DiabetesNCT04863755
Change of Lifestyle in Elderly Patients With Type 2 Diabetes and Systemic Arterial Hypertension
A study testing DASH and DASHPED in people with Diabetes and Hypertension, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Diabetes, Hypertension
- What is being tested?
- DASH and DASHPED
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteBrazil
- Study dates
- 9 May 2017to 18 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 60 years or more
- Diabetes Mellitus
- Hypertension with poor control
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
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
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.
Read the 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.
- Conditions
- Diabetes, Hypertension
- Being tested
- DASH, DASHPED
- Keywords
- Diabetes, Hypertension, Elderly, DASH, Steps
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASHBehavioural
Patients receive DASH diet orientation and recommended to maintain their usual physical activity
DASHPEDBehavioural
Patients receive DASH diet orientation and recommended to increase their usual activity with the use of a pedometer
| Study group | Role | What they receive |
|---|---|---|
| DASH diet only | Other | Patients receive a DASH diet and orientation to maintain their physical activity Receives: Behavioral: DASH |
| DASH diet with pedometer | Other | Patients receive a DASH diet and orientation to increase their physical activity with a pedometer steps count Receives: Behavioral: DASHPED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Blood Pressure at 4 months
24 hours ambulatory blood pressure monitoring (ABPM)
Measured: Baseline and 4 months
Secondary outcomes (11)
Change from Baseline Insulin Sensitivity at 4 months
HOMA index (using serum fasting insulin and glucose)
Measured: Baseline and 4 months
Change from Baseline Glucose Profile at 4 months
Fasting glucose and A1C
Measured: Baseline and 4 months
Change from Baseline Weight at 4 months anthropometric variables
weight in kilograms
Measured: Baseline and 4 months
Change from Baseline BMI at 4 months
BMI in kg/m2
Measured: Baseline and 4 months
Change from Baseline Skeletal muscle mass at 4 months
Skeletal muscle mass in Kilograms
Measured: Baseline and 4 months
Change from Baseline Body fat mass at 4 months
Body fat mass in kilograms
Measured: Baseline and 4 months
Change from Baseline Percent body Fat at 4 months
Percent body Fat (%)
Measured: Baseline and 4 months
Change from Baseline Total cholesterol at 4 months
Total cholesterol in mg/dl
Measured: Baseline and 4 months
Change from Baseline LDL cholesterol at 4 months
LDL cholesterol in mg/dl
Measured: Baseline and 4 months
Change from Baseline Triglycerides at 4 months
Triglycerides in mg/dl
Measured: Baseline and 4 months
Change from Baseline HDL cholesterol at 4 months
HDL cholesterol in mg/dl
Measured: Baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start9 May 2017
- Primary completion18 Mar 2020
- Study completion18 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Health Science of Porto Alegre
- Responsible party
- Sponsor
- Investigators
- Luciana Verçoza Viana, Study director, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863755
- Sponsor's protocol ID
- 2017-0086
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: after publication
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04863755
- Acronym / sponsor ID
- 2017-0086
- Conditions
- Diabetes, Hypertension
- Keywords
- Diabetes, Hypertension, Elderly, DASH, Steps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Health Science of Porto Alegre
- Study start
- 9 May 2017 (actual)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 18 Mar 2020 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DASH diet only | Other | Behavioral: DASHPatients receive a DASH diet and orientation to maintain their physical activity |
| DASH diet with pedometer | Other | Behavioral: DASHPEDPatients receive a DASH diet and orientation to increase their physical activity with a pedometer steps count |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age 60 years or more
- Diabetes Mellitus
- Hypertension with poor control
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DASHPatients receive DASH diet orientation and recommended to maintain their usual physical activity | Behavioural | DASH diet only |
| DASHPEDPatients receive DASH diet orientation and recommended to increase their usual activity with the use of a pedometer | Behavioural | DASH diet with pedometer |
Primary outcome
Change from Baseline Blood Pressure at 4 months
Time frame: Baseline and 4 months
24 hours ambulatory blood pressure monitoring (ABPM)
11 secondary outcomes
Change from Baseline Insulin Sensitivity at 4 months
Time frame: Baseline and 4 months
Change from Baseline Glucose Profile at 4 months
Time frame: Baseline and 4 months
Change from Baseline Weight at 4 months anthropometric variables
Time frame: Baseline and 4 months
Change from Baseline BMI at 4 months
Time frame: Baseline and 4 months
Change from Baseline Skeletal muscle mass at 4 months
Time frame: Baseline and 4 months
Change from Baseline Body fat mass at 4 months
Time frame: Baseline and 4 months
Change from Baseline Percent body Fat at 4 months
Time frame: Baseline and 4 months
Change from Baseline Total cholesterol at 4 months
Time frame: Baseline and 4 months
Change from Baseline LDL cholesterol at 4 months
Time frame: Baseline and 4 months
Change from Baseline Triglycerides at 4 months
Time frame: Baseline and 4 months
Change from Baseline HDL cholesterol at 4 months
Time frame: Baseline and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No. after publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciana Verçoza Viana study director
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DASH and DASHPED in people with Diabetes and Hypertension, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Blood Pressure at 4 months (time frame: Baseline and 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.