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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hypertension, Diabetes

Intervention / Treatment
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* Behavioral: DASH
* Behavioral: DASHPED


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DASH diet only<br>Patients receive a DASH diet and orientation to maintain their physical activity | Behavioral: DASH<br>* Patients receive DASH diet orientation and recommended to maintain their usual physical activity<br>|
| Other: DASH diet with pedometer<br>Patients receive a DASH diet and orientation to increase their physical activity with a pedometer steps count | Behavioral: DASHPED<br>* Patients receive DASH diet orientation and recommended to increase their usual activity with the use of a pedometer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Blood Pressure at 4 months | 24 hours ambulatory blood pressure monitoring (ABPM) | Baseline and 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Insulin Sensitivity at 4 months | HOMA index (using serum fasting insulin and glucose) | Baseline and 4 months | 
| Change from Baseline Glucose Profile at 4 months | Fasting glucose and A1C | Baseline and 4 months | 
| Change from Baseline Weight at 4 months anthropometric variables | weight in kilograms | Baseline and 4 months | 
| Change from Baseline BMI at 4 months | BMI in kg/m2 | Baseline and 4 months | 
| Change from Baseline Skeletal muscle mass at 4 months | Skeletal muscle mass in Kilograms | Baseline and 4 months | 
| Change from Baseline Body fat mass at 4 months | Body fat mass in kilograms | Baseline and 4 months | 
| Change from Baseline Percent body Fat at 4 months | Percent body Fat (%) | Baseline and 4 months | 
| Change from Baseline Total cholesterol at 4 months | Total cholesterol in mg/dl | Baseline and 4 months | 
| Change from Baseline LDL cholesterol at 4 months | LDL cholesterol in mg/dl | Baseline and 4 months | 
| Change from Baseline Triglycerides at 4 months | Triglycerides in mg/dl | Baseline and 4 months | 
| Change from Baseline HDL cholesterol at 4 months | HDL cholesterol in mg/dl | Baseline and 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, DASH, Steps, Diabetes, Hypertension