Impairment in Glucose Homeostasis Among Obese Adolescents... | NCT01535105

Studies
Impairment in Glucose Homeostasis Among Obese Adolescents in High Risk Diabetes Prone Population - Jisr Az-Zarqa Village

NCT01535105

Sponsor

Meir Medical Center

Status

Unknown status

Last Update Posted

Mar 14, 2013Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Glucose Metabolism Disorders

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Apr 2013Estimated

Completion Date

Apr 2017Estimated

First Submitted Date

Feb 14, 2012

First Submission Date that Met QC Criteria

Feb 16, 2012

First Posted Date

Feb 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2013

Last Update Posted Date

Mar 14, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Label	Type	Description	Intervention Names
Obese Adolescents

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of Impaired Glucose Homeostasis among obese adolescents in high risk diabetes prone population		one year

Secondary Outcomes

Measure	Description	Time Frame
Description of the metabolic profile in obese adolescents		One year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of obesity

Exclusion Criteria:

History of disease or drug therapy affecting glucose metabolism

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nehama Zuckerman-Levin, MD	Contact	972-524354143		zuckerln@netvision.net.il

Overall Officials

Name	Affiliation	Role
Nehama Zuckerman-Levin, MD	Clalit Health Services	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clalit Health Services Clinic	Recruiting	Jisr az-Zarqa Village			Israel

Condition Browse Module

MeSH Terms

ID	Term
D044882	Glucose Metabolism Disorders

Ancestor Terms

ID	Term
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided