Effect of Liraglutide on Neural Responses to High Fructose Corn Syrup in Individuals With Obesity.

Early Phase 1

Terminated

• Conditions: Obesity, Childhood; Neural Development
• Interventions: Drug: Liraglutide

• Registration Number: NCT03500484
• Lead Sponsor: Yale University

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.

Upon results entry, the data elements in protocol section of this record were updated to reflect the appropriate study phase and primary purpose that was inadvertently mischaracterized at the time of registration. One of the secondary outcomes was removed because it was a duplicate of the second primary outcome.

Study Timeline

• Study First Submitted: 2018-04-09
• Study First Submitted QC: 2018-04-09
• Study First Posted: 2018-04-18
• Study Start: 2018-06-06
• Primary Completion: 2020-06-25
• Study Completion: 2020-06-25
• Results First Submitted: 2023-03-09
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-12
• Last Update Submitted: 2024-07-12
• Results First Posted: 2024-07-16
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

1. 18-39 years old
2. Lean (BMI 18.5-24.9 kg/m2) with normoglycemia
3. Obese (BMI 30-45 kg/m2) with or without prediabetes
4. Weight stable
5. Right handed
6. Able to read and write in English
7. Able to provide written and verbal informed consent

Exclusion Criteria

1. Current active participation in a weight loss program or weight loss of >=10% of total body weight during the previous 6 months
2. Prior bariatric surgery or current gastric balloon
3. Weight >440lbs or waist circumference >142cm
4. Following a vegetarian/vegan diet or dieting/restricting food
5. Significant medical condition
6. Current use of weight-loss medications or supplements, psychiatric medications or anti- hyperglycemic medications
7. History of or family history of multiple endocrine neoplasia type 1 (MEN-I) or medullary thyroid cancer, alcoholism, or previous history of pancreatitis
8. Females who are pregnant or lactating, or who are unwilling to use proper contraception or remain abstinent,
9. Claustrophobia that would interfere with MRI or metal in their body that would pose a risk in the MRI.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
obese subjects	Liraglutide	Subjects will self-administer Liraglutide once daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Brain Response in Obese Young Adults Who Drink Sugar Sweetened Beverages.	1 week and 12 weeks	To investigate brain response (using fMRI) to acute consumption of sugar sweetened drinks in obese prediabetic adolescents/young adults (age 18-39 yrs). Measurement at 1 week was compared to measurement at 12 weeks. Increased blood flow in thalamus was monitored in participants as a binary outcome (increase/no increase).
Brain Response in Obese Young Adults Who Drink Sugar Sweetened Beverages.	1 week	To investigate brain response (using fMRI) to acute consumption of sugar sweetened beverages in obese prediabetic adolescents/young adults (age 18-39 yrs), increase in cerebral blood flow was monitored in participants as a binary outcome (increase/no increase).

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States