- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04863755
Change of Lifestyle in Elderly Patients With Type 2 Diabetes and Systemic Arterial Hypertension
April 26, 2021 updated by: Hospital de Clinicas de Porto Alegre
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rio Grande Do Sul
-
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
- Hospital de Clinicas de Porto Alegre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 80 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: DASH diet only
Patients receive a DASH diet and orientation to maintain their physical activity
|
Patients receive DASH diet orientation and recommended to maintain their usual physical activity
|
Other: DASH diet with pedometer
Patients receive a DASH diet and orientation to increase their physical activity with a pedometer steps count
|
Patients receive DASH diet orientation and recommended to increase their usual activity with the use of a pedometer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Blood Pressure at 4 months
Time Frame: Baseline and 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
Time Frame: Baseline and 4 months
|
HOMA index (using serum fasting insulin and glucose)
|
Baseline and 4 months
|
Change from Baseline Glucose Profile at 4 months
Time Frame: Baseline and 4 months
|
Fasting glucose and A1C
|
Baseline and 4 months
|
Change from Baseline Weight at 4 months anthropometric variables
Time Frame: Baseline and 4 months
|
weight in kilograms
|
Baseline and 4 months
|
Change from Baseline BMI at 4 months
Time Frame: Baseline and 4 months
|
BMI in kg/m2
|
Baseline and 4 months
|
Change from Baseline Skeletal muscle mass at 4 months
Time Frame: Baseline and 4 months
|
Skeletal muscle mass in Kilograms
|
Baseline and 4 months
|
Change from Baseline Body fat mass at 4 months
Time Frame: Baseline and 4 months
|
Body fat mass in kilograms
|
Baseline and 4 months
|
Change from Baseline Percent body Fat at 4 months
Time Frame: Baseline and 4 months
|
Percent body Fat (%)
|
Baseline and 4 months
|
Change from Baseline Total cholesterol at 4 months
Time Frame: Baseline and 4 months
|
Total cholesterol in mg/dl
|
Baseline and 4 months
|
Change from Baseline LDL cholesterol at 4 months
Time Frame: Baseline and 4 months
|
LDL cholesterol in mg/dl
|
Baseline and 4 months
|
Change from Baseline Triglycerides at 4 months
Time Frame: Baseline and 4 months
|
Triglycerides in mg/dl
|
Baseline and 4 months
|
Change from Baseline HDL cholesterol at 4 months
Time Frame: Baseline and 4 months
|
HDL cholesterol in mg/dl
|
Baseline and 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Luciana Verçoza Viana, Hospital de Clinicas de Porto Alegre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 9, 2017
Primary Completion (Actual)
March 18, 2020
Study Completion (Actual)
March 18, 2020
Study Registration Dates
First Submitted
April 8, 2021
First Submitted That Met QC Criteria
April 26, 2021
First Posted (Actual)
April 28, 2021
Study Record Updates
Last Update Posted (Actual)
April 28, 2021
Last Update Submitted That Met QC Criteria
April 26, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-0086
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
after publication
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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