Glucose Metabolism DisordersNCT01535105
Impairment in Glucose Homeostasis Among Obese Adolescents in High Risk Diabetes Prone Population - Jisr Az-Zarqa Village
An observational study of Glucose Metabolism Disorders, run by Meir Medical Center at 1 site in Israel.
Trial summary
Obesity is increasing all over the world in adults, adolescents and children,and is followed by morbidity, including the metabolic syndrome. Hypothesis: Among obese adolescents there is a subgroup with impaired glucose homeostasis The aim of the study is to identify adolescents with impaired glucose metabolism, 12-18… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Glucose Metabolism Disorders
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2012to Apr 2017
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subjects of the study will be selected from a primary care clinic
Who may be able to join
- Clinical diagnosis of obesity
Who cannot join
- History of disease or drug therapy affecting glucose metabolism
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Clalit Health Services Clinic
Jisr az-Zarqa Village
Nehama Zuckerman-Levin, MD, 072524354143, zuckerln@netvision.net.il
Nehama Zuckerman-Levin, MD
About this study
Obesity is increasing all over the world in adults, adolescents and children,and is followed by morbidity, including the metabolic syndrome.
Hypothesis: Among obese adolescents there is a subgroup with impaired glucose homeostasis
The aim of the study is to identify adolescents with impaired glucose metabolism, 12-18 years, among high risk diabetes prone population, for diagnosis and treatment.
- Conditions
- Glucose Metabolism Disorders
- Medical subject headings
- Glucose Metabolism Disorders
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 |
|---|---|---|
| Obese Adolescents | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Impaired Glucose Homeostasis among obese adolescents in high risk diabetes prone population
Measured: one year
Secondary outcomes (1)
Description of the metabolic profile in obese adolescents
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2013 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism DisordersStudies 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
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nehama Zuckerman-Levin, MD, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535105
- Sponsor's protocol ID
- Gl homeostasis and obesity
- Status last verified
- Feb 2012
- First submitted
- 14 Feb 2012
- Last updated
- 14 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impairment in Glucose Homeostasis Among Obese Adolescents in High Risk Diabetes Prone Population - Jisr Az-Zarqa Village
- ClinicalTrials.gov ID
- NCT01535105
- Acronym / sponsor ID
- Gl homeostasis and obesity
- Conditions
- Glucose Metabolism Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 17 Feb 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.
Obesity is increasing all over the world in adults, adolescents and children,and is followed by morbidity, including the metabolic syndrome.
Hypothesis: Among obese adolescents there is a subgroup with impaired glucose homeostasis
The aim of the study is to identify adolescents with impaired glucose metabolism, 12-18 years, among high risk diabetes prone population, for diagnosis and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese Adolescents | – | – |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subjects of the study will be selected from a primary care clinic
Key inclusion criteria (1 listed)
- Clinical diagnosis of obesity
Key exclusion criteria (1 listed)
- History of disease or drug therapy affecting glucose metabolism
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
Frequency of Impaired Glucose Homeostasis among obese adolescents in high risk diabetes prone population
Time frame: one year
1 secondary outcome
Description of the metabolic profile in obese adolescents
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 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.
Nehama Zuckerman-Levin, MD principal investigator
Clalit Health Services
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 Glucose Metabolism Disorders, 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 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 14 Mar 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 Nehama Zuckerman-Levin, MD (972-524354143, zuckerln@netvision.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Impaired Glucose Homeostasis among obese adolescents in high risk diabetes prone population (time frame: one year). 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 14 Mar 2013.