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

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

Study Overview

• Status: Completed
• Conditions: Obesity, Childhood; Neural Development
• Intervention / Treatment: Drug: Liraglutide

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: obese subjects; Subjects will self-administer Liraglutide once daily for 12 weeks.	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.; Other Names: Glucagon-like peptide 1
No Intervention: lean subjects; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate the effect of liraglutide on neural responses.	To investigate the effect of neural responses in obese prediabetic adolescents/young adults.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Ania Jastreboff, Phd,MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2018
• Primary Completion (Actual): June 25, 2020
• Study Completion (Actual): June 25, 2020

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: April 9, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity; Hypoglycemic Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide; Glucagon; Glucagon-Like Peptide 1
• Other Study ID Numbers: 2000022407

Drug and device information, study documents

• 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