Obesity, ChildhoodEarly Phase 1NCT03500484
Effect of Liraglutide on Neural Responses to High Fructose Corn Syrup in Individuals With Obesity.
A Early Phase 1 study testing Liraglutide in people with Obesity, Childhood and Neural Development, run by Yale University at 1 site in United States.
Trial summary
To study the effects of liraglutide on neural responses to high fructose corn syrup (HFCS) in individuals with obesity. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood, Neural Development
- What is being tested?
- Liraglutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2018to 25 Jun 2020
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-39 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
To study the effects of liraglutide on neural responses to high fructose corn syrup (HFCS) in individuals with obesity.
Read the 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.
Upon results entry, the data elements in protocol section of this record were updated to reflect the appropriate study phase and primary purpose that was inadvertently mischaracterized at the time of registration. One of the secondary outcomes was removed because it was a duplicate of the second primary outcome.
- Conditions
- Obesity, Childhood, Neural Development
- Being tested
- Liraglutide
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Glucagon-like peptide 1
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.
| Study group | Role | What they receive |
|---|---|---|
| obese subjects | Experimental | Subjects will self-administer Liraglutide once daily for 12 weeks. Receives: Drug: Liraglutide |
| lean subjects | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 1 week and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start6 Jun 2018
- Primary completion25 Jun 2020
- Study completion25 Jun 2020
Why it stopped: The study was initially paused due to COVID restrictions and then when able to resume, there was no longer funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 15 control and 30 obese subjects
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ania Jastreboff, Phd,MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500484
- Sponsor's protocol ID
- 2000022407
- Status last verified
- Jul 2024
- First submitted
- 9 Apr 2018
- Last updated
- 16 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Liraglutide on Neural Responses to High Fructose Corn Syrup in Individuals With Obesity.
- ClinicalTrials.gov ID
- NCT03500484
- Acronym / sponsor ID
- 2000022407
- Conditions
- Obesity, Childhood, Neural Development
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was initially paused due to COVID restrictions and then when able to resume, there was no longer funding.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Posted 16 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Upon results entry, the data elements in protocol section of this record were updated to reflect the appropriate study phase and primary purpose that was inadvertently mischaracterized at the time of registration. One of the secondary outcomes was removed because it was a duplicate of the second primary outcome.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 15 control and 30 obese subjects
| Arm | Type | Receives |
|---|---|---|
| obese subjects | Experimental | Drug: LiraglutideSubjects will self-administer Liraglutide once daily for 12 weeks. |
| lean subjects | No intervention | –no intervention |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-39 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiraglutideAlso: Glucagon-like peptide 1Liraglutide 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. | Drug | obese subjects |
Primary outcome
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 18-39 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
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ania Jastreboff, Phd,MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Liraglutide in people with Obesity, Childhood and Neural Development, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Response in Obese Young Adults Who Drink Sugar Sweetened Beverages. (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.