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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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12 February 2024 |
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Main ID: |
NCT02488733 |
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Date of registration:
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30/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Early Sleeve Gastrectomy In New Onset Diabetic Obese Patients
ESINODOP |
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Scientific title:
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Laparoscopic Sleeve Gastrectomy Versus Conventional Medical Therapy in Patients With Newly Diagnosed Type 2 Diabetes and Body Mass Index 30-42 Kg/m2: a Randomized Clinical Trial |
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Date of first enrolment:
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December 2015 |
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Target sample size:
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56 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02488733 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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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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Amilcare Parisi, 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 Santa Maria di Terni |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. No contraindication for laparoscopic surgery or general anaesthesia.
2. Age =20 and =65 years.
3. BMI of between 30 and 42 kg/m2.
4. Documented new diagnosis of Type 2 Diabetes Mellitus obtained according to the
following American Diabetes Association parameters: fasting blood glucose = 126 mg/dl
(7.0 mmol/l) and/or HbA1c = 6.5% and no more than 8 months from enrollment in the
study.
Exclusion Criteria:
1. Previous bariatric surgery or major abdominal surgery.
2. Patients with T2DM diagnosis treated with insulin.
3. Evidence of complications connected to diabetes at any stage (diabetic retinopathy,
diabetic nephropathy/microalbuminuria, cardiovascular disease or neuropathy).
4. Cardiovascular diseases such as ischemia / coronary artery disease, arrhythmia,
peripheral vascular diseases, congestive heart failure, history of heart attacks.
5. Kidney diseases including nephro-vascular hypertension, stenosis of the renal artery
or chronic renal insufficiency.
6. Pregnancy
7. Diagnosis of psychiatric illness (including dementia, severe depression, history of
suicide attempts) or abuse of alcohol or drugs in the previous 5 years.
Age minimum:
20 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes Mellitus
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Intervention(s)
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Drug: CMT
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Procedure: LSG
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Primary Outcome(s)
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Rate of patients achieving diabetes resolution
[Time Frame: Assessed up to 1 year after randomization]
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Secondary Outcome(s)
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Total duration of the period in complete remission
[Time Frame: Assessed at 3 and 6 years]
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Average value and changes from baseline, during the follow-up period, until the predefined time end-points of anthropometric, blood, urinary and QoL parameters.
[Time Frame: Assessed up at 6 years after randomization]
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Complications related to diabetes, or its pharmacological treatment, as well as those resulting from bariatric surgery.
[Time Frame: Assessed at 2,4 6 years after randomization]
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Rate of patients with effective weight loss (defined as % Excess Weight Loss > 50%)
[Time Frame: Assessed at 2 ,4, 6 years after randomization]
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Rate of patients achieving diabetes complete remission (American Diabetes Association criteria)
[Time Frame: assessed at 2, 3, 4, 5, and 6 years after randomization]
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Rate of patients with dyslipidemia and / or that require drug therapy for dyslipidemia
[Time Frame: Assessed at 2,4 6 years after randomization]
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Time to achievement (in days) of complete remission
[Time Frame: Assessed up at 2 years after randomization]
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Time to achievement (in days) of prolonged remission
[Time Frame: Assessed up at 6 years after randomization]
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Total duration of the period with HbA1c levels =6.5%, without active pharmacologic therapy or ongoing procedures
[Time Frame: Assessed at 3 and 6 years]
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Total duration of the time period with HbA1c = 6.0% irrespective of any active pharmacologic therapy or ongoing procedures
[Time Frame: Assessed at 3 and 6 years]
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Total duration of the period with diabetes resolution
[Time Frame: Assessed at 3 and 6 years]
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Rate of patients achieving diabetes resolution
[Time Frame: assessed at 2, 3, 4, 5 and 6 years after randomization]
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Rate of patients achieving HbA1c levels =6.5%,
[Time Frame: assessed up at 1, 2, 3, 4, 5,and 6 years after randomization]
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Rate of patients achieving prolonged remission (American Diabetes Association criteria)
[Time Frame: Assessed up at 6 years after randomization]
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Rate of patients achieving HbA1c levels =6.5%,
[Time Frame: assessed at 1, 2, 3, 4, 5,and 6 years after randomization]
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Rate of patients with hypertension and / or requiring antihypertensive therapy
[Time Frame: Assessed at 2,4, 6 years after randomization]
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Renal (onset of nephropathy or microalbuminuria), cardiovascular (defined as the occurrence of myocardial infarction, congestive heart failure or stroke), and ocular damage (development of diabetic retinopathy), and diabetes-related peripheral neuropathy
[Time Frame: Assessed at 2,4, 6 years after randomization]
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Total duration of the period with HbA1c levels =6.5% irrespective of any active pharmacologic therapy or ongoing procedures
[Time Frame: Assessed at 3 and 6 years]
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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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