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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity, Childhood

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 Type: Observational
• Enrollment (Estimated): 102

Contacts and Locations

• Study Contact: Name: Schur Lab; Phone Number: 206 543-5357; Email: beam@uw.edu
• Study Contact Backup: Name: Schur Lab; Phone Number: 206 616-6360

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Johns Hopkins University; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Ellen A Schur, MD, MS, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2020
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity; Gliosis
• Other Study ID Numbers: SITE00000078; 1R01DK117623-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No