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

NCT04260048 | Completed

• 2 other identifiers: SITE000000781R01DK117623-01A1
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 9 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Johns Hopkins University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Permission to obtain and store a sample of whole blood to look at DNA in the future will be made.

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Ellen A Schur, MD, MS

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Medicine

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: February 7, 2020
• Study Start: February 21, 2020
• Primary Completion: March 28, 2024
• Study Completion: May 30, 2024
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)