practice (GCP)

Exclusion criteria

Specific contraindication to obesity surgery or biliopancreatic diversion or gastric bypass
Pregnancy
Medical conditions requiring acute hospitalisation
Severe diabetes complications or associated medical conditions [such as blindness, end-stage renal failure (i.e. serum creatinine >2 mg/dl), liver cirrhosis, malignancy, chronic congestive heart failure (NYHA class III and IV)]
Recent (within preceding 12 months) myocardial infarction, stroke or TIA
Unstable angina pectoris
Psychological conditions which may hamper patient's cooperation
Geographic inaccessibility
Any condition which, in the judgment of the Investigator, may make risky the participation in the study or bias the results