Clinical trial NCT00996294: Surgical Treatment of Type 2 Diabetes Mellitus in <35 Body Mass Index (BMI)
Official title: Surgical Treatment of Type 2 Diabetes Mellitus in Patients With BMI <35 kg/m2 (Italian Title: "La Terapia Chirurgica Del Diabete Mellito di Tipo 2 Nel Paziente Con BMI Inferiore a 35 kg/m2")
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Bariatric Surgery
Biliopancreatic Diversion
Gastric Bypass
Lead sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Sponsor class: OTHER
First posted: 2009-10-16
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Diabetes control, define by FSG and HbA1c
timeFrame: 1 year
Secondary outcomes:
measure: Diabetes control defined by FSG and HbA1c
timeFrame: 5 years
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Ospedale San Martino
Study officials:
affiliation: Azienda Ospedaliera Universitaria "San Martino", Genova, Italy
name: Nicola Scopinaro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scopinaro N, Adami GF, Papadia FS, Camerini G, Carlini F, Briatore L, Andraghetti G, Catalano M, Cordera R. Effects of gastric bypass on type 2 diabetes in patients with BMI 30 to 35. Obes Surg. 2014 Jul;24(7):1036-43. doi: 10.1007/s11695-014-1206-1.
citation: Scopinaro N, Adami GF, Papadia FS, Camerini G, Carlini F, Briatore L, D'Alessandro G, Parodi C, Weiss A, Andraghetti G, Catalano M, Cordera R. The effects of biliopancreatic diversion on type 2 diabetes mellitus in patients with mild obesity (BMI 30-35 kg/m2) and simple overweight (BMI 25-30 kg/m2): a prospective controlled study. Obes Surg. 2011 Jul;21(7):880-8. doi: 10.1007/s11695-011-0407-0.
citation: Scopinaro N, Adami GF, Papadia FS, Camerini G, Carlini F, Fried M, Briatore L, D'Alessandro G, Andraghetti G, Cordera R. Effects of biliopanceratic diversion on type 2 diabetes in patients with BMI 25 to 35. Ann Surg. 2011 Apr;253(4):699-703. doi: 10.1097/SLA.0b013e318203ae44.