Type 2 Diabetic PatientsPhase 4NCT01049321
The Effect of DASH Diet on the Cardiometabolic Risks and Hepatic Function Among Type 2 Diabetic Patients
A Phase 4 study testing DASH diet and a usual diabetic diet in people with Type 2 Diabetic Patients, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The investigators are not aware of any study regarding the effect of DASH eating pattern on different cardiovascular risks among type 2 diabetic patients. The investigators assumed that DASH eating pattern could reduce the cardio-metabolic risks and improve the hepatic function among type 2 diabetes. Read more about this study
- Who is it for?
- Ages 44 to 70 years
- Conditions the study is for
- Type 2 Diabetic Patients
- What is being tested?
- DASH diet and a usual diabetic diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteIran
- Study dates
- Dec 2008to Dec 2009
- Phase
- Phase 4
- 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 44 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having type 2 diabetes
Who cannot join
- Having other chronic disease, hepatic or kidney disorders, cancer, hormone therapy
Trial locations and contacts
1 site in 1 country.
About this study
The investigators are not aware of any study regarding the effect of DASH eating pattern on different cardiovascular risks among type 2 diabetic patients. The investigators assumed that DASH eating pattern could reduce the cardio-metabolic risks and improve the hepatic function among type 2 diabetes.
- Conditions
- Type 2 Diabetic Patients
- Being tested
- DASH diet, a usual diabetic diet
- Keywords
- Dietary Approach to Stop Hypertension, weight, coagulation, DASH eating pattern.
- Medical subject headings
- Body Weight, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH dietDietary supplement
Also called Dietary aproaches to stop hypertension
a usual diabetic dietDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| DASH diet | Experimental | DASH: Dietary approaches to stop hypertension eating plan Receives: Dietary Supplement: DASH diet |
| Diabetic diet | Placebo comparator | Diabetic diet: a usual diabetic diet Receives: Dietary Supplement: a usual diabetic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardio-metabolic risks
Measured: 6 months
Secondary outcomes (1)
Hepatic function
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startDec 2008
- Primary completionJun 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetic PatientsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Motahari Hospital of Fooladshahr, Isfahan Steel Company, Isfahan
- Investigators
- Leila Azadbakht, PhD, Principal investigator, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049321
- Sponsor's protocol ID
- DASH and cardiovascular risks
- Status last verified
- Mar 2008
- First submitted
- 13 Jan 2010
- Last updated
- 14 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Azadbakht L, Surkan PJ, Esmaillzadeh A, Willett WC. The Dietary Approaches to Stop Hypertension eating plan affects C-reactive protein, coagulation abnormalities, and hepatic function tests among type 2 diabetic patients. J Nutr. 2011 Jun;141(6):1083-8. doi: 10.3945/jn.110.136739. Epub 2011 Apr 27.
PubMed 21525259
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of DASH Diet on the Cardiometabolic Risks and Hepatic Function Among Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT01049321
- Acronym / sponsor ID
- DASH and cardiovascular risks
- Conditions
- Type 2 Diabetic Patients
- Keywords
- Dietary Approach to Stop Hypertension, weight, coagulation, DASH eating pattern.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Collaborators
- Shahid Motahari Hospital of Fooladshahr, Isfahan Steel Company, Isfahan
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 14 Jan 2010 (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.
The investigators are not aware of any study regarding the effect of DASH eating pattern on different cardiovascular risks among type 2 diabetic patients. The investigators assumed that DASH eating pattern could reduce the cardio-metabolic risks and improve the hepatic function among type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DASH diet | Experimental | Dietary Supplement: DASH dietDASH: Dietary approaches to stop hypertension eating plan |
| Diabetic diet | Placebo comparator | Dietary Supplement: a usual diabetic dietDiabetic diet: a usual diabetic diet |
Who may qualify
- Ages
- 44 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Having type 2 diabetes
Key exclusion criteria (1 listed)
- Having other chronic disease, hepatic or kidney disorders, cancer, hormone therapy
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 dietAlso: Dietary aproaches to stop hypertension | Dietary supplement | DASH diet |
| a usual diabetic diet | Dietary supplement | Diabetic diet |
Primary outcome
Cardio-metabolic risks
Time frame: 6 months
1 secondary outcome
Hepatic function
Time frame: 6 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 14 Jan 2010.
- Derived from this study: PubMed 21525259Azadbakht L, Surkan PJ, Esmaillzadeh A, Willett WC. The Dietary Approaches to Stop Hypertension eating plan affects C-reactive protein, coagulation abnormalities, and hepatic function tests among type 2 diabetic patients. J Nutr. 2011 Jun;141(6):1083-8. doi: 10.3945/jn.110.136739. Epub 2011 Apr 27.
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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.
Leila Azadbakht, PhD principal investigator
Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DASH diet and a usual diabetic diet in people with Type 2 Diabetic Patients, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 1 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 14 Jan 2010. 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 Iran. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cardio-metabolic risks (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01049321, which also lists 1 linked publication.
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 14 Jan 2010; AzTrials last refreshed its copy on 6 Nov 2026.