Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
ClinicalTrials.gov Identifier:
NCT00996294
First received: October 15, 2009
Last updated: January 11, 2010
Last verified: October 2009
History of Changes
  Purpose

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 Intervention
Type 2 Diabetes Mellitus
Bariatric Surgery
Biliopancreatic Diversion
Gastric Bypass
 Procedure: biliopancreatic diversion, gastric bypass

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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")

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy:

Primary Outcome Measures:
  • Diabetes control, define by FSG and HbA1c [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Diabetes control defined by FSG and HbA1c [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: November 2007
Estimated Study Completion Date: October 2013
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Nicola Scopinaro, Azienda Ospedaliera Universitaria "San Martino", Genova, Italy
ClinicalTrials.gov Identifier: NCT00996294     History of Changes
Other Study ID Numbers: DIA-CHIR
Study First Received: October 15, 2009
Last Updated: January 11, 2010
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013