Trial · Interventional

TerminatedEarly phase 1Results postedRegistry data

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

NCTNCT03500484Other id2000022407

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: The study was initially paused due to COVID restrictions and then when able to resume, there was no longer funding.

Results were posted for this trial.

Overview

Status: Terminated
Phase: Early phase 1
Enrollment: 13 participants (actual)
Sponsor: Yale University · Other
Design: Randomized · Single masking
Countries: 1 country
United States
Start: 6 Jun 2018
Primary completion: 25 Jun 2020
Completion: 25 Jun 2020
First posted: 18 Apr 2018
Last update posted: 16 Jul 2024
Conditions: Obesity, Childhood · Neural Development

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2018201920202021

Ph Early 1
Effect of Liraglutide on Neural Responses to High Fructose Corn Syrup in Individuals With Obesity.
NCT03500484
6 Jun 2018 to 25 Jun 2020
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

LiraglutideDrug

Arms2

Experimental
obese subjects
Subjects will self-administer Liraglutide once daily for 12 weeks.
No intervention
lean subjects
no intervention

Primary outcomes2

Outcomes the sponsor listed as primary.

Brain Response in Obese Young Adults Who Drink Sugar Sweetened Beverages.
Time frame · 1 week
Registry description
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).
Change in Brain Response in Obese Young Adults Who Drink Sugar Sweetened Beverages.
Time frame · 1 week and 12 weeks
Registry description
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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 1 week

Brain Response in Obese Young Adults Who Drink Sugar Sweetened Beverages.

Group	Value (Participants)
Participants With Obesity	8
Participants Who Are Lean	0

Primary outcomeCount of participants· 1 week and 12 weeks

Change in Brain Response in Obese Young Adults Who Drink Sugar Sweetened Beverages.

Group	Value (Participants)
Participants With Obesity	0

Secondary and other outcome results(1)

Other pre specified outcomeMean· 1 week and 12 weeks

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

Group	Value (Index)	Spread
Participants With Obesity	3.54	2.05

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Participants With ObesitySubjects self-administer Liraglutide once daily for 12 weeks. Liraglutide: Liraglutide 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.	0 / 8	0 / 8	3 / 8
Participants Who Are Leanno intervention	0 / 5	0 / 5	0 / 5

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 39 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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.

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