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

Sponsor
Yale University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03500484
Collaborator
(none)
45
Enrollment
1
Location
2
Arms
82.8
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
15 control and 30 obese subjects15 control and 30 obese subjects
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of Liraglutide on Neural Responses to High Fructose Corn Syrup in Individuals With Obesity.
Actual Study Start Date :
Jun 6, 2018
Anticipated Primary Completion Date :
Apr 30, 2025
Anticipated Study Completion Date :
Apr 30, 2025

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. To investigate brain response in obese young adults who drink sugar sweetened beverages. [1 week]

      To investigate brain response (using fMRI) to acute consumption of sugar sweetened beverages in obese prediabetic adolescents/young adults (age 18-39 yrs).

    2. To investigate brain response in obese young adults who drink sugar sweetened beverages. [12 weeks]

      To investigate brain response (using fMRI) to acute consumption of sugar sweetened drinks in obese prediabetic adolescents/young adults (age 18-39 yrs).

    Secondary Outcome Measures

    1. To investigate the effect of liraglutide on neural responses. [12 weeks]

      To investigate the effect of neural responses in obese prediabetic adolescents/young adults.

    Other Outcome Measures

    1. To investigate the role of specific metabolic/hormonal responses in the setting of liraglutide treatment, in affecting neural responses to sugar ingestion. [12 weeks]

      To investigate the role of specific metabolic/hormonal responses in the setting of liraglutide treatment, in affecting neural responses to sugar ingestion.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 39 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yale University New Haven Connecticut United States 06511

    Sponsors and Collaborators

    • Yale University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yale University
    ClinicalTrials.gov Identifier:
    NCT03500484
    Other Study ID Numbers:
    • 2000022407
    First Posted:
    Apr 18, 2018
    Last Update Posted:
    Nov 3, 2021
    Last Verified:
    Nov 1, 2021
    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
    Additional relevant MeSH terms:
    Obesity
    Pediatric Obesity
    Liraglutide
    Glucagon
    Glucagon-Like Peptide 1

    Study Results

    No Results Posted as of Nov 3, 2021