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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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16 March 2015 |
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Main ID: |
NCT02386930 |
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Date of registration:
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07/03/2015 |
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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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Behavioral Lifestyle Intervention Study (BLIS) in Patients With Type 2 Diabetes in UAE: A Randomized Controlled Trial in Real Life Setting
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Scientific title:
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Date of first enrolment:
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July 2013 |
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Target sample size:
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35 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02386930 |
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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, 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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United Arab Emirates
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Females or males. Type 2 diabetes. BMI (kg/ m²) = 25. Age 18-60 years old. HbA1c > 7%.
Exclusion Criteria:
major physical activity disability that restricts participation in moderate physical
activity.
serious heart condition like heart failure, heart attack, stroke within the last 3 months.
participating in a weight management or lifestyle program. presence of proliferative
retinopathy or kidney failure.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes
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Intervention(s)
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Behavioral: Behvarioal lifestyle modification
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Primary Outcome(s)
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HbA1c%
[Time Frame: 6 months]
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Secondary Outcome(s)
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Lipid profile ( serum cholesterol, LDL, HDL, triglycerides)
[Time Frame: 6 months]
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Weight
[Time Frame: 6 months]
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Body composition analysis
[Time Frame: 6 months]
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carbohydrates intake in grams
[Time Frame: 6 months]
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physical exercise in minutes per day
[Time Frame: 6 months]
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Blood presssure (systolic and diastolic)
[Time Frame: 6 months]
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Secondary ID(s)
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032013-07
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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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