Lifestyle Changes in Patients With Type 2 Diabetes Mellitus and Hypertension
NCT ID: NCT01461330
Last Updated: 2017-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
40 participants
INTERVENTIONAL
2011-02-28
2013-11-30
Brief Summary
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Detailed Description
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Forty type 2 diabetic with resistant hypertension outpatients were included in a randomized clinical trial: treatment 1- DASH diet + encouragement for physical activity through use of pedometer; treatment 2- ADA diet + usual exercises. The duration of each treatment are four weeks. The patients included should have performed Ambulatory Blood Pressure Monitoring (ABPM) to exclude white-coat effect, ie when there are abnormal in the measurement of office blood pressure (equal to or above 140/90 mm Hg) and normal blood pressure by ABPM during the awake period (equal to or below 135/85 mm Hg). Twenty-four hour records with concurrent 24h urinary collections (protein intake estimative), clinical and laboratory evaluation were performed at baseline and after 4 weeks. Serum fatty acids were measured in total lipids by gas chromatography.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
active comparator = ADA diet = Adoption of ADA diet.
PREVENTION
NONE
Study Groups
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DASH diet
DASH DIET + EXERCISE
DASH diet plus exercise
DASH diet adapted to the usual diet of Brazilian type 2 diabetic patients = prescription of a normocaloric diet including fruits, vegetables, grain products, low fat dairy foods, legumes, without sugar, and with limited fat
Exercises: the recommended physical activity will consist of using a pedometer during the experimental period.
ADA DIET
DIET ACCORDING AMERICAN DIABETES ASSOCIATION DIETARY RECOMMENDATIONS FOR DIABETES
ADA diet
Adoption of ADA diet.
Interventions
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DASH diet plus exercise
DASH diet adapted to the usual diet of Brazilian type 2 diabetic patients = prescription of a normocaloric diet including fruits, vegetables, grain products, low fat dairy foods, legumes, without sugar, and with limited fat
Exercises: the recommended physical activity will consist of using a pedometer during the experimental period.
ADA diet
Adoption of ADA diet.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Blood pressure ≥140/90 mm Hg
* ABMP ≥ 135/85 mm Hg
Exclusion Criteria
* diabetic neuropathy with gastroparesis
* BMI ≥ 40 kg/m²
30 Years
90 Years
ALL
No
Sponsors
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Hospital de Clinicas de Porto Alegre
OTHER
Responsible Party
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Mirela Jobim de Azevedo
Dr., MD, Associated Professor of Medicine
Principal Investigators
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Tatiana P de Paula, RD
Role: STUDY_CHAIR
Hospital de Clínicas de Porto Alegre
Luciana Verzoça, MD
Role: STUDY_CHAIR
Hospital de Clínicas de Porto Alegre
Locations
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Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Other Identifiers
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HCPA 10-0411
Identifier Type: -
Identifier Source: org_study_id
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