Lifestyle Changes in Patients With Type 2 Diabetes Mellitus and Hypertension
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01461330|
Recruitment Status : Terminated
First Posted : October 28, 2011
Last Update Posted : January 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Blood Pressure||Other: DASH diet plus exercise Other: ADA diet||Not Applicable|
The aim of this study is to evaluate the effect of changes in lifestyle on blood pressure in patients with type 2 diabetes and hypertension. Secondary objectives are: Assess whether the prescription of a DASH-type diet and encouragement for physical activity through use of pedometers, can improve blood pressure control in patients with type 2 diabetes and hypertension resistant to treatment.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
intervention: 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.
active comparator = ADA diet = Adoption of ADA diet.
|Masking:||None (Open Label)|
|Official Title:||Lifestyle Changes in Patients With Type 2 DM and Hypertension: DASH Diet and Exercise Effects|
|Actual Study Start Date :||February 2011|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||November 2013|
Experimental: DASH diet
DASH DIET + EXERCISE
Other: 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.
Other Name: LYFESTYLE INTERVENTION
Active Comparator: ADA DIET
DIET ACCORDING AMERICAN DIABETES ASSOCIATION DIETARY RECOMMENDATIONS FOR DIABETES
Other: ADA diet
Adoption of ADA diet.
Other Name: Active comparator: ADA DIET
- Change from Baseline in Blood Pressure at 4 weeks [ Time Frame: 4 weeks ]Ambulatory Blood Pressure Monitoring (ABPM) at baseline and after 4 weeks
- Change from Baseline in glucose control at 4 weeks [ Time Frame: 4 weeks ]A1 C test at baseline and after 4 weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461330
|Hospital de Clínicas de Porto Alegre|
|Porto Alegre, Rio Grande do Sul, Brazil|
|Study Chair:||Tatiana P de Paula, RD||Hospital de Clínicas de Porto Alegre|
|Study Chair:||Luciana Verzoça, MD||Hospital de Clínicas de Porto Alegre|