Predictors of Future Type 2 Diabetes Mellitus in Circassians Minority in Israel

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Ziv Hospital
Sponsor:
Collaborator:
Clalit Health Services
Information provided by (Responsible Party):
Osamah Hussein, Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01311401
First received: March 6, 2011
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

The aim

The aim of the present study is:

  1. The metabolic risk factors that can predict diabetes after 10 years in a Circassians population-based sample of people who were aged 35 years or older and living in Israel.
  2. To define the incidence of type 2 diabetes mellitus in Circassians minority in Israel.

The hypothesis of the study:

High fasting glucose has the most powerful predictive value for type 2 diabetes mellitus in the future.

The claimed importance of the study:

Finding a powerful risk factor for future diabetes mellitus can contribute to intensifying the preventive measures in a small part of the population, by that to reduce the incidence of new diabetes without increasing the health cost.


Condition Intervention
Diabetes Mellitus Type II
Other: NONE intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictors of Future Type 2 Diabetes Mellitus in Circassians Minority in Israel

Resource links provided by NLM:


Further study details as provided by Ziv Hospital:

Primary Outcome Measures:
  • New incidences of Type II Diabetes Mellitus in Circassians minority in Israel [ Time Frame: 14 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 670
Study Start Date: October 2009
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Rehania village (Kfar Rehania)
Circassian community
Other: NONE intervention
NONE intervention
Kama village (Kfar Kama )
Circassian community
Other: NONE intervention
NONE intervention

Detailed Description:

Research design and methods The present study is a 10 year, nested prospective cohort, population-based survey of the metabolic syndrome risk factors including type 2 diabetes mellitus. The original cross-sectional survey was conducted in two small Circassian villages in north Israel with 4000 inhabitants. The baseline evaluation was performed between 1996 and - 1997. Among the 739 randomly selected men (n=289) and women (n=450 of the 4000 individuals who were aged 35 years or older. Mean age of men was 53.2±11.8 years and of women was 52± years. Mean BMI for men and women was 27.5± and 29.4± Kg/m2, respectively. Plasma glucose level for men and women was mg/dL(22).

The investigators will recruit the same cohort in the proposed study and individuals who were free of diabetes at base line will be included. The number of deceased changed their residence and those who will decline to participate in the follow-up study will be reported.

The protocol was approved by the Ethics Committee of the Ziv hospital and all participants will give an informed consent.

Clinical data. Body mass index (BMI), fasting blood glucose, blood total cholesterol, triglycerides, low density cholesterol (LDL), high density cholesterol (HDL) and blood pressure measurements were done 10 years ago. In the present study, after 8 hours of caloric fast, blood glucose levels will be tested and patients will be asked about known recent diabetes mellitus in the last 10 years or treatment by dietary, hypoglycemic drugs or insulin.

Laboratory data. In the morning, after an overnight caloric fast, venous blood will be sampled for the measurement of plasma concentrations of glucose. The blood levels of glucose will be done by Olympus 640 at ZIV hospital. Diagnosis of diabetes. At baseline and at the 10-year follow-up, the presence of diabetes will be established according to World Health Organization (WHO) criteria (84), i.e., when fasting glucose will be ≥126 mg/dl or when the participants will have a clinical diagnosis of the disease and treatment was ongoing (diet, drugs).

The presence of the disease will be confirmed by reviewing the medical records of their general practitioners. No case of diabetes will be accepted without a validated confirmation.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Circassians in Israel

Criteria

Inclusion Criteria:

Previous participation in similar study which was occured 10 years ago

Exclusion Criteria:

none

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311401

Contacts
Contact: Osamah Hussein, MD +972 505324913 osama.h@ziv.health.gov.il

Locations
Israel
Ziv Medical Center Recruiting
Safed, Israel, 13110
Contact: Osamah Hussein, MD       osama.h@ziv.health.gov.il   
Principal Investigator: Osamah Hussein, MD         
Sponsors and Collaborators
Ziv Hospital
Clalit Health Services
  More Information

No publications provided

Responsible Party: Osamah Hussein, Dr. Osamah Hussein, Ziv Hospital
ClinicalTrials.gov Identifier: NCT01311401     History of Changes
Other Study ID Numbers: 0067-08
Study First Received: March 6, 2011
Last Updated: February 19, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Ziv Hospital:
2 diabetes mellitus,Circassians, High fasting glucose

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014