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

Active, not recruiting

• Conditions: Obesity, Childhood

• Registration Number: NCT04260048
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-07
• Study Start: 2020-02-21
• Primary Completion: 2024-03-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (2)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

University of Washington; 🇺🇸 Seattle, Washington, United States