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

Obesity, Childhood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03500484
• Other study ID #: 2000022407
• Status: Completed
• Phase: Phase 2
• Start date: June 6, 2018
• Est. completion date: June 25, 2020

Study information

• Verified date: December 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 25, 2020
• Est. primary completion date: June 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neural Development
• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

Drug:
• Liraglutide
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.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To investigate the role of specific metabolic/hormonal responses in the setting of liraglutide treatment, in affecting neural responses to sugar ingestion.	To investigate the role of specific metabolic/hormonal responses in the setting of liraglutide treatment, in affecting neural responses to sugar ingestion.	12 weeks
Primary	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).	1 week
Primary	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).	12 weeks
Secondary	To investigate the effect of liraglutide on neural responses.	To investigate the effect of neural responses in obese prediabetic adolescents/young adults.	12 weeks