The Effect of DASH Diet on the Cardiometabolic Risks and Hepatic Function Among Type 2 Diabetic Patients
Sponsor
Isfahan University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT01049321
Collaborator
Shahid Motahari Hospital of Fooladshahr, Isfahan Steel Company, Isfahan (Other)
36
1
2
12
3
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
36 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date
:
Dec 1, 2008
Actual Primary Completion Date
:
Jun 1, 2009
Actual Study Completion Date
:
Dec 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DASH diet DASH: Dietary approaches to stop hypertension eating plan |
Dietary Supplement: DASH diet
Other Names:
|
| Placebo Comparator: Diabetic diet Diabetic diet: a usual diabetic diet |
Dietary Supplement: a usual diabetic diet
|
Outcome Measures
Primary Outcome Measures
- Cardio-metabolic risks [6 months]
Secondary Outcome Measures
- Hepatic function [6 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
44 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Having type 2 diabetes
Exclusion Criteria:
- Having other chronic disease, hepatic or kidney disorders, cancer, hormone therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shahid motahari hospital, Esfahan Esteel company, Iran | Isfahan | Iran, Islamic Republic of |
Sponsors and Collaborators
- Isfahan University of Medical Sciences
- Shahid Motahari Hospital of Fooladshahr, Isfahan Steel Company, Isfahan
Investigators
- Principal Investigator: Leila Azadbakht, PhD, Isfahan University of Medical Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01049321
Other Study ID Numbers:
- DASH and cardiovascular risks
First Posted:
Jan 14, 2010
Last Update Posted:
Jan 14, 2010
Last Verified:
Mar 1, 2008
Keywords provided by ,
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