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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04260048
Enrollment
101
Registered
2020-02-07
Start date
2020-02-21
Completion date
2024-05-30
Last updated
2025-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Childhood

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.

Interventions

None listed

Sponsors

Johns Hopkins University
CollaboratorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
9 Years to 11 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Hypothalamic gliosis2 yearsEvidence of hypothalamic gliosis as measured by T2 relaxation time using MRI
Habitual dietary intake2 yearsDietary intake in children by 24-hour dietary recalls
Obesity2 yearsChild BMI z-score calculated by the measures of height and weight

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026