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

Obesity, Childhood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04260048
• Other study ID #: SITE00000078
• Secondary ID: 1R01DK117623-01A
• Status: Active, not recruiting
• Start date: February 21, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Gliosis
• Obesity
• Obesity, Childhood
• Pediatric Obesity

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Johns Hopkins University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

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