Blood PressureNCT01461330
Lifestyle Changes in Patients With Type 2 Diabetes Mellitus and Hypertension
A study testing DASH diet plus exercise and ADA diet in people with Blood Pressure, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Data obtained in hypertensive patients without diabetes suggest that increased association of non-pharmacological treatment in patients with diabetes and hypertension may be associated with an improvement in blood pressure control. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Blood Pressure
- What is being tested?
- DASH diet plus exercise and ADA diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2011to Nov 2013
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes
- Blood pressure ≥140/90 mm Hg
- ABMP ≥ 135/85 mm Hg
Who cannot join
- digestive disease with malabsorption
- diabetic neuropathy with gastroparesis
- BMI ≥ 40 kg/m²
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
About this study
Official title: Lifestyle Changes in Patients With Type 2 DM and Hypertension: DASH Diet and Exercise Effects
Data obtained in hypertensive patients without diabetes suggest that increased association of non-pharmacological treatment in patients with diabetes and hypertension may be associated with an improvement in blood pressure control. Despite the beneficial results found, is not yet known the magnitude of the effect of a DASH diet associated with the stimulus of physical activity on BP in patients with type 2 diabetes. The beneficial effects on blood pressure of an additional non-pharmacological intervention to drug therapy may have an even greater impact in patients with treatment-resistant hypertension The aim of this study is to evaluate the effect of changes in lifestyle on blood pressure in patients with type 2 diabetes and hypertension resistant to treatment.
Read the detailed description
The aim of this study is to evaluate the effect of changes in lifestyle on blood pressure in patients with type 2 diabetes and hypertension. Secondary objectives are: Assess whether the prescription of a DASH-type diet and encouragement for physical activity through use of pedometers, can improve blood pressure control in patients with type 2 diabetes and hypertension resistant to treatment.
Forty type 2 diabetic with resistant hypertension outpatients were included in a randomized clinical trial: treatment 1- DASH diet + encouragement for physical activity through use of pedometer; treatment 2- ADA diet + usual exercises. The duration of each treatment are four weeks. The patients included should have performed Ambulatory Blood Pressure Monitoring (ABPM) to exclude white-coat effect, ie when there are abnormal in the measurement of office blood pressure (equal to or above 140/90 mm Hg) and normal blood pressure by ABPM during the awake period (equal to or below 135/85 mm Hg). Twenty-four hour records with concurrent 24h urinary collections (protein intake estimative), clinical and laboratory evaluation were performed at baseline and after 4 weeks. Serum fatty acids were measured in total lipids by gas chromatography.
- Conditions
- Blood Pressure
- Being tested
- DASH diet plus exercise, ADA diet
- Keywords
- diabetes, exercise, DASH diet, ABPM
- Medical subject headings
- Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH diet plus exerciseOther
Also called LYFESTYLE INTERVENTION
DASH diet adapted to the usual diet of Brazilian type 2 diabetic patients = prescription of a normocaloric diet including fruits, vegetables, grain products, low fat dairy foods, legumes, without sugar, and with limited fat
Exercises: the recommended physical activity will consist of using a pedometer during the experimental period.
ADA dietOther
Also called Active comparator: ADA DIET
Adoption of ADA diet.
| Study group | Role | What they receive |
|---|---|---|
| DASH diet | Experimental | DASH DIET + EXERCISE Receives: Other: DASH diet plus exercise |
| ADA DIET | Active comparator | DIET ACCORDING AMERICAN DIABETES ASSOCIATION DIETARY RECOMMENDATIONS FOR DIABETES Receives: Other: ADA diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Blood Pressure at 4 weeks
Ambulatory Blood Pressure Monitoring (ABPM) at baseline and after 4 weeks
Measured: 4 weeks
Secondary outcomes (1)
Change from Baseline in glucose control at 4 weeks
A1 C test at baseline and after 4 weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startFeb 2011
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intervention: DASH diet plus exercise DASH diet adapted to the usual diet of Brazilian type 2 diabetic patients = prescription of a normocaloric diet including fruits, vegetables, grain products, low fat dairy foods, legumes, without sugar, and with limited fat Exercises: the recommended physical activity will consist of using a pedometer during the experimental period. active comparator = ADA diet = Adoption of ADA diet.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirela Jobim de Azevedo, Hospital de Clinicas de Porto Alegre
- Investigators
- Tatiana P de Paula, RD, Study chair, Hospital de Clinicas de Porto AlegreLuciana Verzoça, MD, Study chair, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461330
- Sponsor's protocol ID
- HCPA 10-0411
- Status last verified
- Jan 2017
- First submitted
- 3 Aug 2011
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Changes in Patients With Type 2 DM and Hypertension: DASH Diet and Exercise Effects
- ClinicalTrials.gov ID
- NCT01461330
- Acronym / sponsor ID
- HCPA 10-0411
- Conditions
- Blood Pressure
- Keywords
- diabetes, exercise, DASH diet, ABPM
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Feb 2011 (actual)
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 28 Oct 2011 (estimated)
- 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.
Data obtained in hypertensive patients without diabetes suggest that increased association of non-pharmacological treatment in patients with diabetes and hypertension may be associated with an improvement in blood pressure control. Despite the beneficial results found, is not yet known the magnitude of the effect of a DASH diet associated with the stimulus of physical activity on BP in patients with type 2 diabetes. The beneficial effects on blood pressure of an additional non-pharmacological intervention to drug therapy may have an even greater impact in patients with treatment-resistant hypertension The aim of this study is to evaluate the effect of changes in lifestyle on blood pressure in patients with type 2 diabetes and hypertension resistant to treatment.
Detailed description
The aim of this study is to evaluate the effect of changes in lifestyle on blood pressure in patients with type 2 diabetes and hypertension. Secondary objectives are: Assess whether the prescription of a DASH-type diet and encouragement for physical activity through use of pedometers, can improve blood pressure control in patients with type 2 diabetes and hypertension resistant to treatment.
Forty type 2 diabetic with resistant hypertension outpatients were included in a randomized clinical trial: treatment 1- DASH diet + encouragement for physical activity through use of pedometer; treatment 2- ADA diet + usual exercises. The duration of each treatment are four weeks. The patients included should have performed Ambulatory Blood Pressure Monitoring (ABPM) to exclude white-coat effect, ie when there are abnormal in the measurement of office blood pressure (equal to or above 140/90 mm Hg) and normal blood pressure by ABPM during the awake period (equal to or below 135/85 mm Hg). Twenty-four hour records with concurrent 24h urinary collections (protein intake estimative), clinical and laboratory evaluation were performed at baseline and after 4 weeks. Serum fatty acids were measured in total lipids by gas chromatography.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- intervention: DASH diet plus exercise DASH diet adapted to the usual diet of Brazilian type 2 diabetic patients = prescription of a normocaloric diet including fruits, vegetables, grain products, low fat dairy foods, legumes, without sugar, and with limited fat Exercises: the recommended physical activity will consist of using a pedometer during the experimental period. active comparator = ADA diet = Adoption of ADA diet.
| Arm | Type | Receives |
|---|---|---|
| DASH diet | Experimental | Other: DASH diet plus exerciseDASH DIET + EXERCISE |
| ADA DIET | Active comparator | Other: ADA dietDIET ACCORDING AMERICAN DIABETES ASSOCIATION DIETARY RECOMMENDATIONS FOR DIABETES |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- type 2 diabetes
- Blood pressure ≥140/90 mm Hg
- ABMP ≥ 135/85 mm Hg
Key exclusion criteria (3 listed)
- digestive disease with malabsorption
- diabetic neuropathy with gastroparesis
- BMI ≥ 40 kg/m²
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 |
|---|---|---|
| DASH diet plus exerciseAlso: LYFESTYLE INTERVENTIONDASH diet adapted to the usual diet of Brazilian type 2 diabetic patients = prescription of a normocaloric diet including fruits, vegetables, grain products, low fat dairy foods, legumes, without sugar, and with limited fat Exercises: the recommended physical activity will consist of using a pedometer during the experimental period. | Other | DASH diet |
| ADA dietAlso: Active comparator: ADA DIETAdoption of ADA diet. | Other | ADA DIET |
Primary outcome
Change from Baseline in Blood Pressure at 4 weeks
Time frame: 4 weeks
Ambulatory Blood Pressure Monitoring (ABPM) at baseline and after 4 weeks
1 secondary outcome
Change from Baseline in glucose control at 4 weeks
Time frame: 4 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
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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.
Tatiana P de Paula, RD study chair
Hospital de Clinicas de Porto Alegre
Luciana Verzoça, MD study chair
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 diet plus exercise and ADA diet in people with Blood Pressure, 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 3 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: stopped early, as of the sponsor's last update on 26 Jan 2017. 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 was stopped early. Results are not available in the source record.
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 in Blood Pressure at 4 weeks (time frame: 4 weeks). 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 26 Jan 2017.