Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
NCT Number: NCT04863755
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.
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Notify Me65 year–80 year
All sexes
Interventional
Not applicable
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients receive DASH diet orientation and recommended to maintain their usual physical activity
Patients receive DASH diet orientation and recommended to increase their usual activity with the use of a pedometer
Time frame: Baseline and 4 months
24 hours ambulatory blood pressure monitoring (ABPM)
Time frame: Baseline and 4 months
HOMA index (using serum fasting insulin and glucose)
Time frame: Baseline and 4 months
Fasting glucose and A1C
Time frame: Baseline and 4 months
weight in kilograms
Time frame: Baseline and 4 months
BMI in kg/m2
Time frame: Baseline and 4 months
Skeletal muscle mass in Kilograms
Time frame: Baseline and 4 months
Body fat mass in kilograms
Time frame: Baseline and 4 months
Percent body Fat (%)
Time frame: Baseline and 4 months
Total cholesterol in mg/dl
Time frame: Baseline and 4 months
LDL cholesterol in mg/dl
Time frame: Baseline and 4 months
Triglycerides in mg/dl
Time frame: Baseline and 4 months
HDL cholesterol in mg/dl
Hospital de Clinicas de Porto Alegre
Other
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
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