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

NCT03500484 | Terminated Early Phase 1 Results DMC FDA Drug

• 1 other identifier: 2000022407
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity, Childhood; Neural Development

Outcome Measures

Primary Outcomes (2)

• 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), increase in cerebral blood flow was monitored in participants as a binary outcome (increase/no increase).

  1 week

• Change in 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). Measurement at 1 week was compared to measurement at 12 weeks. Increased blood flow in thalamus was monitored in participants as a binary outcome (increase/no increase).

  1 week and 12 weeks

Other Outcomes (1)

• To Investigate the Role of Specific Metabolic/Hormonal Responses in the Setting of Liraglutide Treatment, in Affecting Neural Responses to Sugar Ingestion.

  1 week and 12 weeks

Study Arms (2)

obese subjects

EXPERIMENTAL

Subjects will self-administer Liraglutide once daily for 12 weeks.

Drug: Liraglutide

lean subjects

NO INTERVENTION

no intervention

Interventions

Liraglutide DRUG

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.

Also known as: Glucagon-like peptide 1

obese subjects

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Liraglutide; Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Ania Jastreboff, MD, PhD
• Organization: Yale University / Yale School of Medicine

ania.jastreboff@yale.edu

203 737 1932

Study Officials

• Ania Jastreboff, Phd,MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 15 control and 30 obese subjects

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 18, 2018
• Study Start: June 6, 2018
• Primary Completion: June 25, 2020
• Study Completion: June 25, 2020
• Last Updated: July 16, 2024
• Results First Posted: July 16, 2024

Record last verified: 2024-07

Locations

US (1)