|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00996294 |
|
Date of registration:
|
15/10/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Surgical Treatment of Type 2 Diabetes Mellitus in <35 Body Mass Index (BMI)
|
|
Scientific 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") |
|
Date of first enrolment:
|
November 2007 |
|
Target sample size:
|
50 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00996294 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Italy
| | | | | | | |
|
Contacts
|
|
Name:
|
Nicola Scopinaro, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Azienda Ospedaliera Universitaria "San Martino", Genova, Italy |
| | |
|
Key inclusion & exclusion 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
Age minimum:
35 Years
Age maximum:
70 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Bariatric Surgery
|
|
Gastric Bypass
|
|
Biliopancreatic Diversion
|
|
Type 2 Diabetes Mellitus
|
|
Intervention(s)
|
|
Procedure: biliopancreatic diversion, gastric bypass
|
|
Primary Outcome(s)
|
|
Diabetes control, define by FSG and HbA1c
[Time Frame: 1 year]
|
|
Secondary Outcome(s)
|
|
Diabetes control defined by FSG and HbA1c
[Time Frame: 5 years]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|