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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

Tracking Information
First Submitted Date  ICMJE April 9, 2018
First Posted Date  ICMJE April 17, 2018
Last Update Posted Date November 28, 2019
Actual Study Start Date  ICMJE June 6, 2018
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2018)
  • 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).
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2018)
  • To investigate brain perfusion cerebral blood flow in obese young adults who chronically consume sugar sweetened beverages. [ Time Frame: 1 week ]
    To investigate brain perfusion cerebral blood flow (CBF) response (using fMRI) to acute consumption of 75 grams of HFCS drink (60% fructose, 40% glucose) in obese prediabetic adolescents/young adults (age 18-25 yrs) who chronically consume Sugar Sweetened Beverages (SSBs) (≥5 SSBs/week).
  • To investigate brain perfusion cerebral blood flow in obese young adults who chronically consume sugar sweetened beverages. [ Time Frame: 12 weeks ]
    To investigate brain perfusion cerebral blood flow (CBF) response (using fMRI) to acute consumption of 75 grams of HFCS drink (60% fructose, 40% glucose) in obese prediabetic adolescents/young adults (age 18-25 yrs) who chronically consume Sugar Sweetened Beverages (SSBs) (≥5 SSBs/week).
Change History Complete list of historical versions of study NCT03500484 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2018)
  • To investigate the effect of liraglutide (0.6mg) on neural responses to high fructose corn syrup consumption and relate brain responses to changes in dietary sugar intake. [ Time Frame: 1 week ]
    To investigate the effect of 12-week intervention with glucagon-like peptide 1 (GLP-1) analogue (liraglutide 3.0mg) in obese prediabetic adolescents/young adults on neural responses to HFCS drink consumption and relate brain responses to changes in dietary sugar intake.
  • To investigate the effect of liraglutide (1.2mg) on neural responses to high fructose corn syrup consumption and relate brain responses to changes in dietary sugar intake. [ Time Frame: 2 weeks ]
    To investigate the effect of 12-week intervention with GLP-1 analogue (liraglutide 3.0mg) in obese prediabetic adolescents/young adults on neural responses to HFCS drink consumption and relate brain responses to changes in dietary sugar intake.
  • To investigate the effect of liraglutide (1.8mg) on neural responses to high fructose corn syrup consumption and relate brain responses to changes in dietary sugar intake. [ Time Frame: 3 weeks ]
    To investigate the effect of 12-week intervention with GLP-1 analogue (liraglutide 3.0mg) in obese prediabetic adolescents/young adults on neural responses to HFCS drink consumption and relate brain responses to changes in dietary sugar intake.
  • To investigate the effect of liraglutide (2.4mg) on neural responses to high fructose corn syrup consumption and relate brain responses to changes in dietary sugar intake. [ Time Frame: 4 weeks ]
    To investigate the effect of 12-week intervention with GLP-1 analogue (liraglutide 3.0mg) in obese prediabetic adolescents/young adults on neural responses to HFCS drink consumption and relate brain responses to changes in dietary sugar intake.
  • To investigate the effect of liraglutide (3.0mg) on neural responses to high fructose corn syrup consumption and relate brain responses to changes in dietary sugar intake. [ Time Frame: 9 weeks ]
    To investigate the effect of 12-week intervention with GLP-1 analogue (liraglutide 3.0mg) in obese prediabetic adolescents/young adults on neural responses to HFCS drink consumption and relate brain responses to changes in dietary sugar intake.
Current Other Pre-specified Outcome Measures
 (submitted: August 29, 2018)
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.
Original Other Pre-specified Outcome Measures
 (submitted: April 9, 2018)
To investigate the role of specific metabolic/hormonal responses induced by consumption of high fructose corn syrup, and in the setting of liraglutide treatment, in affecting neural responses to high fructose corn syrup ingestion. [ Time Frame: 12 weeks ]
To investigate the role of specific metabolic/hormonal responses (serum leptin, insulin, glucose, GLP-1, acyl-ghrelin) induced by consumption of HFCS, and in the setting of liraglutide treatment, in affecting neural responses (striatal, hypothalamic, PFC) to HFCS ingestion.
 
Descriptive Information
Brief Title  ICMJE Effect of Liraglutide on Neural Responses to High Fructose Corn Syrup in Individuals With Obesity.
Official Title  ICMJE Effect of Liraglutide on Neural Responses to High Fructose Corn Syrup in Individuals With Obesity.
Brief Summary To study the effects of liraglutide on neural responses to high fructose corn syrup (HFCS) in individuals with obesity.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
15 control and 30 obese subjects
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity, Childhood
  • Neural Development
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: obese subjects
    Subjects will self-administer Liraglutide once daily for 12 weeks.
    Intervention: Drug: Liraglutide
  • No Intervention: lean subjects
    no intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 9, 2018)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Mari-Lynet Knight 203-737-4777 diabetes.research@yale.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03500484
Other Study ID Numbers  ICMJE 2000022407
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ania Jastreboff, Phd,MD Yale University
PRS Account Yale University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP