Diabetes Mellitus Type IINCT01311401
Predictors of Future Type 2 Diabetes Mellitus in Circassians Minority in Israel
An observational study of Diabetes Mellitus Type II, run by Ziv Hospital at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Type II
- What is being tested?
- NONE intervention
- How many people
- 670 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2009to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Circassians in Israel
Who may be able to join
- Previous participation in similar study which was occured 10 years ago
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Ziv Medical Center
Safed, 13110
Osamah Hussein, MD, osama.h@ziv.health.gov.il
Osamah Hussein, MD
About this study
The aim
The aim of the present study is:
- 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.
- 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.
Read the 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.
- Conditions
- Diabetes Mellitus Type II
- Being tested
- NONE intervention
- Keywords
- 2 diabetes mellitus,Circassians, High fasting glucose
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NONE interventionOther
NONE intervention
| Study group | Role | What they receive |
|---|---|---|
| Rehania village (Kfar Rehania) | Circassian community Receives: Other: NONE intervention | |
| Kama village (Kfar Kama ) | Circassian community Receives: Other: NONE intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
New incidences of Type II Diabetes Mellitus in Circassians minority in Israel
Measured: 14 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startOct 2009
- Primary completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 670 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Collaborators
- Clalit Health Services
- Responsible party
- Principal investigator, Osamah Hussein, Ziv Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311401
- Sponsor's protocol ID
- 0067-08
- Status last verified
- Feb 2013
- First submitted
- 6 Mar 2011
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Future Type 2 Diabetes Mellitus in Circassians Minority in Israel
- ClinicalTrials.gov ID
- NCT01311401
- Acronym / sponsor ID
- 0067-08
- Conditions
- Diabetes Mellitus Type II
- Keywords
- 2 diabetes mellitus,Circassians, High fasting glucose
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 670 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Collaborators
- Clalit Health Services
- Study start
- Oct 2009
- Primary completion
- Jul 2014 (estimated)
- First posted
- 9 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim
The aim of the present study is:
- 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.
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehania village (Kfar Rehania) | – | Other: NONE interventionCircassian community |
| Kama village (Kfar Kama ) | – | Other: NONE interventionCircassian community |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Circassians in Israel
Key inclusion criteria (1 listed)
- Previous participation in similar study which was occured 10 years ago
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NONE interventionNONE intervention | Other | Kama village (Kfar Kama ), Rehania village (Kfar Rehania) |
Primary outcome
New incidences of Type II Diabetes Mellitus in Circassians minority in Israel
Time frame: 14 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Type II, run by Ziv Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Osamah Hussein, MD (+972 505324913, osama.h@ziv.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New incidences of Type II Diabetes Mellitus in Circassians minority in Israel (time frame: 14 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2013.