Ethnic GroupDPEPNCT01659697
Diabetes Prevention in Prediabetic Patients
An observational study of Ethnic Group and Young Adults, run by Meir Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Ethnic Group, Young Adults, Prediabetes
- What is being tested?
- intensive lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2012to Jul 2015
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients aged 25-55 from Ethiopian origin leaving in Israel with pre diabetes
Who may be able to join
- prediabetes
- age 25-55
- ethiopian origin
Who cannot join
- diabetes
- age under 25 or above 55
- non ethiopian origin
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- Ethnic Group, Young Adults, Prediabetes, Community Health Services
- Being tested
- intensive lifestyle counseling
- Keywords
- lifestyle, diabetes prevention, BMI, physical activity
- Medical subject headings
- Prediabetic State, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive lifestyle counselingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intensive Lifestyle counseling | Not described Receives: Behavioral: intensive lifestyle counseling | |
| usual lifestyle counseling | Not described Receives: Behavioral: intensive lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurence of diabetes
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
Measured: two years period
Secondary outcomes (1)
change in Body Mass index and Physical activity
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2014 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ethnic GroupStudies 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Clalit Health Services
- Responsible party
- Sponsor
- Investigators
- Joelle A Singer, M.D., Principal investigator, Meir Medical CenterDalia Blumenthal, M.D., Study director, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659697
- Sponsor's protocol ID
- 057/2012
- Acronym
- DPEP
- Status last verified
- Aug 2012
- First submitted
- 5 Aug 2012
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01659697
- Acronym / sponsor ID
- DPEP / 057/2012
- Conditions
- Ethnic Group, Young Adults, Prediabetes, Community Health Services
- Keywords
- lifestyle, diabetes prevention, BMI, physical activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- Clalit Health Services
- Study start
- Aug 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 8 Aug 2012 (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.
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).
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Lifestyle counseling | – | Behavioral: intensive lifestyle counseling |
| usual lifestyle counseling | – | Behavioral: intensive lifestyle counseling |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients aged 25-55 from Ethiopian origin leaving in Israel with pre diabetes
Key inclusion criteria (3 listed)
- prediabetes
- age 25-55
- ethiopian origin
Key exclusion criteria (3 listed)
- diabetes
- age under 25 or above 55
- non ethiopian origin
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 |
|---|---|---|
| intensive lifestyle counselingIntensive 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 | Behavioural | Intensive Lifestyle counseling, usual lifestyle counseling |
Primary outcome
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
1 secondary outcome
change in Body Mass index and Physical activity
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2012.
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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.
Joelle A Singer, M.D. principal investigator
Meir Medical Center
Dalia Blumenthal, M.D. study director
Meir Medical Center
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 Ethnic Group and Young Adults, run by Meir 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 3 inclusion and 3 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 8 Aug 2012. 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 Joelle S Singer, M.D. (+972506263652, jsinger@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurence of diabetes (time frame: two years period). 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 8 Aug 2012.