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

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ClinicalTrials.gov Identifier: NCT03500484
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : November 28, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

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
Obesity, Childhood Neural Development Drug: Liraglutide 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 15 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 : June 6, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

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 Name: Glucagon-like peptide 1

No Intervention: lean subjects
no intervention



Primary Outcome Measures :
  1. To investigate brain response in obese young adults who drink sugar sweetened beverages. [ Time Frame: 1 week ]
    To investigate brain response (using fMRI) to acute consumption of sugar sweetened beverages in obese prediabetic adolescents/young adults (age 18-25 yrs).

  2. To investigate brain response in obese young adults who drink sugar sweetened beverages. [ Time Frame: 12 weeks ]
    To investigate brain response (using fMRI) to acute consumption of sugar sweetened drinks in obese prediabetic adolescents/young adults (age 18-25 yrs).


Secondary Outcome Measures :
  1. To investigate the effect of liraglutide on neural responses. [ Time Frame: 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. [ Time Frame: 12 weeks ]
    To investigate the role of specific metabolic/hormonal responses in the setting of liraglutide treatment, in affecting neural responses to sugar ingestion.



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500484


Contacts
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Contact: Mari-Lynet Knight 203-737-4777 diabetes.research@yale.edu

Locations
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United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06511
Contact: Ania Jastreboff, PhD, MD         
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Ania Jastreboff, Phd,MD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03500484     History of Changes
Other Study ID Numbers: 2000022407
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: November 28, 2019
Last Verified: November 2019

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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:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Liraglutide
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists