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

Hypertension Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04863755
• Other study ID #: 2017-0086
• Status: Completed
• Phase: N/A
• Start date: May 9, 2017
• Est. completion date: March 18, 2020

Study information

• Verified date: April 2021
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: March 18, 2020
• Est. primary completion date: March 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Hypertension

Intervention

Behavioral:
• DASH
Patients receive DASH diet orientation and recommended to maintain their usual physical activity
• DASHPED
Patients receive DASH diet orientation and recommended to increase their usual activity with the use of a pedometer

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Blood Pressure at 4 months	24 hours ambulatory blood pressure monitoring (ABPM)	Baseline and 4 months
Secondary	Change from Baseline Insulin Sensitivity at 4 months	HOMA index (using serum fasting insulin and glucose)	Baseline and 4 months
Secondary	Change from Baseline Glucose Profile at 4 months	Fasting glucose and A1C	Baseline and 4 months
Secondary	Change from Baseline Weight at 4 months anthropometric variables	weight in kilograms	Baseline and 4 months
Secondary	Change from Baseline BMI at 4 months	BMI in kg/m2	Baseline and 4 months
Secondary	Change from Baseline Skeletal muscle mass at 4 months	Skeletal muscle mass in Kilograms	Baseline and 4 months
Secondary	Change from Baseline Body fat mass at 4 months	Body fat mass in kilograms	Baseline and 4 months
Secondary	Change from Baseline Percent body Fat at 4 months	Percent body Fat (%)	Baseline and 4 months
Secondary	Change from Baseline Total cholesterol at 4 months	Total cholesterol in mg/dl	Baseline and 4 months
Secondary	Change from Baseline LDL cholesterol at 4 months	LDL cholesterol in mg/dl	Baseline and 4 months
Secondary	Change from Baseline Triglycerides at 4 months	Triglycerides in mg/dl	Baseline and 4 months
Secondary	Change from Baseline HDL cholesterol at 4 months	HDL cholesterol in mg/dl	Baseline and 4 months