NCT01049321

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed
Last Updated

January 14, 2010

Status Verified

March 1, 2008

Enrollment Period

6 months

First QC Date

January 13, 2010

Last Update Submit

January 13, 2010

Conditions

Type 2 Diabetic Patients

Keywords

Dietary Approach to Stop HypertensionweightcoagulationDASH eating pattern.

Outcome Measures

Primary Outcomes (1)

  • Cardio-metabolic risks

    6 months

Secondary Outcomes (1)

  • Hepatic function

    6 months

Study Arms (2)

DASH diet

EXPERIMENTAL

DASH: Dietary approaches to stop hypertension eating plan

Dietary Supplement: DASH diet

Diabetic diet

PLACEBO COMPARATOR

Diabetic diet: a usual diabetic diet

Dietary Supplement: a usual diabetic diet

Interventions

DASH dietDIETARY_SUPPLEMENT
Also known as: Dietary aproaches to stop hypertension
DASH diet
a usual diabetic dietDIETARY_SUPPLEMENT
Diabetic diet

Eligibility Criteria

Age44 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having type 2 diabetes

You may not qualify if:

  • Having other chronic disease, hepatic or kidney disorders, cancer, hormone therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid motahari hospital, Esfahan Esteel company, Iran

Isfahan, Iran

Location

Related Publications (1)

  • 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.

    PMID: 21525259DERIVED

MeSH Terms

Conditions

Body WeightThrombosis

Interventions

Dietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Leila Azadbakht, PhD

    Isfahan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 14, 2010

Study Start

December 1, 2008

Primary Completion

June 1, 2009

Study Completion

December 1, 2009

Last Updated

January 14, 2010

Record last verified: 2008-03

Locations

IR(1)