Clinical trial NCT04863755: Change of Lifestyle in Elderly Patients With Type 2 Diabetes and Systemic Arterial Hypertension
Official title: Change of Lifestyle in Elderly Patients With Type 2 Diabetes and Systemic Arterial Hypertension: Effects of DASH Diet and Physical Activity on Blood Pressure and Insulin Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hypertension
Keywords: Diabetes
Hypertension
Elderly
DASH
Steps
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Health Science of Porto Alegre
First posted: 2021-04-28
Enrollment: 37
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Change from Baseline Blood Pressure at 4 months
timeFrame: Baseline and 4 months
Secondary outcomes:
measure: Change from Baseline Insulin Sensitivity at 4 months
timeFrame: Baseline and 4 months
measure: Change from Baseline Glucose Profile at 4 months
timeFrame: Baseline and 4 months
measure: Change from Baseline Weight at 4 months anthropometric variables
timeFrame: Baseline and 4 months
measure: Change from Baseline BMI at 4 months
timeFrame: Baseline and 4 months
measure: Change from Baseline Skeletal muscle mass at 4 months
timeFrame: Baseline and 4 months
measure: Change from Baseline Body fat mass at 4 months
timeFrame: Baseline and 4 months
measure: Change from Baseline Percent body Fat at 4 months
timeFrame: Baseline and 4 months
measure: Change from Baseline Total cholesterol at 4 months
timeFrame: Baseline and 4 months
measure: Change from Baseline LDL cholesterol at 4 months
timeFrame: Baseline and 4 months
measure: Change from Baseline Triglycerides at 4 months
timeFrame: Baseline and 4 months
measure: Change from Baseline HDL cholesterol at 4 months
timeFrame: Baseline and 4 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Luciana Verçoza Viana
role: STUDY_DIRECTOR
References: