Clinical trial NCT03500484: 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
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Obesity, Childhood
Neural Development
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 15 control and 30 obese subjects
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Brain Response in Obese Young Adults Who Drink Sugar Sweetened Beverages.
timeFrame: 1 week
measure: Change in Brain Response in Obese Young Adults Who Drink Sugar Sweetened Beverages.
timeFrame: 1 week and 12 weeks
Secondary outcomes:
Other outcomes:
measure: To Investigate the Role of Specific Metabolic/Hormonal Responses in the Setting of Liraglutide Treatment, in Affecting Neural Responses to Sugar Ingestion.
timeFrame: 1 week and 12 weeks
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Ania Jastreboff, Phd,MD
role: PRINCIPAL_INVESTIGATOR
References: