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Diabetes Prevention in Prediabetic Patients (DPEP)

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ClinicalTrials.gov Identifier: NCT01659697
Recruitment Status : Unknown
Verified August 2012 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 8, 2012
Last Update Posted : August 8, 2012
Sponsor:
Collaborator:
Clalit Health Services
Information provided by (Responsible Party):
Meir Medical Center

Brief 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).

Condition or disease Intervention/treatment
Ethnic Group Young Adults Prediabetes Community Health Services Behavioral: intensive lifestyle counseling

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Family-Based
Time Perspective: Prospective
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
Study Start Date : August 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes
U.S. FDA Resources

Group/Cohort Intervention/treatment
Intensive Lifestyle counseling 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
usual lifestyle counseling 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



Primary Outcome Measures :
  1. occurence of diabetes [ Time Frame: two years period ]
    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


Secondary Outcome Measures :
  1. change in Body Mass index and Physical activity [ Time Frame: two years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients aged 25-55 from Ethiopian origin leaving in Israel with pre diabetes
Criteria

Inclusion Criteria:

  • prediabetes
  • age 25-55
  • ethiopian origin

Exclusion Criteria:

  • diabetes
  • age under 25 or above 55
  • non ethiopian origin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659697


Contacts
Contact: Joelle S Singer, M.D. +972506263652 jsinger@clalit.org.il
Contact: Dalia Blumenthal, M.D. +972523583372 blumed@bezeqint.net

Locations
Israel
Central district Clalit Health Services
Rishon Le Zion, Israel
Sponsors and Collaborators
Meir Medical Center
Clalit Health Services
Investigators
Principal Investigator: Joelle A Singer, M.D. Meir Medical Center
Study Director: Dalia Blumenthal, M.D. Meir Medical Center

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01659697     History of Changes
Other Study ID Numbers: 057/2012
First Posted: August 8, 2012    Key Record Dates
Last Update Posted: August 8, 2012
Last Verified: August 2012

Keywords provided by Meir Medical Center:
lifestyle
diabetes prevention
BMI
physical activity

Additional relevant MeSH terms:
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia