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

February 19, 2013 updated by: Osamah Hussein, Ziv Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

670

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Safed, Israel, 13110
        • Recruiting
        • Ziv Medical Center
        • Contact:
        • Principal Investigator:
          • Osamah Hussein, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Circassians in Israel

Description

Inclusion Criteria:

Previous participation in similar study which was occured 10 years ago

Exclusion Criteria:

none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rehania village (Kfar Rehania)
Circassian community
Other: NONE intervention
NONE intervention
Kama village (Kfar Kama )
Circassian community
Other: NONE intervention
NONE intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
New incidences of Type II Diabetes Mellitus in Circassians minority in Israel
Time Frame: 14 years
14 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziv Hospital

Collaborators

Clalit Health Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

March 6, 2011

First Submitted That Met QC Criteria

March 8, 2011

First Posted (Estimate)

March 9, 2011

Study Record Updates

Last Update Posted (Estimate)

February 20, 2013

Last Update Submitted That Met QC Criteria

February 19, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0067-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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