ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Mirela Jobim de Azevedo, 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.

Condition or disease Intervention/treatment Phase
Blood Pressure Other: DASH diet plus exercise Other: ADA diet Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
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)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change from Baseline in Blood Pressure at 4 weeks [ Time Frame: 4 weeks ]
    Ambulatory Blood Pressure Monitoring (ABPM) at baseline and after 4 weeks


Secondary Outcome Measures :
  1. Change from Baseline in glucose control at 4 weeks [ Time Frame: 4 weeks ]
    A1 C test at baseline and after 4 weeks



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Study Chair: Tatiana P de Paula, RD Hospital de Clínicas de Porto Alegre
Study Chair: Luciana Verzoça, MD Hospital de Clínicas de Porto Alegre

Responsible Party: Mirela Jobim de Azevedo, Dr., MD, Associated Professor of Medicine, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01461330     History of Changes
Other Study ID Numbers: HCPA 10-0411
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017

Keywords provided by Mirela Jobim de Azevedo, Hospital de Clinicas de Porto Alegre:
diabetes
exercise
DASH diet
ABPM

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases