Lifestyle Changes in Patients With Type 2 Diabetes Mellitus and Hypertension

Not Applicable

Terminated

• Conditions: Blood Pressure
• Interventions: Other: DASH diet plus exercise; Other: ADA diet

• Registration Number: NCT01461330
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-08-03
• Study First Submitted QC: 2011-10-27
• Study First Posted: 2011-10-28
• Primary Completion: 2013-10
• Study Completion: 2013-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-25
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DASH diet	DASH diet plus exercise	DASH DIET + EXERCISE
ADA DIET	ADA diet	DIET ACCORDING AMERICAN DIABETES ASSOCIATION DIETARY RECOMMENDATIONS FOR DIABETES

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Blood Pressure at 4 weeks	4 weeks	Ambulatory Blood Pressure Monitoring (ABPM) at baseline and after 4 weeks

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in glucose control at 4 weeks	4 weeks	A1 C test at baseline and after 4 weeks

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil