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Brain Activation and Satiety in Children 2 (BASIC2)

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ClinicalTrials.gov Identifier: NCT04520490
Recruitment Status : Recruiting
First Posted : August 20, 2020
Last Update Posted : February 9, 2021
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
Christian L Roth, MD, Seattle Children's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Childhood Obesity Behavioral: Family Based Behavioral Treatment Drug: Exenatide 2 mg [Bydureon] Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brain Systems and Behaviors Underlying Response to Obesity Treatment in Children
Actual Study Start Date : January 28, 2021
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arm Intervention/treatment
Active Comparator: Exenatide once weekly extended-release
Weekly subcutaneous injections of glucagon-like peptide (GLP)-1 agonist exenatide once weekly extended-release (2mg) for 24 weeks in randomized intervention.
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.
Other Name: Bydureon®

Placebo Comparator: Matching placebo
Weekly subcutaneous injections of placebo for 24 weeks.
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: Placebo
Weekly placebo injections




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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)

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04520490


Contacts
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Contact: Christian L Roth, MD 206-987-5428 christian.roth@seattlechildrens.org
Contact: Clinton T Elfers 206-884-1256 clinton.elfers@seattlechildrens.org

Locations
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United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Clinton T Elfers    206-884-1256    clinton.elfers@seattlechildrens.org   
Principal Investigator: Christian L Roth, MD         
Sponsors and Collaborators
Seattle Children's Hospital
University of Washington
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Responsible Party: Christian L Roth, MD, Professor, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT04520490    
Other Study ID Numbers: STUDY00001984
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists