Current partner codePEPTIDESDE
NCT04520490·Phase 3·INTERVENTIONAL

Brain Activation and Satiety in Children 2

Status

Active, not recruiting

Phase

Phase 3

Enrollment

63

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

Childhood obesity and related long-term effects are serious public health problems, but not all children with obesity do well in treatment. This study will test a new combination of family-based behavioral treatment (FBT) with a drug intervention using a glucagon-like peptide-1 receptor agonist (GLP-1RA) exenatide once weekly extended-release (ExQW, Bydureon®) in order to improve obesity intervention outcomes in 10-12-year-old children.

Full detailed description

Using functional and structural magnetic resonance neuroimaging, this study will evaluate brain factors which could undermine treatment responses and long-term obesity intervention outcomes. Specific Aim 1 will test the effect of adding ExQW to FBT on change in BMI z-score over a total GLP-1RA treatment duration of 24 weeks and a subsequent 1-year observational follow-up period after treatment cessation. To provide mechanistic insight, Specific Aim 2 will test whether adding GLP-1RA intervention to FBT impacts neural activation by food cues. Finally, the proposed research will investigate the role of a cellular inflammatory process in the mediobasal hypothalamus-called gliosis-which might contribute to impaired hypothalamic function, attenuated satiety responsiveness, and potentially to worse weight management outcomes. Specific Aim 3 will test if hypothalamic gliosis is modified by FBT and/or FBT plus GLP-1RA in children and if its extent is related to immediate and/or long-term intervention outcomes. Study Design: This double-blinded, randomized, placebo-controlled research study uses fMRI to characterize neural responses to a test meal before and at the end of FBT intervention, with vs. without additional GLP-1RA intervention. In addition, it uses structural MRI (sMRI) to test if MBH gliosis is reversible and/or associated with intervention outcomes.

Interventions

Treatment arms and agents.

BEHAVIORAL

Family Based Behavioral Treatment

Children with obesity accompanied by at least one parent or caregiver will attend 24 weekly sessions. Most sessions will be held via video-conference and include 25-30 min. meetings between an interventionist and each child/parent pair to individualize treatment, followed by separate child and parent group meetings lasting 40 - 45 min. A select few sessions will be held in-person between an interventionist and each child/parent pair with no group session. Parents will serve as primary agents of change for their child and for themselves. Training will focus on food and physical activity education, parenting around food and physical activity, and use of behavioral skills (e.g., self-monitoring, environmental control, contingency management). Intervention groups of 8-12 children/families will be initiated every 3-6 mos. in study yrs. 2-3.

DRUG

Exenatide 2 mg [Bydureon]

Weekly injections of active drug.

DRUG

Placebo

Weekly placebo injections

Timeline

From registration to results.

  1. First posted

    Aug 20, 2020

  2. Study start

    Jan 28, 2021

  3. Primary completion

    Aug 21, 2025

  4. Study completion

    Feb 12, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jan 5, 2026

Outcomes

What the study measures.

Primary outcomes

Change of BMI z-score

Time frame · Change from drug treatment randomization at week 8 of family-based behavioral treatment (FBT) to end of combined intervention (FBT + drug) at week 24 of FBT

Body mass index (BMI) z-scores will be derived using CDC growth charts, using the LMS method, to allow for comparison of adiposity over time and across children who differ in age and sex.

Secondary outcomes

BMI z-score

Time frame · Up to 12-months after ending treatment

Change of body mass index (BMI) z-scores derived using CDC growth charts, using the LMS method, to allow for comparison of adiposity over time and across children who differ in age and sex.

Body composition

Time frame · Change from Baseline to post-Family Based Behavioral Treatment at week 24 and post drug-treatment at week 32

Changes in body composition as assessed using a bioelectrical impedance (BIA)

Indices of metabolic syndrome

Time frame · Change from Baseline to post-Family Based Behavioral Treatment at week 24

Changes of insulin resistance assessed by fasting insulin used for homeostasis model assessment of insulin resistance (HOMA-IR) using the formula insulin \[mU/l\] x glucose \[mmol/l\]) / 22.5

Meal induced chances in brain activation to visual food cues

Time frame · Change from Baseline to post-Family Based Behavioral Treatment at week 24

Change of brain response to visual food cues measured by functional magnetic resonance imaging in a priori regions of interest

Eligibility

Who can take part.

Minimum age
10 Years
Maximum age
12 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * 10-12 years of age * Male or female * Ability and willingness to participate in study visits including fMRI scans, blood draws, and weekly injections; * Parent willing to provide informed written consent and child willing to provide written assent; * Child has BMI z-score \>95th percentile. for age and sex; * One parent that is obese or overweight (BMI \>27 kg/m2); willingness of 1 parent (does not have to be the parent with obesity) to engage in weekly family-based weight control treatment delivered in English. Exclusion Criteria: * History of acute or chronic serious medical conditions; * known diabetes mellitus or recent (6 mo.) history of anemia; * Presence of any implanted metal or metal devices, including ferro-metallic surgical clips or orthodontic braces; * Claustrophobia; * Documented cognitive disorder, disruptive behavior, inability to participate in group sessions; * Current use of medications known to alter appetite, body weight, or brain response * Food intolerance to test meal (macaroni and cheese) or vegetarianism/veganism or severe food allergies. * Known renal impairment (GFR\<60 ml/min/1.73m2) * History of gastroparesis, pancreatitis or gallstones (unless status post cholecystectomy); * Family history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma; * Known elevated calcitonin level at phone screening or increased measured calcitonin level at study visits; * Untreated thyroid disorder or adrenal insufficiency; * Use of weight loss medications (child participant) within 3 months of screening visit. * Participating parent is pregnant

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Seattle Children's Hospital

Seattle, Washington, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Exenatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.