Leipzig Childhood Obesity Study | NCT04491344

Studies
Leipzig Childhood Obesity Study

NCT04491344

Sponsor

University of Leipzig

Status

Recruiting

Last Update Posted

Nov 7, 2023Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Childhood Obesity

Interventions

Not provided

Countries

Germany

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

Nov 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002

Primary Completion Date

Jan 2030Estimated

Completion Date

Jan 2030Estimated

First Submitted Date

Jul 24, 2020

First Submission Date that Met QC Criteria

Jul 24, 2020

First Posted Date

Jul 29, 2020Actual

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

Nov 3, 2023

Last Update Posted Date

Nov 7, 2023Actual

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

The aim of this study is to identify polymorphisms that make children and adolescents more prone to obesity and metabolic dysfunction, as well as to identify biomarkers that are linked to causes and consequences of obesity.

Detailed Description

In order to identify single nucleotide polymorphisms blood and serum samples during oral glucose tolerance testing are routinely obtained from pediatric patients visiting the adiposity outpatient clinic.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

3,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Children with overweight and obesity		Overweight and obese children and adolescents visiting the adiposity outpatient clinic.
adults		follow up of patients into adulthood
control group		matched control group with children, adolescents and aduts without obesity

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gene-dependent association with phenotypical traits in overweight and obese children		20 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all pediatric patients seen in the adiposity outpatient clinic
informed patient consent

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Overweight and obese children and adolescents

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Antje Körner, Prof, MD	Contact	+49 341 97-26500		Antje.Koerner@medizin.uni-leipzig.de
Robert Stein, MD	Contact	+49 341 97-26537		robert.stein@medizin.uni-leipzig.de

Overall Officials

Name	Affiliation	Role
Antje Körner, Prof, MD	University of Leipzig	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Leipzig Medical Center, Department of Women and Child Health, Center for Pediatric Research Leipzig	Recruiting	Leipzig	Saxony	04103	Germany

References Module

Citations

Not provided

Label	URL
Link to the pediatric adiposity outpatient clinic	View source
Link to "Integrated Research and Treatment Center (IFB) Adiposity Diseases, Leipzig"	View source
Link to Prof Antje Körner's Group

ID	Term
D063766	Pediatric Obesity
D009765	Obesity
D007333	Insulin Resistance
D024821	Metabolic Syndrome

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases