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

NCT ID: NCT04260048

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-21

Study Completion Date

2024-05-30

Brief Summary

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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

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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.

Conditions

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Obesity, Childhood

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal weight

Group defined based on BMI percentile for age and sex.

No interventions assigned to this group

Overweight

Group defined based on BMI percentile for age and sex.

No interventions assigned to this group

With obesity

Group defined based on BMI percentile for age and sex.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Ellen Schur, MD, MS

Associate Professor, School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ellen A Schur, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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1R01DK117623-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SITE00000078

Identifier Type: -

Identifier Source: org_study_id

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