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Completed

NCT Number: NCT04260048

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

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.

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Key information

Conditions

Obesity, Childhood Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

9 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins University, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Hypothalamic gliosis

    Time frame: 2 years

    Evidence of hypothalamic gliosis as measured by T2 relaxation time using MRI

  2. Habitual dietary intake

    Time frame: 2 years

    Dietary intake in children by 24-hour dietary recalls

  3. Obesity

    Time frame: 2 years

    Child BMI z-score calculated by the measures of height and weight

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Johns Hopkins University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Feb 7, 2020
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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