Back to resultsEffect of Liraglutide on Neural Responses to High Fructose Corn Syrup in Individuals With Obesity.
Primary Purpose
Obesity, Childhood, Neural Development
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Liraglutide
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Childhood
Eligibility Criteria
Inclusion Criteria:
- 18-39 years old
- Lean (BMI 18.5-24.9 kg/m2) with normoglycemia
- Obese (BMI 30-45 kg/m2) with or without prediabetes
- Weight stable
- Right handed
- Able to read and write in English
- Able to provide written and verbal informed consent
Exclusion Criteria:
- Current active participation in a weight loss program or weight loss of >=10% of total body weight during the previous 6 months
- Prior bariatric surgery or current gastric balloon
- Weight >440lbs or waist circumference >142cm
- Following a vegetarian/vegan diet or dieting/restricting food
- Significant medical condition
- Current use of weight-loss medications or supplements, psychiatric medications or anti- hyperglycemic medications
- History of or family history of multiple endocrine neoplasia type 1 (MEN-I) or medullary thyroid cancer, alcoholism, or previous history of pancreatitis
- Females who are pregnant or lactating, or who are unwilling to use proper contraception or remain abstinent,
- Claustrophobia that would interfere with MRI or metal in their body that would pose a risk in the MRI.
Sites / Locations
- Yale University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
obese subjects
lean subjects
Arm Description
Subjects will self-administer Liraglutide once daily for 12 weeks.
no intervention
Outcomes
Primary Outcome Measures
To investigate brain response in obese young adults who drink sugar sweetened beverages.
To investigate brain response (using fMRI) to acute consumption of sugar sweetened beverages in obese prediabetic adolescents/young adults (age 18-39 yrs).
To investigate brain response in obese young adults who drink sugar sweetened beverages.
To investigate brain response (using fMRI) to acute consumption of sugar sweetened drinks in obese prediabetic adolescents/young adults (age 18-39 yrs).
Secondary Outcome Measures
To investigate the effect of liraglutide on neural responses.
To investigate the effect of neural responses in obese prediabetic adolescents/young adults.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03500484
Brief Title
Effect of Liraglutide on Neural Responses to High Fructose Corn Syrup in Individuals With Obesity.
Official Title
Effect of Liraglutide on Neural Responses to High Fructose Corn Syrup in Individuals With Obesity.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
June 6, 2018 (Actual)
Primary Completion Date
June 25, 2020 (Actual)
Study Completion Date
June 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To study the effects of liraglutide on neural responses to high fructose corn syrup (HFCS) in individuals with obesity.
Detailed Description
Adolescents are the highest consumers of sugar sweetened beverages (SSB) potentially because their developing brains are most susceptible to the rewarding neural effects of sugar consumption. Thus, we specifically target this population (adolescents) to understand neural mechanisms involved in excess sugar consumption which predisposes to the development of obesity, prediabetes, and type 2 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood, Neural Development
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
15 control and 30 obese subjects
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
obese subjects
Arm Type
Experimental
Arm Description
Subjects will self-administer Liraglutide once daily for 12 weeks.
Arm Title
lean subjects
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Other Intervention Name(s)
Glucagon-like peptide 1
Intervention Description
Liraglutide will be supplied in the following package sizes containing disposable, pre-filled, multidose pens. Each individual pen delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3 mg (6 mg/mL, 3 mL). Liraglutide will be self-administered daily for 12 weeks under the following regimen: 0.6mg for 1 week, 1.2mg for 1 week, 1.8mg for 1 week, 2.4mg for 1 week, 3.0mg until week 12.
Primary Outcome Measure Information:
Title
To investigate brain response in obese young adults who drink sugar sweetened beverages.
Description
To investigate brain response (using fMRI) to acute consumption of sugar sweetened beverages in obese prediabetic adolescents/young adults (age 18-39 yrs).
Time Frame
1 week
Title
To investigate brain response in obese young adults who drink sugar sweetened beverages.
Description
To investigate brain response (using fMRI) to acute consumption of sugar sweetened drinks in obese prediabetic adolescents/young adults (age 18-39 yrs).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
To investigate the effect of liraglutide on neural responses.
Description
To investigate the effect of neural responses in obese prediabetic adolescents/young adults.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
To investigate the role of specific metabolic/hormonal responses in the setting of liraglutide treatment, in affecting neural responses to sugar ingestion.
Description
To investigate the role of specific metabolic/hormonal responses in the setting of liraglutide treatment, in affecting neural responses to sugar ingestion.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18-39 years old
Lean (BMI 18.5-24.9 kg/m2) with normoglycemia
Obese (BMI 30-45 kg/m2) with or without prediabetes
Weight stable
Right handed
Able to read and write in English
Able to provide written and verbal informed consent
Exclusion Criteria:
Current active participation in a weight loss program or weight loss of >=10% of total body weight during the previous 6 months
Prior bariatric surgery or current gastric balloon
Weight >440lbs or waist circumference >142cm
Following a vegetarian/vegan diet or dieting/restricting food
Significant medical condition
Current use of weight-loss medications or supplements, psychiatric medications or anti- hyperglycemic medications
History of or family history of multiple endocrine neoplasia type 1 (MEN-I) or medullary thyroid cancer, alcoholism, or previous history of pancreatitis
Females who are pregnant or lactating, or who are unwilling to use proper contraception or remain abstinent,
Claustrophobia that would interfere with MRI or metal in their body that would pose a risk in the MRI.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ania Jastreboff, Phd,MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
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Effect of Liraglutide on Neural Responses to High Fructose Corn Syrup in Individuals With Obesity.
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