Lifestyle Changes in Patients With Type 2 Diabetes Mellitus and Hypertension

Blood Pressure Clinical Trial

Official title:

Lifestyle Changes in Patients With Type 2 DM and Hypertension: DASH Diet and Exercise Effects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01461330
• Other study ID #: HCPA 10-0411
• Status: Terminated
• Phase: N/A
• First received: August 3, 2011
• Last updated: January 25, 2017
• Start date: February 2011
• Est. completion date: November 2013

Study information

• Verified date: January 2017
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension

Intervention

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.
• ADA diet
Adoption of ADA diet.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Blood Pressure at 4 weeks	Ambulatory Blood Pressure Monitoring (ABPM) at baseline and after 4 weeks	4 weeks
Secondary	Change from Baseline in glucose control at 4 weeks	A1 C test at baseline and after 4 weeks	4 weeks