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

Not Applicable

• Conditions: Type 2 Diabetes Mellitus; Bariatric Surgery; Biliopancreatic Diversion; Gastric Bypass
• Interventions: Procedure: biliopancreatic diversion, gastric bypass

• Registration Number: NCT00996294
• Lead Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Status Verified: 2009-10
• Primary Completion: 2009-10
• Study First Submitted: 2009-10-15
• Study First Submitted QC: 2009-10-15
• Study First Posted: 2009-10-16
• Last Update Submitted: 2010-01-11
• Last Update Posted: 2010-01-12
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
surgery	biliopancreatic diversion, gastric bypass	patients will be submitted to biliopancreatic diversion or gastric bypass

Primary Outcome Measures

Name	Time	Method
Diabetes control, define by FSG and HbA1c	1 year

Secondary Outcome Measures

Name	Time	Method
Diabetes control defined by FSG and HbA1c	5 years

Trial Locations

Locations (1)

Ospedale San Martino; 🇮🇹 Genova, Italy