Trial Outcomes & Findings for Effect of Liraglutide on Neural Responses to High Fructose Corn Syrup in Individuals With Obesity. (NCT NCT03500484)
NCT ID: NCT03500484
Last Updated: 2024-07-16
Results Overview
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).
TERMINATED
EARLY_PHASE1
13 participants
1 week
2024-07-16
Participant Flow
Participant milestones
| Measure |
Participants With Obesity
Subjects self-administer Liraglutide once daily for 12 weeks.
Liraglutide: Liraglutide 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 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.
|
Participants Who Are Lean
no intervention
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
5
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Participants With Obesity
Subjects self-administer Liraglutide once daily for 12 weeks.
Liraglutide: Liraglutide 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 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.
|
Participants Who Are Lean
no intervention
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Could not be scanned or followed up due to COVID
|
1
|
0
|
Baseline Characteristics
Effect of Liraglutide on Neural Responses to High Fructose Corn Syrup in Individuals With Obesity.
Baseline characteristics by cohort
| Measure |
Obese Subjects
n=8 Participants
Subjects will self-administer Liraglutide once daily for 12 weeks.
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.
|
Lean Subjects
n=5 Participants
no intervention
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26 years
STANDARD_DEVIATION 5.5 • n=39 Participants
|
21.2 years
STANDARD_DEVIATION 1.9 • n=41 Participants
|
24.2 years
STANDARD_DEVIATION 5 • n=35 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
African American
|
3 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=39 Participants
|
5 participants
n=41 Participants
|
13 participants
n=35 Participants
|
|
Years of Education
|
14 years
STANDARD_DEVIATION 2.9 • n=39 Participants
|
15 years
STANDARD_DEVIATION 1.8 • n=41 Participants
|
14 years
STANDARD_DEVIATION 2.6 • n=35 Participants
|
PRIMARY outcome
Timeframe: 1 weekTo 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).
Outcome measures
| Measure |
Participants With Obesity
n=8 Participants
Subjects self-administer Liraglutide once daily for 12 weeks.
Liraglutide: Liraglutide 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.
|
Participants Who Are Lean
n=5 Participants
no intervention
|
|---|---|---|
|
Brain Response in Obese Young Adults Who Drink Sugar Sweetened Beverages.
Increase in cerebral blood flow in the caudate, putamen and insula
|
8 Participants
|
0 Participants
|
|
Brain Response in Obese Young Adults Who Drink Sugar Sweetened Beverages.
No increase in cerebral blood flow in the caudate, putamen and insula
|
0 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 1 week and 12 weeksPopulation: 12 week follow up only took place in participants with obesity in matched cases.
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).
Outcome measures
| Measure |
Participants With Obesity
n=4 Participants
Subjects self-administer Liraglutide once daily for 12 weeks.
Liraglutide: Liraglutide 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.
|
Participants Who Are Lean
no intervention
|
|---|---|---|
|
Change in Brain Response in Obese Young Adults Who Drink Sugar Sweetened Beverages.
Increased blood flow in thalamus at 1 week
|
0 Participants
|
—
|
|
Change in Brain Response in Obese Young Adults Who Drink Sugar Sweetened Beverages.
Increased blood flow in thalamus at 12 weeks
|
4 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 week and 12 weeksPopulation: 12 week follow up only took place in participants with obesity in matched cases.
To investigate the role of specific metabolic/hormonal responses in the setting of liraglutide treatment, in affecting neural responses to sugar ingestion. Metabolic response is represented by the whole-body insulin sensitivity index (WBISI). The Oral Glucose Tolerance Test (OGTT) were performed at Baseline and Week 12. Insulin Sensitivity was measured by obtaining glucose and insulin levels in a fasting state and at 2 hours after administration of oral glucose load. Matsuda index = 10,000/SQRT \[glucose concentration (mg/dL) (fasting)\*insulin concentration (uIU/mL) (fasting)\*glucose concentration (mg/dL) (2 hours after glucose load)\*insulin concentration (uIU/mL) (2 hours after glucose load)\], with higher numbers indicating better insulin sensitivity.
Outcome measures
| Measure |
Participants With Obesity
n=4 Participants
Subjects self-administer Liraglutide once daily for 12 weeks.
Liraglutide: Liraglutide 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.
|
Participants Who Are Lean
no intervention
|
|---|---|---|
|
To Investigate the Role of Specific Metabolic/Hormonal Responses in the Setting of Liraglutide Treatment, in Affecting Neural Responses to Sugar Ingestion.
1 Week
|
3.54 Index
Standard Deviation 2.05
|
—
|
|
To Investigate the Role of Specific Metabolic/Hormonal Responses in the Setting of Liraglutide Treatment, in Affecting Neural Responses to Sugar Ingestion.
12 Weeks
|
4.08 Index
Standard Deviation 3.58
|
—
|
Adverse Events
Participants With Obesity
Participants Who Are Lean
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Participants With Obesity
n=8 participants at risk
Subjects 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.
|
Participants Who Are Lean
n=5 participants at risk
no intervention
|
|---|---|---|
|
Gastrointestinal disorders
gastrointestinal side effects and patient dx with sarcoidosis
|
12.5%
1/8 • Number of events 1 • 12-16 weeks
definition used do not differ from clinicaltrials.gov
|
0.00%
0/5 • 12-16 weeks
definition used do not differ from clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
rash near injection area
|
25.0%
2/8 • Number of events 2 • 12-16 weeks
definition used do not differ from clinicaltrials.gov
|
0.00%
0/5 • 12-16 weeks
definition used do not differ from clinicaltrials.gov
|
Additional Information
Ania Jastreboff, MD, PhD
Yale University / Yale School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place