Diabetes Prevention in Prediabetic Patients

Prediabetes Clinical Trial

— DPEP  

Official title:

Diabetes Prevention in Patients Aged 25-55 From Ethiopian Origin With Prediabetes: Evaluation of Feasibility and Efficacy of Intensive or Less Intensive Lifestyle Intervention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01659697
• Other study ID #: 057/2012
• Status: Not yet recruiting
• Phase: N/A
• First received: August 5, 2012
• Last updated: August 5, 2012
• Start date: August 2012
• Est. completion date: July 2015

Study information

• Verified date: August 2012
• Source: Meir Medical Center
• Contact: Joelle S Singer, M.D.
• Phone: +972506263652
• Email: jsinger[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Observational

Clinical Trial Summary

This study will evaluate the feasibility and efficacy of two interventions of lifestyle ( intensive and less intensive) to prevent diabetes in patients from Ethiopian origin, aged 25 to 55 years old with prediabetes living in Israel and insured by Clalit Health Services in the Central district, using resources existing in this Health Care system (HMO).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 55 Years

Eligibility

Inclusion Criteria:

• prediabetes

• age 25-55

• ethiopian origin

Exclusion Criteria:

• diabetes

• age under 25 or above 55

• non ethiopian origin

Study Design

Observational Model: Family-Based, Time Perspective: Prospective

Related Conditions & MeSH terms

• Community Health Services
• Ethnic Group
• Glucose Intolerance
• Prediabetes
• Prediabetic State
• Young Adults

Intervention

Behavioral:
• intensive lifestyle counseling
Intensive lifestyle counseling will include a bi annual visit of the primary physician and nurse, a group intervention about use of medical resources, healthy lifestyle a one to one intervention with a dietician about diet and a one to one intervention with a physiotherapist about exercise

Locations

Country	Name	City	State
Israel	Central district Clalit Health Services	Rishon Le Zion

Sponsors (2)

Lead Sponsor	Collaborator
Meir Medical Center	Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurence of diabetes	Patients included in the study will have a one year lifestyle intervention ( two arms: intensive, less intensive) and will be followed for two years for the occurence of diabetes	two years period	No
Secondary	change in Body Mass index and Physical activity		two years	No