Pediatric ObesityNCT04600648
Sweet Taste Responsiveness in Relation to Insulin, Leptin and Adiposity Among Obese Treatment Seeking Children
A study testing Serum insulin level and Serum Leptin test in people with Pediatric Obesity, run by State University of New York at Buffalo.
Trial summary
This study will explore whether a relationship exists between insulin and leptin resistance, sweet taste responsiveness, and adiposity. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Serum insulin level and Serum Leptin test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2018to 2 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient of Children's Healthy Weigh of Buffalo
- ages of 8-14
- If enrolled in the bariatric arm:
- must be scheduled for bariatric surgery prior to enrollment
Who cannot join
- Patients unable to get labs drawn at a Kaleida facility
- Severe hay fever or seasonal allergies within 2 weeks of enrollment
- smoker or are exposed to second-hand smoke at home,
- has been dieting to lose weight within the past 6 months of enrollment
- currently taking any prescription medications that can influence taste or small functions or are pregnant.
- pregnancy
- Bariatric arm patients will be excluded if they fail to have the surgery.
About this study
This study will explore whether a relationship exists between insulin and leptin resistance, sweet taste responsiveness, and adiposity.
Read the detailed description
Compared to healthy weight peers, some reports have shown that they are less sensitive to, or perceptive of, sucrose solutions and sweet foods, whereas others have observed the opposite pattern of findings or no difference at all. Among those seeking weight loss treatment, one investigation found perception and preferences for sweet taste remained unchanged after weight loss, and another observed a decreased ability to distinguish sweet taste from other taste solutions. Given these discrepancies in the literature, the proposed study will explore whether a relationship exists between insulin and leptin resistance, sweet taste responsiveness, and adiposity.
- Conditions
- Pediatric Obesity
- Being tested
- Serum insulin level, Serum Leptin test
- Keywords
- Leptin, Insulin, Sweet Responsiveness, Weight Loss
- Medical subject headings
- Pediatric Obesity, Insulin Resistance, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum insulin levelDiagnostic test
Measure levels before and after weight loss related to bariatric surgery
Serum Leptin testDiagnostic test
Measure levels before and after weight loss related to lifestyle change weight loss
| Study group | Role | What they receive |
|---|---|---|
| Weight loss with bariatric surgery | Active comparator | Patients scheduled to undergo bariatric surgery will be tested pre and post bariatric surgery. Interventions to be measured are serum Insulin and leptin levels, sweet taste responsiveness, body fat percentage, and z-BMI Receives: Diagnostic Test: Serum insulin level |
| Weight Loss | Active comparator | Patients to receive lifestyle weight loss treatment will be tested pre and post bariatric surgery. Interventions to be measured are serum Insulin and leptin levels, sweet taste responsiveness, body fat percentage, and z-BMI Receives: Diagnostic Test: Serum Leptin test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Higher insulin and leptin levels will be associated with lower sweet taste sensitivity and perception, and higher body fat percentage and z-BMI
insulin and leptin levels will be measured at various time points in an attempt to identify if there is a change is taste senses associated with specific variables be associated with lower sweet taste
Measured: to be measured at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start20 Sep 2018
- Primary completion2 Aug 2019
- Study completion2 Aug 2019
Why it stopped: poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Compare the level of insulin, leptin, and sweet taste sensitivity and perception before and after short term weight loss and bariatric surgery
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carroll M. Harmon, MD PhD, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600648
- Sponsor's protocol ID
- 00002306
- Status last verified
- Oct 2020
- First submitted
- 26 Aug 2019
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sweet Taste Responsiveness in Relation to Insulin, Leptin and Adiposity Among Obese Treatment Seeking Children
- ClinicalTrials.gov ID
- NCT04600648
- Acronym / sponsor ID
- 00002306
- Conditions
- Pediatric Obesity
- Keywords
- Leptin, Insulin, Sweet Responsiveness, Weight Loss
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: poor enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 2 Aug 2019 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will explore whether a relationship exists between insulin and leptin resistance, sweet taste responsiveness, and adiposity.
Detailed description
Compared to healthy weight peers, some reports have shown that they are less sensitive to, or perceptive of, sucrose solutions and sweet foods, whereas others have observed the opposite pattern of findings or no difference at all. Among those seeking weight loss treatment, one investigation found perception and preferences for sweet taste remained unchanged after weight loss, and another observed a decreased ability to distinguish sweet taste from other taste solutions. Given these discrepancies in the literature, the proposed study will explore whether a relationship exists between insulin and leptin resistance, sweet taste responsiveness, and adiposity.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Compare the level of insulin, leptin, and sweet taste sensitivity and perception before and after short term weight loss and bariatric surgery
| Arm | Type | Receives |
|---|---|---|
| Weight loss with bariatric surgery | Active comparator | Diagnostic Test: Serum insulin levelPatients scheduled to undergo bariatric surgery will be tested pre and post bariatric surgery. Interventions to be measured are serum Insulin and leptin levels, sweet taste responsiveness, body fat percentage, and z-BMI |
| Weight Loss | Active comparator | Diagnostic Test: Serum Leptin testPatients to receive lifestyle weight loss treatment will be tested pre and post bariatric surgery. Interventions to be measured are serum Insulin and leptin levels, sweet taste responsiveness, body fat percentage, and z-BMI |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patient of Children's Healthy Weigh of Buffalo
- ages of 8-14
- must be scheduled for bariatric surgery prior to enrollment
Key exclusion criteria (7 listed)
- Patients unable to get labs drawn at a Kaleida facility
- Severe hay fever or seasonal allergies within 2 weeks of enrollment
- smoker or are exposed to second-hand smoke at home,
- has been dieting to lose weight within the past 6 months of enrollment
- currently taking any prescription medications that can influence taste or small functions or are pregnant.
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 |
|---|---|---|
| Serum insulin levelMeasure levels before and after weight loss related to bariatric surgery | Diagnostic test | Weight loss with bariatric surgery |
| Serum Leptin testMeasure levels before and after weight loss related to lifestyle change weight loss | Diagnostic test | Weight Loss |
Primary outcome
Higher insulin and leptin levels will be associated with lower sweet taste sensitivity and perception, and higher body fat percentage and z-BMI
Time frame: to be measured at 6 months
insulin and leptin levels will be measured at various time points in an attempt to identify if there is a change is taste senses associated with specific variables be associated with lower sweet taste
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Serum insulin level and Serum Leptin test in people with Pediatric Obesity, run by State University of New York at Buffalo.
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 4 inclusion and 7 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: withdrawn, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Higher insulin and leptin levels will be associated with lower sweet taste sensitivity and perception, and higher body fat percentage and z-BMI (time frame: to be measured at 6 months). 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 26 Jun 2023.