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

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

Detailed Description
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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.

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

Conditions
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Obesity, Childhood, Neural Development

Intervention / Treatment
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* Drug: Liraglutide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-39 years old Lean (BMI 18.5-24.9 kg/m2) with normoglycemia Obese (BMI 30-45 kg/m2) with or without prediabetes Weight stable Right handed Able to read and write in English Able to provide written and verbal informed consent Exclusion Criteria: Current active participation in a weight loss program or weight loss of >=10% of total body weight during the previous 6 months Prior bariatric surgery or current gastric balloon Weight >440lbs or waist circumference >142cm Following a vegetarian/vegan diet or dieting/restricting food Significant medical condition Current use of weight-loss medications or supplements, psychiatric medications or anti- hyperglycemic medications History of or family history of multiple endocrine neoplasia type 1 (MEN-I) or medullary thyroid cancer, alcoholism, or previous history of pancreatitis Females who are pregnant or lactating, or who are unwilling to use proper contraception or remain abstinent, Claustrophobia that would interfere with MRI or metal in their body that would pose a risk in the MRI.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 15 control and 30 obese subjects
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |