Diabetes, Hypertension
Conditions
Keywords
Diabetes, Hypertension, Elderly, DASH, Steps
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.
Interventions
BEHAVIORALDASH
Patients receive DASH diet orientation and recommended to maintain their usual physical activity
BEHAVIORALDASHPED
Patients receive DASH diet orientation and recommended to increase their usual activity with the use of a pedometer
Sponsors
Federal University of Health Science of Porto Alegre
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Blood Pressure at 4 months | Baseline and 4 months | 24 hours ambulatory blood pressure monitoring (ABPM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Glucose Profile at 4 months | Baseline and 4 months | Fasting glucose and A1C |
| Change from Baseline Weight at 4 months anthropometric variables | Baseline and 4 months | weight in kilograms |
| Change from Baseline BMI at 4 months | Baseline and 4 months | BMI in kg/m2 |
| Change from Baseline Skeletal muscle mass at 4 months | Baseline and 4 months | Skeletal muscle mass in Kilograms |
| Change from Baseline Body fat mass at 4 months | Baseline and 4 months | Body fat mass in kilograms |
| Change from Baseline Insulin Sensitivity at 4 months | Baseline and 4 months | HOMA index (using serum fasting insulin and glucose) |
| Change from Baseline Total cholesterol at 4 months | Baseline and 4 months | Total cholesterol in mg/dl |
| Change from Baseline LDL cholesterol at 4 months | Baseline and 4 months | LDL cholesterol in mg/dl |
| Change from Baseline Triglycerides at 4 months | Baseline and 4 months | Triglycerides in mg/dl |
| Change from Baseline HDL cholesterol at 4 months | Baseline and 4 months | HDL cholesterol in mg/dl |
| Change from Baseline Percent body Fat at 4 months | Baseline and 4 months | Percent body Fat (%) |
Countries
Brazil
Outcome results
None listed