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Brain Activation and Satiety in Children 2 (BASIC2)

Primary Purpose

Childhood Obesity

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Family Based Behavioral Treatment

Exenatide 2 mg [Bydureon]

Placebo

About this trial

This is an interventional treatment trial for Childhood Obesity

Eligibility Criteria

10 Years - 12 Years (Child)All SexesDoes not accept healthy 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

Sites / Locations

Seattle Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Exenatide once weekly extended-release

Matching placebo

Arm Description

Weekly subcutaneous injections of glucagon-like peptide (GLP)-1 agonist exenatide once weekly extended-release (2mg) for 24 weeks in randomized intervention.

Weekly subcutaneous injections of placebo for 24 weeks.

Outcomes

Primary Outcome Measures

Change of BMI z-score

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

BMI z-score

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

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

Indices of metabolic syndrome

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

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

Full Information

NCT ID

NCT04520490

First Posted

July 31, 2020

Last Updated

July 6, 2023

Sponsor

Seattle Children's Hospital

Collaborators

University of Washington

1. Study Identification

Unique Protocol Identification Number

NCT04520490

Brief Title

Brain Activation and Satiety in Children 2

Acronym

BASIC2

Official Title

Brain Systems and Behaviors Underlying Response to Obesity Treatment in Children

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 28, 2021 (Actual)

Primary Completion Date

November 30, 2023 (Anticipated)

Study Completion Date

August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seattle Children's Hospital

Collaborators

University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Childhood Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Exenatide once weekly extended-release

Arm Type

Active Comparator

Arm Description

Weekly subcutaneous injections of glucagon-like peptide (GLP)-1 agonist exenatide once weekly extended-release (2mg) for 24 weeks in randomized intervention.

Arm Title

Matching placebo

Arm Type

Placebo Comparator

Arm Description

Weekly subcutaneous injections of placebo for 24 weeks.

Intervention Type

Behavioral

Intervention Name(s)

Family Based Behavioral Treatment

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Exenatide 2 mg [Bydureon]

Other Intervention Name(s)

Bydureon®

Intervention Description

Weekly injections of active drug.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Weekly placebo injections

Primary Outcome Measure Information:

Title

Change of BMI z-score

Description

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.

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

Secondary Outcome Measure Information:

Title

BMI z-score

Description

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.

Time Frame

Up to 12-months after ending treatment

Title

Body composition

Description

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

Time Frame

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

Title

Indices of metabolic syndrome

Description

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

Time Frame

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

Title

Meal induced chances in brain activation to visual food cues

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christian L Roth, MD

Phone

206-987-5428

christian.roth@seattlechildrens.org

First Name & Middle Initial & Last Name or Official Title & Degree

Clinton T Elfers

Phone

206-884-1256

clinton.elfers@seattlechildrens.org

Facility Information:

Facility Name

Seattle Children's Hospital

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clinton T Elfers

Phone

206-884-1256

clinton.elfers@seattlechildrens.org

First Name & Middle Initial & Last Name & Degree

Christian L Roth, MD

12. IPD Sharing Statement

Plan to Share IPD

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