Brain Activation and Satiety in Children 2 (BASIC2)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
63 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Central trial contact
Clinton T Elfers; Christian L Roth, MD
Data sourced from clinicaltrials.gov
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