Change of Lifestyle in Elderly Patients With Type 2 Diabetes and Systemic Arterial Hypertension

NCT04863755 | Completed

• 1 other identifier: 2017-0086
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the effect of lifestyle modification through the adoption of a DASH diet, with and without physical activity guidance, on blood pressure and insulin sensitivity in elderly patients with type 2 diabetes and hypertension.

Conditions

Diabetes; Hypertension

Keywords

Diabetes; Hypertension; Elderly; DASH; Steps

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Blood Pressure at 4 months

  24 hours ambulatory blood pressure monitoring (ABPM)

  Baseline and 4 months

Secondary Outcomes (11)

• Change from Baseline Insulin Sensitivity at 4 months

  Baseline and 4 months

• Change from Baseline Glucose Profile at 4 months

  Baseline and 4 months

• Change from Baseline Weight at 4 months anthropometric variables

  Baseline and 4 months

• Change from Baseline BMI at 4 months

  Baseline and 4 months

• Change from Baseline Skeletal muscle mass at 4 months

  Baseline and 4 months

Study Arms (2)

DASH diet only

OTHER

Patients receive a DASH diet and orientation to maintain their physical activity

Behavioral: DASH

DASH diet with pedometer

OTHER

Patients receive a DASH diet and orientation to increase their physical activity with a pedometer steps count

Behavioral: DASHPED

Interventions

DASH BEHAVIORAL

Patients receive DASH diet orientation and recommended to maintain their usual physical activity

DASH diet only

DASHPED BEHAVIORAL

Patients receive DASH diet orientation and recommended to increase their usual activity with the use of a pedometer

DASH diet with pedometer

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 60 years or more
• Diabetes Mellitus
• Hypertension with poor control

You may not qualify if:

• Glucocorticoid use
• Unstable angina
• Acute myocardial infarction in the last 6 months
• Heart failure classes III and IV
• history of cirrhosis, alcoholism or use of illicit drugs
• Dementia and malignant disease that compromises survival in 5 years
• Serum creatinine greater than 2, 0mg / dl
• BMI\> 40 kg / m²
• Physical disability that prevents the use of a pedometer
• Participating in another research project involving any type of intervention.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Federal University of Health Science of Porto Alegre: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Luciana Verçoza Viana

  Hospital de Clínicas de Porto Alegre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 28, 2021
• Study Start: May 9, 2017
• Primary Completion: March 18, 2020
• Study Completion: March 18, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)