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

Primary Purpose

Type 2 Diabetes Mellitus, Bariatric Surgery, Biliopancreatic Diversion

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
biliopancreatic diversion, gastric bypass
Sponsored by
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale San Martino

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

surgery

Arm Description

patients will be submitted to biliopancreatic diversion or gastric bypass

Outcomes

Primary Outcome Measures

Diabetes control, define by FSG and HbA1c

Secondary Outcome Measures

Diabetes control defined by FSG and HbA1c

Full Information

First Posted
October 15, 2009
Last Updated
January 11, 2010
Sponsor
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT00996294
Brief Title
Surgical Treatment of Type 2 Diabetes Mellitus in <35 Body Mass Index (BMI)
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 Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Bariatric Surgery, Biliopancreatic Diversion, Gastric Bypass

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
surgery
Arm Type
Experimental
Arm Description
patients will be submitted to biliopancreatic diversion or gastric bypass
Intervention Type
Procedure
Intervention Name(s)
biliopancreatic diversion, gastric bypass
Intervention Description
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 Measure Information:
Title
Diabetes control, define by FSG and HbA1c
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Diabetes control defined by FSG and HbA1c
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola Scopinaro, MD
Organizational Affiliation
Azienda Ospedaliera Universitaria "San Martino", Genova, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
24647849
Citation
Scopinaro N, Adami GF, Papadia FS, Camerini G, Carlini F, Briatore L, Andraghetti G, Catalano M, Cordera R. Effects of gastric bypass on type 2 diabetes in patients with BMI 30 to 35. Obes Surg. 2014 Jul;24(7):1036-43. doi: 10.1007/s11695-014-1206-1.
Results Reference
derived
PubMed Identifier
21541815
Citation
Scopinaro N, Adami GF, Papadia FS, Camerini G, Carlini F, Briatore L, D'Alessandro G, Parodi C, Weiss A, Andraghetti G, Catalano M, Cordera R. The effects of biliopancreatic diversion on type 2 diabetes mellitus in patients with mild obesity (BMI 30-35 kg/m2) and simple overweight (BMI 25-30 kg/m2): a prospective controlled study. Obes Surg. 2011 Jul;21(7):880-8. doi: 10.1007/s11695-011-0407-0.
Results Reference
derived
PubMed Identifier
21475009
Citation
Scopinaro N, Adami GF, Papadia FS, Camerini G, Carlini F, Fried M, Briatore L, D'Alessandro G, Andraghetti G, Cordera R. Effects of biliopanceratic diversion on type 2 diabetes in patients with BMI 25 to 35. Ann Surg. 2011 Apr;253(4):699-703. doi: 10.1097/SLA.0b013e318203ae44.
Results Reference
derived

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

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