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

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ClinicalTrials.gov Identifier: NCT00996294
Recruitment Status : Unknown
Verified October 2009 by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.
Recruitment status was:  Active, not recruiting
First Posted : October 16, 2009
Last Update Posted : January 12, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Bariatric Surgery Biliopancreatic Diversion Gastric Bypass Procedure: biliopancreatic diversion, gastric bypass

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2007
Primary Completion Date : October 2009
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: surgery
patients will be submitted to biliopancreatic diversion or gastric bypass
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



Primary Outcome Measures :
  1. Diabetes control, define by FSG and HbA1c [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Diabetes control defined by FSG and HbA1c [ Time Frame: 5 years ]


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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996294


Locations
Italy
Ospedale San Martino
Genova, Italy, 16132
Sponsors and Collaborators
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Investigators
Principal Investigator: Nicola Scopinaro, MD Azienda Ospedaliera Universitaria "San Martino", Genova, Italy