Brain Activation and Satiety in Children 2

• Status: Recruiting
• Trial end date: 2024-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seattle Children's Hospital
• Collaborator: University of Washington
• Treatments: Exenatide

Criteria

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