Clinical trial NCT01461330: Lifestyle Changes in Patients With Type 2 Diabetes Mellitus and Hypertension
Official title: Lifestyle Changes in Patients With Type 2 DM and Hypertension: DASH Diet and Exercise Effects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Blood Pressure
Keywords: diabetes
exercise
DASH diet
ABPM
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2011-10-28
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

Brief summary: Data obtained in hypertensive patients without diabetes suggest that increased association of non-pharmacological treatment in patients with diabetes and hypertension may be associated with an improvement in blood pressure control. Despite the beneficial results found, is not yet known the magnitude of the effect of a DASH diet associated with the stimulus of physical activity on BP in patients with type 2 diabetes. The beneficial effects on blood pressure of an additional non-pharmacological intervention to drug therapy may have an even greater impact in patients with treatment-resistant hypertension 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 resistant to treatment.

Detailed description: 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.

Eligibility criteria: Patients

Inclusion Criteria:

* type 2 diabetes
* Blood pressure ≥140/90 mm Hg
* ABMP ≥ 135/85 mm Hg

Exclusion Criteria:

* digestive disease with malabsorption
* diabetic neuropathy with gastroparesis
* BMI ≥ 40 kg/m²

Primary outcomes:
measure: Change from Baseline in Blood Pressure at 4 weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Change from Baseline in glucose control at 4 weeks
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Tatiana P de Paula, RD
role: STUDY_CHAIR
affiliation: Hospital de Clínicas de Porto Alegre
name: Luciana Verzoça, MD
role: STUDY_CHAIR
References: