ObesityPhase 2NCT03497988
Intranasal Oxytocin and Food Intake in Obese Adolescents
A Phase 2 study testing Syntocinon in people with Obesity, run by Shana McCormack, MD.
Trial summary
The purpose of the study is to determine the effect of intranasal OXT caloric intake and eating behaviors in otherwise healthy obese adolescents. The primary objective of this study is to determine the effects of intranasal administration of oxytocin on food intake in obese, pubertal or post-pubertal adolescents (13… Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Obesity
- What is being tested?
- Syntocinon
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to Jun 2021
- Phase
- Phase 2
- 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 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Proficient in English.
- Pubertal or Post-Pubertal Females: 13 to <18 years.
- Pubertal or Post-Pubertal Males: 15 to <20 years.
- Girls must have a negative urine pregnancy test and post-menarchal girls must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.
- Currently obese (BMI >95%ile for age/sex if age < 18 years, BMI > 30 kg/m2 age 18 - 20 years). In children, obesity is defined with respect to age- and sex based as greater than or equal to the 95th%ile1, whereas in adults, an absolute threshold is used.
- Parental/guardian permission (informed consent) and if appropriate, child assent.
Who cannot join
- Diabetes mellitus requiring insulin or insulin secretagogue. (Laboratory values: HgbA1c ≥8.5%)
- Cardiovascular condition, as defined as any of the following: i) abnormal blood pressure, defined as <3%ile or >97%ile for age, sex and height 3, for adult participants abnormal blood pressure is defined as Stage 2 hypertension (systolic BP > 160 mm Hg or diastolic BP > 100 mm Hg); ii) history of cardiac arrhythmia or arrhythmia detected on screening ECG; iii) history of heart failure and/or cardiomyopathy; iv) prolonged QTc interval (QTc > 460 msec), and/or long QT syndrome phenotype and/or positive genotype for long QT syndrome pathogenic mutations.
- Concurrent use of medications known to prolong QTc interval and pose high risk for Torsades de Pointes (TdP) according to the current information available (www.crediblemeds.org). Concomitant medications will be assessed by the Investigational Drug Service (IDS) pharmacist, in collaboration with the study cardiologist, if additional clarification is needed. In addition, we require that potential participants be on a stable dose for at least 2 months of any medication with the potential to alter cardiac rhythm to ensure the screening ECG reflects steady-state physiology.
- Laboratory abnormalities that indicate abnormal sodium level, liver or renal disease, or anemia:
- Sodium - Outside Normal Range; Aspartate Aminotransferase (AST)/SGOT > 3.0 X's Upper Limit of Normal (ULN); Alanine Aminotransferase (ALT)/SGPT > 3.0 X's Upper Limit of Normal (ULN); Estimated Glomerular Filtration Rate (eGFR) < 60 mL/min/1.73m2; Hemoglobin < 10 g/dL
- Seizure in the past 12 mos.
Show all 14Show fewer
- History of gastrectomy, gastric bypass, small or large bowel resection.
- History of active substance abuse.
- Current use of psychiatric medications. Current psychotic disorder and/or suicidality.
- Other chronic medical conditions or medications likely to affect appetite or food intake.
- Any investigational drug use within 30 days prior to enrollment.
- Pregnant or lactating females.
- Inability to take intranasal medication (e.g., recent injury)
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
About this study
Official title: Effect of a Single Dose of Intranasal Oxytocin on Food Intake in Obese Adolescents
The purpose of the study is to determine the effect of intranasal OXT caloric intake and eating behaviors in otherwise healthy obese adolescents.
The primary objective of this study is to determine the effects of intranasal administration of oxytocin on food intake in obese, pubertal or post-pubertal adolescents (13 to <18 years in girls, and 15 to <20 years in boys).
Read the detailed description
Participants will undergo a telephone screening and then, within 4 weeks, complete an in-person screening visit to determine eligibility. Then, within 4 weeks they will be randomized to either OXT or placebo. After a minimum 1-week (7-28 days) "washout," participants will cross-over to treatment with the other condition (i.e., placebo or OXT).
- Conditions
- Obesity
- Being tested
- Syntocinon, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SyntocinonDrug
Also called Intranasal Oxytocin
The active substance of Syntocinon is a synthetic nonapeptide identical to the posterior pituitary hormone oxytocin.
PlaceboDrug
Also called Placebo (for Syntocinon)
The placebo is identical to the Syntocinon formulation with the exception of the active compound, i.e., without oxytocin.
| Study group | Role | What they receive |
|---|---|---|
| Syntocinon (=Oxytocin), then Placebo | Experimental | 1. Single-Dose Intranasal Oxytocin
2. Single-Dose Placebo Receives: Drug: Syntocinon; Drug: Placebo |
| Placebo, then Syntocinon (=Oxytocin) | Experimental | 1. Single-Dose Placebo
2. Single-Dose Intranasal Oxytocin Receives: Drug: Syntocinon; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on Food Intake
Kilocalories Consumed at as desired ('Ad Lib') Test Meal
Measured: 28 Days
Secondary outcomes (3)
Adverse Events
Number of participants with adverse events.
Measured: 28 Days
Effect of OXT on Eating Behaviors at Mealtime (appetite)
Investigators will assess appetite, a visual analog scale (VAS) to quantify participants' self-reported appetite on a linear scale will be used. The range of the VAS is 0% to 100% of the scale, with 0% corresponding to no self-reported appetite, and 100% corresponding to maximal self-reported appetite.
Measured: 28 Days
Effect of OXT on Eating Behaviors at Mealtime (impulsivity)
Investigators will measure impulsivity, which may affect the decision to eat, performance on a computerized stop-signal task will be assessed. Outcome measures include: direction errors (#, more = more errors), proportion of successful stops (%, higher = more successful), reaction time on "Go" trials (longer = slower), stop signal reaction time (longer= slower).
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study startSep 2018 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: Grant proposal not funded, study has been withdrawn with IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shana McCormack, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shana McCormack, MD, Children's Hospital of Philadelphia
- Investigators
- Shana E McCormack, MD, MTR, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497988
- Sponsor's protocol ID
- 17-014360
- Status last verified
- Dec 2018
- First submitted
- 19 Mar 2018
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Single Dose of Intranasal Oxytocin on Food Intake in Obese Adolescents
- ClinicalTrials.gov ID
- NCT03497988
- Acronym / sponsor ID
- 17-014360
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Grant proposal not funded, study has been withdrawn with IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shana McCormack, MDUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 13 Apr 2018 (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.
The purpose of the study is to determine the effect of intranasal OXT caloric intake and eating behaviors in otherwise healthy obese adolescents.
The primary objective of this study is to determine the effects of intranasal administration of oxytocin on food intake in obese, pubertal or post-pubertal adolescents (13 to <18 years in girls, and 15 to <20 years in boys).
Detailed description
Participants will undergo a telephone screening and then, within 4 weeks, complete an in-person screening visit to determine eligibility. Then, within 4 weeks they will be randomized to either OXT or placebo. After a minimum 1-week (7-28 days) "washout," participants will cross-over to treatment with the other condition (i.e., placebo or OXT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Syntocinon (=Oxytocin), then Placebo | Experimental | Drug: Syntocinon, Drug: Placebo1. Single-Dose Intranasal Oxytocin 2. Single-Dose Placebo |
| Placebo, then Syntocinon (=Oxytocin) | Experimental | Drug: Syntocinon, Drug: Placebo1. Single-Dose Placebo 2. Single-Dose Intranasal Oxytocin |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Proficient in English.
- Pubertal or Post-Pubertal Females: 13 to <18 years.
- Pubertal or Post-Pubertal Males: 15 to <20 years.
- Girls must have a negative urine pregnancy test and post-menarchal girls must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.
- Currently obese (BMI >95%ile for age/sex if age < 18 years, BMI > 30 kg/m2 age 18 - 20 years). In children, obesity is defined with respect to age- and sex based as greater than or equal to the 95th%ile1, whereas in adults, an absolute threshold is used.
Key exclusion criteria (14 listed)
- Diabetes mellitus requiring insulin or insulin secretagogue. (Laboratory values: HgbA1c ≥8.5%)
- Cardiovascular condition, as defined as any of the following: i) abnormal blood pressure, defined as <3%ile or >97%ile for age, sex and height 3, for adult participants abnormal blood pressure is defined as Stage 2 hypertension (systolic BP > 160 mm Hg or diastolic BP > 100 mm Hg); ii) history of cardiac arrhythmia or arrhythmia detected on screening ECG; iii) history of heart failure and/or cardiomyopathy; iv) prolonged QTc interval (QTc > 460 msec), and/or long QT syndrome phenotype and/or positive genotype for long QT syndrome pathogenic mutations.
- Concurrent use of medications known to prolong QTc interval and pose high risk for Torsades de Pointes (TdP) according to the current information available (www.crediblemeds.org). Concomitant medications will be assessed by the Investigational Drug Service (IDS) pharmacist, in collaboration with the study cardiologist, if additional clarification is needed. In addition, we require that potential participants be on a stable dose for at least 2 months of any medication with the potential to alter cardiac rhythm to ensure the screening ECG reflects steady-state physiology.
- Laboratory abnormalities that indicate abnormal sodium level, liver or renal disease, or anemia:
- Sodium - Outside Normal Range; Aspartate Aminotransferase (AST)/SGOT > 3.0 X's Upper Limit of Normal (ULN); Alanine Aminotransferase (ALT)/SGPT > 3.0 X's Upper Limit of Normal (ULN); Estimated Glomerular Filtration Rate (eGFR) < 60 mL/min/1.73m2; Hemoglobin < 10 g/dL
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 |
|---|---|---|
| SyntocinonAlso: Intranasal OxytocinThe active substance of Syntocinon is a synthetic nonapeptide identical to the posterior pituitary hormone oxytocin. | Drug | Placebo, then Syntocinon (=Oxytocin), Syntocinon (=Oxytocin), then Placebo |
| PlaceboAlso: Placebo (for Syntocinon)The placebo is identical to the Syntocinon formulation with the exception of the active compound, i.e., without oxytocin. | Drug | Placebo, then Syntocinon (=Oxytocin), Syntocinon (=Oxytocin), then Placebo |
Primary outcome
Effect on Food Intake
Time frame: 28 Days
Kilocalories Consumed at as desired ('Ad Lib') Test Meal
3 secondary outcomes
Adverse Events
Time frame: 28 Days
Effect of OXT on Eating Behaviors at Mealtime (appetite)
Time frame: 28 Days
Effect of OXT on Eating Behaviors at Mealtime (impulsivity)
Time frame: 28 Days
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 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Shana E McCormack, MD, MTR principal investigator
Children's Hospital of Philadelphia
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Syntocinon in people with Obesity, run by Shana McCormack, MD.
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 6 inclusion and 14 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 Dec 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effect on Food Intake (time frame: 28 Days). 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 Dec 2018.