Obesity, ChildhoodNCT04260048
Impact of Hypothalamic Gliosis on Appetite Regulation and Obesity Risk in Children
An observational study of Obesity, Childhood, run by University of Washington at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 9 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- How many people
- 101 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Feb 2020to 30 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 9-11 y (at time of enrollment)
- BMI ≥ 15th percentile for age and sex
Who cannot join
- 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)
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- Weight >330 pounds (MRI limit)
- Severe food allergies, vegetarian, or vegan, or unable to eat study foods
- Currently in formal weight loss program
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21287
University of Washington
Seattle, Washington, 98195
About this study
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.
Read the 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.
- Conditions
- Obesity, Childhood
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Hypothalamic gliosis
Evidence of hypothalamic gliosis as measured by T2 relaxation time using MRI
Measured: 2 years
Habitual dietary intake
Dietary intake in children by 24-hour dietary recalls
Measured: 2 years
Obesity
Child BMI z-score calculated by the measures of height and weight
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start21 Feb 2020
- Primary completion28 Mar 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Ellen Schur, MD, MS, University of Washington
- Investigators
- Ellen A Schur, MD, MS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260048
- Sponsor's protocol ID
- SITE00000078
- Other IDs
- 1R01DK117623-01A1
- Status last verified
- May 2025
- First submitted
- 28 Jan 2020
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hypothalamic Gliosis on Appetite Regulation and Obesity Risk in Children
- ClinicalTrials.gov ID
- NCT04260048
- Acronym / sponsor ID
- SITE00000078
- Conditions
- Obesity, Childhood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Johns Hopkins University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 9-11 y (at time of enrollment)
- BMI ≥ 15th percentile for age and sex
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hypothalamic gliosis
Time frame: 2 years
Evidence of hypothalamic gliosis as measured by T2 relaxation time using MRI
Habitual dietary intake
Time frame: 2 years
Dietary intake in children by 24-hour dietary recalls
Obesity
Time frame: 2 years
Child BMI z-score calculated by the measures of height and weight
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen A Schur, MD, MS principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Childhood, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypothalamic gliosis (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.