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

NCT ID: NCT04863755

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-09
• Study Completion Date: 2020-03-18

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.

Detailed Description

Data regarding the effects of physical activity and DASH-type diet on blood pressure control in patients with type 2 diabetes and hypertension are scarce in the literature, whether evaluating these isolated interventions or together. In addition, most studies do not measure BP using ABPM, which has a special importance in the assessment of pressure homeostasis in DM or are short-term studies. Were only two studies have been identified in the literature that evaluated the effect of the DASH diet on patients with type 2 DM; however, in both trials, being elderly was not an inclusion criterion. The first was an Iranian study that demonstrated in 31 non-hypertensive patients a significant reduction in BP after 8 weeks of following a DASH diet. In the second ECR, we demonstrated that in 20 hypertensive type 2 DM patients, all using antihypertensive drugs and with uncontrolled BP, a DASH-type diet for 4 weeks associated with physical activity reduced the systolic BP assessed by ABPM by 12.5 mmHg. However, the adopted design did not allow to separate the effect of diet from the effect of physical activity. On the other hand, the effect of a single session of walking followed by a 24-hour ABPM assessment showed a reduction in BP in hypertensive elderly and non-hypertensive patients, also without DM. So far it is not defined in patients with type 2 DM and hypertension, especially the elderly, whether the DASH diet alone is as beneficial for BP as its association with physical activity, particularly, considering the difficulties of performing exercises in this group of patients. This is valuable information, as it would reinforce the role of diet therapy intervention even if in isolation in this age group. Furthermore, the role of the DASH diet with or without physical activity remains unknown on insulin sensitivity.

Conditions

Diabetes; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

DASH diet only

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

Group Type: OTHER

DASH

Intervention Type: BEHAVIORAL

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

DASH diet with pedometer

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

Group Type: OTHER

DASHPED

Intervention Type: BEHAVIORAL

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

Interventions

DASH

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

Intervention Type: BEHAVIORAL

DASHPED

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role: collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luciana Verçoza Viana

Role: STUDY_DIRECTOR

Hospital de Clínicas de Porto Alegre

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

2017-0086

Identifier Type: -

Identifier Source: org_study_id