Clinical trial NCT04260048: Impact of Hypothalamic Gliosis on Appetite Regulation and Obesity Risk in Children
Official title: Impact of Hypothalamic Gliosis on Appetite Regulation and Obesity Risk in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Childhood
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-02-07
Enrollment: 101
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hypothalamic gliosis
timeFrame: 2 years
measure: Habitual dietary intake
timeFrame: 2 years
measure: Obesity
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Ellen A Schur, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: