Status:
UNKNOWN
Surgical Treatment of Type 2 Diabetes Mellitus in <35 Body Mass Index (BMI)
Lead Sponsor:
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Conditions:
Type 2 Diabetes Mellitus
Bariatric Surgery
Eligibility:
All Genders
35-70 years
Phase:
NA
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 di...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00996294
Start Date
November 1 2007
End Date
October 1 2013
Last Update
January 12 2010
Active Locations (1)
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1
Ospedale San Martino
Genova, Italy, 16132