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Clinical Trials/NCT00996294
NCT00996294UnknownNot Applicable

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")

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy2 sites in 1 country50 target enrollmentStarted: November 1, 2007Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
50
Locations
2
Primary Endpoint
Diabetes control, define by FSG and HbA1c
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
35 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Diabetes control, define by FSG and HbA1c

Time Frame: 1 year

Secondary Outcomes

  • Diabetes control defined by FSG and HbA1c(5 years)

Investigators

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

Study Sites (2)

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