Clinical trial NCT01046994: Prospective Controlled Trial on Surgical Treatment of Type 2 Diabetes Patients With BMI 25-30 by Means of Biliopancreatic Diversion
Official title: Prospective Controlled Trial on Surgical Treatment of Type 2 Diabetes Patients With BMI 25-30 by Means of Biliopancreatic Diversion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Bariatric Surgery
Biliopancreatic Diversion
Lead sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Sponsor class: OTHER
Collaborators: name: Santa Chiara Hospital
name: Istituto Nazionale per lo Studio e la Cura dei Tumori
First posted: 2010-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Diabetes control as defined by FSG and HbA1c
timeFrame: 1 year
Secondary outcomes:
measure: Diabetes control as defined by FSG and HbA1c
timeFrame: 5 years
measure: Assessment of prevalence and severity of diabetes complications
timeFrame: 5 years
measure: Assessment of patient BMI
timeFrame: 5 years
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Ospedale San Martino
Study officials:
References: