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

Yale University

Status and phase: Terminated; Early Phase 1

Conditions: Obesity, Childhood; Neural Development

Treatments: Drug: Liraglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT03500484

2000022407

Details and patient eligibility

About

To study the effects of liraglutide on neural responses to high fructose corn syrup (HFCS) in individuals with obesity.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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13 participants in 2 patient groups

obese subjects

Experimental group

Description:

Subjects will self-administer Liraglutide once daily for 12 weeks.

Treatment:

Drug: Liraglutide

lean subjects

No Intervention group

Description:

no intervention