Change of Lifestyle in Elderly Patients With Type 2 Diabetes and Systemic Arterial Hypertension
- Conditions
- DiabetesHypertension
- Interventions
- Behavioral: DASHBehavioral: DASHPED
- Registration Number
- NCT04863755
- Lead Sponsor
- Hospital de Clinicas de Porto Alegre
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
- Age 60 years or more
- Diabetes Mellitus
- Hypertension with poor control
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description DASH diet only DASH Patients receive a DASH diet and orientation to maintain their physical activity DASH diet with pedometer DASHPED Patients receive a DASH diet and orientation to increase their physical activity with a pedometer steps count
- Primary Outcome Measures
Name Time Method Change from Baseline Blood Pressure at 4 months Baseline and 4 months 24 hours ambulatory blood pressure monitoring (ABPM)
- Secondary Outcome Measures
Name Time Method Change from Baseline Insulin Sensitivity at 4 months Baseline and 4 months HOMA index (using serum fasting insulin and glucose)
Change from Baseline Skeletal muscle mass at 4 months Baseline and 4 months Skeletal muscle mass in Kilograms
Change from Baseline Total cholesterol at 4 months Baseline and 4 months Total cholesterol in mg/dl
Change from Baseline Triglycerides at 4 months Baseline and 4 months Triglycerides in mg/dl
Change from Baseline Percent body Fat at 4 months Baseline and 4 months Percent body Fat (%)
Change from Baseline HDL cholesterol at 4 months Baseline and 4 months HDL cholesterol in mg/dl
Change from Baseline Body fat mass at 4 months Baseline and 4 months Body fat mass in kilograms
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 LDL cholesterol at 4 months Baseline and 4 months LDL cholesterol in mg/dl
Trial Locations
- Locations (1)
Hospital de Clínicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil