Impact of Hypothalamic Gliosis on Appetite Regulation and... | NCT04260048

Studies
Impact of Hypothalamic Gliosis on Appetite Regulation and Obesity Risk in Children

NCT04260048

Sponsor

University of Washington

Status

Completed

Last Update Posted

May 25, 2025Actual

Enrollment

101Actual

Phase

Not provided

Conditions

Obesity, Childhood

Interventions

Not provided

Countries

United States

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

ID	Type	Description	Link
1R01DK117623-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 21, 2020Actual

Primary Completion Date

Mar 28, 2024Actual

Completion Date

May 30, 2024Actual

First Submitted Date

Jan 28, 2020

First Submission Date that Met QC Criteria

Feb 4, 2020

First Posted Date

Feb 7, 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

May 23, 2025

Last Update Posted Date

May 25, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ellen Schur, MD, MS, Associate Professor, School of Medicine, University of WashingtonPrincipal Investigator

Lead Sponsor

University of WashingtonOTHER

Collaborators

Name	Class
Johns Hopkins University	OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

BEAM is a multi-site longitudinal cohort study of hypothalamic gliosis, central regulation of appetite and weight gain in children. Participants will be recruited from the community in the greater Seattle and greater Baltimore area. All participants will consent to enroll in the 24-month study during which they will complete 5 in-person study visits.

Detailed Description

The proposed 2-site research study uses a longitudinal cohort design in 102 children aged 9-11 yr. It will include for all participants baseline MRI and functional MRI, in-depth eating behavior testing, and measurement of hormone profiles. Serial measurement of weight and self-reported eating habits will occur over 2 yr, with a repeated MRI at 2 yr. The study aims to: 1) test if MBH gliosis is associated with impaired intake regulation and poor weight outcomes over 2 yr in children, 2) determine if CNS appetitive processing is negatively affected when evidence of MBH gliosis is present, and 3) test for other brain regions in which gliosis is present in association with excess adiposity in children. An exploratory aim will assess changes in gliosis in children over 2 yr and their relation to changes in body weight and adiposity.

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

101Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal weight		Group defined based on BMI percentile for age and sex.
Overweight		Group defined based on BMI percentile for age and sex.
With obesity		Group defined based on BMI percentile for age and sex.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hypothalamic gliosis	Evidence of hypothalamic gliosis as measured by T2 relaxation time using MRI	2 years
Habitual dietary intake	Dietary intake in children by 24-hour dietary recalls	2 years
Obesity	Child BMI z-score calculated by the measures of height and weight	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

9-11 y (at time of enrollment)
BMI ≥ 15th percentile for age and sex

Exclusion Criteria:

Significant Health conditions (e.g., type 2 diabetes)
Documented cognitive disorder
History of major weight loss of 10lbs or more, not due to illness, over the past year
Eating disorder (e.g. anorexia, bulimia)
Current use of medications known to alter appetite, body weight or brain response including: Anti-epileptics; Glucocorticoids; Antipsychotics; Stimulants for ADHD
MRI contraindication (e.g. implanted metal, claustrophobia, inability to fit in MRI scanner)
Weight >330 pounds (MRI limit)
Severe food allergies, vegetarian, or vegan, or unable to eat study foods
Currently in formal weight loss program

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

A total of 102 participants (51 per site), age 9-11 years, will be recruited into 1 of three groups: Lean, Overweight, or Obese based on BMI percentile for age and sex.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ellen A Schur, MD, MS	University of Washington	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins University		Baltimore	Maryland	21287	United States
University of Washington

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D063766	Pediatric Obesity

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided