Lifestyle Changes in Patients With Type 2 Diabetes Mellitus and Hypertension

NCT01461330 | Terminated

• 1 other identifier: HCPA 10-0411
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Keywords

diabetes; exercise; DASH diet; ABPM

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Blood Pressure at 4 weeks

  Ambulatory Blood Pressure Monitoring (ABPM) at baseline and after 4 weeks

  4 weeks

Secondary Outcomes (1)

• Change from Baseline in glucose control at 4 weeks

  4 weeks

Study Arms (2)

DASH diet

EXPERIMENTAL

DASH DIET + EXERCISE

Other: DASH diet plus exercise

ADA DIET

ACTIVE COMPARATOR

DIET ACCORDING AMERICAN DIABETES ASSOCIATION DIETARY RECOMMENDATIONS FOR DIABETES

Other: ADA diet

Interventions

DASH diet plus exercise OTHER

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.

Also known as: LYFESTYLE INTERVENTION

DASH diet

ADA diet OTHER

Adoption of ADA diet.

Also known as: Active comparator: ADA DIET

ADA DIET

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus; Motor Activity

Interventions

Dietary Approaches To Stop Hypertension; Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Tatiana P de Paula, RD

  Hospital de Clínicas de Porto Alegre

  STUDY CHAIR

• Luciana Verzoça, MD

  Hospital de Clínicas de Porto Alegre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr., MD, Associated Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: October 28, 2011
• Study Start: February 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 26, 2017

Record last verified: 2017-01

Locations

BR (1)