Status:
COMPLETED
Diet and Medical Therapy Versus Bariatric Surgery in Type 2 Diabetes
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
30-60 years
Phase:
NA
Brief Summary
It is generally held that ß-cell function is irreversibly lost already at the time the disease manifests itself and thereafter continues to decline linearly with time. Several studies, however, have d...
Detailed Description
ß-cell dysfunction and insulin resistance are the main pathophysiological defects responsible for the development of hyperglycaemia \[1\]. Both these defects predict incident diabetes in high-risk sub...
Eligibility Criteria
Inclusion
- patients with type 2 diabetes and BMI ≥35 kg.m-2
- age between 30 and 60 years
- duration of diabetes ≥ 5 years
- poor glycemic control (i.e., HbA1c ≥ 7.0%) in spite a medical antidiabetic therapy in accordance with good clinical practice (GCP)
Exclusion
- pregnancy
- medical conditions requiring acute hospitalisation
- severe diabetes complications or associated medical conditions (such as blindness, end-stage renal failure, liver cirrhosis, malignancy, chronic congestive heart failure)
- 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 judgement of the Investigator, may make risky the participation in the study or bias the results
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00888836
Start Date
April 1 2009
End Date
November 1 2011
Last Update
September 16 2019
Active Locations (1)
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1
Catholic University, Faculty of Medicine
Rome, Italy, 00168