Lifestyle Changes in Patients With Type 2 Diabetes Mellitus and Hypertension

Hospital de Clinicas de Porto Alegre

Status: Terminated

Conditions: Blood Pressure

Treatments: Other: DASH diet plus exercise; Other: ADA diet

Study type: Interventional

Funder types: Other

Identifiers

NCT01461330

HCPA 10-0411

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

DASH diet

Experimental group

Description:

DASH DIET + EXERCISE

Treatment:

Other: DASH diet plus exercise

ADA DIET

Active Comparator group

Description:

DIET ACCORDING AMERICAN DIABETES ASSOCIATION DIETARY RECOMMENDATIONS FOR DIABETES

Treatment:

Other: ADA diet