Diabetes MellitusNCT01402362
Prevalence of Glucose Intolerance and Risk Factors in Ethiopian Immigrants in Israel; Follow-up Study.
An observational study of Diabetes Mellitus and Glucose Intolerance, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
High risk population: Screening for impaired glucose tolerance. Read more about this study
- Who is it for?
- Ages 25 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Glucose Intolerance
- How many people
- 550 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2011to not given
- 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 25 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ethiopian immigrants to Israel living in Hadera.
Who may be able to join
- Participation in the year 2000 study
- Signature of Informed Consent Form
Who cannot join
- Pregnancy
- -
Trial locations and contacts
1 site in 1 country.
Israel1 site
Diabetes and Endocrinology Unit, Hillel Yaffe MC, POB169
Hadera, 38100
Anat Jaffe, MD PhD, +97246304748, jaffe@hy.health.gov.il
Liana Tripto, MD
About this study
High risk population: Screening for impaired glucose tolerance.
- Conditions
- Diabetes Mellitus, Glucose Intolerance
- Keywords
- Ethiopians, Diabetes Mellitus, Glucose tolerance, Israel, Included in the year 2000 study
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ethiopians participating in previous study, year 2000 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients with Diabetes Mellitus or impaired glucose tolerance
Measured: Day 1 of study
Secondary outcomes (1)
Prevalence of hypertension and hyperlipidemia
Measured: Day 1 of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402362
- Sponsor's protocol ID
- 56-2011
- Status last verified
- Jun 2011
- First submitted
- 24 Jul 2011
- Last updated
- 26 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Glucose Intolerance and Risk Factors in Ethiopian Immigrants in Israel; Follow-up Study.
- ClinicalTrials.gov ID
- NCT01402362
- Acronym / sponsor ID
- 56-2011
- Conditions
- Diabetes Mellitus, Glucose Intolerance
- Keywords
- Ethiopians, Diabetes Mellitus, Glucose tolerance, Israel, Included in the year 2000 study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Sep 2011
- First posted
- 26 Jul 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.
High risk population: Screening for impaired glucose tolerance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ethiopians participating in previous study, year 2000 | – | – |
Who may qualify
- Ages
- 25 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ethiopian immigrants to Israel living in Hadera.
Key inclusion criteria (2 listed)
- Participation in the year 2000 study
- Signature of Informed Consent Form
Key exclusion criteria (2 listed)
- Pregnancy
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent of patients with Diabetes Mellitus or impaired glucose tolerance
Time frame: Day 1 of study
1 secondary outcome
Prevalence of hypertension and hyperlipidemia
Time frame: Day 1 of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2011.
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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 and Glucose Intolerance, run by Hillel Yaffe Medical Center 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 2 inclusion and 2 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 26 Jul 2011. 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 Anat Jaffe, MD PhD (+97246304748, Jaffe@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of patients with Diabetes Mellitus or impaired glucose tolerance (time frame: Day 1 of study). 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 26 Jul 2011.