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

Type 2 Diabetes Mellitus Clinical Trial

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")

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00996294
• Other study ID #: DIA-CHIR
• Status: Active, not recruiting
• Phase: N/A
• First received: October 15, 2009
• Last updated: January 11, 2010
• Start date: November 2007
• Est. completion date: October 2013

Study information

• Verified date: October 2009
• Source: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: October 2013
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bariatric Surgery
• Biliopancreatic Diversion
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Gastric Bypass
• Type 2 Diabetes Mellitus

Intervention

Procedure:
• biliopancreatic diversion, gastric bypass
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 gastric bypass consists of creating a small proximal gastric pouch by division of the upper stomach, with reconstruction of the GI continuity by means of a Roux-en-Y loop

Locations

Country	Name	City	State
Italy	Ospedale San Martino	Genova

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes control, define by FSG and HbA1c		1 year	Yes
Secondary	Diabetes control defined by FSG and HbA1c		5 years	Yes