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Completed

NCT Number: NCT04863755

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

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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Key information

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DASH

Behavioral

Patients receive DASH diet orientation and recommended to maintain their usual physical activity

DASHPED

Behavioral

Patients receive DASH diet orientation and recommended to increase their usual activity with the use of a pedometer

Primary outcomes

  1. Change from Baseline Blood Pressure at 4 months

    Time frame: Baseline and 4 months

    24 hours ambulatory blood pressure monitoring (ABPM)

Secondary outcomes

  1. Change from Baseline Insulin Sensitivity at 4 months

    Time frame: Baseline and 4 months

    HOMA index (using serum fasting insulin and glucose)

  2. Change from Baseline Glucose Profile at 4 months

    Time frame: Baseline and 4 months

    Fasting glucose and A1C

  3. Change from Baseline Weight at 4 months anthropometric variables

    Time frame: Baseline and 4 months

    weight in kilograms

  4. Change from Baseline BMI at 4 months

    Time frame: Baseline and 4 months

    BMI in kg/m2

  5. Change from Baseline Skeletal muscle mass at 4 months

    Time frame: Baseline and 4 months

    Skeletal muscle mass in Kilograms

  6. Change from Baseline Body fat mass at 4 months

    Time frame: Baseline and 4 months

    Body fat mass in kilograms

  7. Change from Baseline Percent body Fat at 4 months

    Time frame: Baseline and 4 months

    Percent body Fat (%)

  8. Change from Baseline Total cholesterol at 4 months

    Time frame: Baseline and 4 months

    Total cholesterol in mg/dl

  9. Change from Baseline LDL cholesterol at 4 months

    Time frame: Baseline and 4 months

    LDL cholesterol in mg/dl

  10. Change from Baseline Triglycerides at 4 months

    Time frame: Baseline and 4 months

    Triglycerides in mg/dl

  11. Change from Baseline HDL cholesterol at 4 months

    Time frame: Baseline and 4 months

    HDL cholesterol in mg/dl

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Federal University of Health Science of Porto Alegre

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 28, 2021
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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