Bariatric Surgery, Biliopancreatic Diversion, Type 2 Diabetes Mellitus
Conditions
Brief 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.
Interventions
PROCEDUREbiliopancreatic diversion
biliopancreatic diversion consists of a distal gastrectomy with a long Roux-en-Y reconstruction, where the enteroenterostomy is placed 50 cm proximal to the ileocecal valve
DRUGantidiabetics
patients are treated with conventional antidiabetic drugs according to the rules of good clinical practice
Sponsors
Santa Chiara Hospital
Istituto Nazionale per lo Studio e la Cura dei Tumori
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diabetes control as defined by FSG and HbA1c | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Diabetes control as defined by FSG and HbA1c | 5 years |
| Assessment of prevalence and severity of diabetes complications | 5 years |
| Assessment of patient BMI | 5 years |
Countries
Italy
Contacts
Primary ContactNicola Scopinaro, MD
Outcome results
None listed