NCT01535105

Brief 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 years, among high risk diabetes prone population, for diagnosis and treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

March 14, 2013

Status Verified

February 1, 2012

Enrollment Period

8 months

First QC Date

February 14, 2012

Last Update Submit

March 13, 2013

Conditions

Glucose Metabolism Disorders

Outcome Measures

Primary Outcomes (1)

  • Frequency of Impaired Glucose Homeostasis among obese adolescents in high risk diabetes prone population

    one year

Secondary Outcomes (1)

  • Description of the metabolic profile in obese adolescents

    One year

Study Arms (1)

Obese Adolescents

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects of the study will be selected from a primary care clinic

You may qualify if:

  • Clinical diagnosis of obesity

You may not qualify if:

  • History of disease or drug therapy affecting glucose metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clalit Health Services Clinic

Jisr az-Zarqa Village, Israel

RECRUITING

MeSH Terms

Conditions

Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Nehama Zuckerman-Levin, MD

    Clalit Health Services

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nehama Zuckerman-Levin, MD

CONTACT

972-524354143zuckerln@netvision.net.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2012

First Posted

February 17, 2012

Study Start

August 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2017

Last Updated

March 14, 2013

Record last verified: 2012-02

Locations

IL(1)