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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01041768 |
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Date of registration:
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31/12/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Multicentric Prospective Randomized Trial on Surgery Versus Standard Medical Care in Type 2 Diabetic Patients BMI 30-35
DIA-CHIR-MULT |
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Scientific title:
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Multicentric Prospective Randomized Controlled Trial on the Effect of Gastric Bypass and Bilopancreatic Diversion on Type 2 Diabetes Mellitus in Patients With BMI Between 30 and 35 |
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Date of first enrolment:
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March 2009 |
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Target sample size:
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300 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01041768 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Nicola Scopinaro, MD |
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Address:
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Telephone:
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+39 010 3537301 |
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Email:
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nicola.scopinaro@unige.it |
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Affiliation:
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Name:
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Nicola Scopinaro, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Azienda Ospedaliera Universitaria "San Martino", Genova, Italy |
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Name:
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Nicola Scopinaro, MD |
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Address:
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Telephone:
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+39 010 3537301 |
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Email:
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nicola.scopinaro@unige.it |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- BMI =30 and =34.9 kg/m2
- age between 35 and 70 years
- duration of diabetes = 5 years
- poor glycemic control (i.e., HbA1c = 8%) in spite a medical antidiabetic therapy in
accordance with good clinical practice (GCP)
- presence of significant co-morbidities or complications (such as dyslipidemia,
arterial hypertension, impaired renal function, neuropathy, retinopathy, CVD)
Exclusion Criteria:
- specific contraindication to obesity surgery or GBP or BPD, including any gastric
alteration specifically contraindicating GBP
- HbA1c < 8%
- positive autoantibodies anti-pancreas islet
- serum C-peptide < 0.5 ng/ml
- 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
Age minimum:
35 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus
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Intervention(s)
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Procedure: Bariatric surgery
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Primary Outcome(s)
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Proportion of patients achieving diabetes complete remission (HbA1c 6% or below) or diabetes control (HbA1c between 7% and 6.1%) on free diet and with no antidiabetic medical therapy.
[Time Frame: year 1, 3, 5]
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Secondary Outcome(s)
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Stable reduction of preoperative HbA1c; BMI; mortality/morbidity; Major components of the metabolic syndrome; Diabetes complications; Improvement of beta-cell function; insulin resistance reduction ; Overall and CV disease mortality.
[Time Frame: at and post surgery, 1,3, 5 years since randomization]
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Secondary ID(s)
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DIA-CHIR-MULT-BMI 30-35
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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