Intranasal Oxytocin and Food Intake in Obese Adolescents

NCT03497988 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 17-014360
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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 to \<18 years in girls, and 15 to \<20 years in boys).

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Effect on Food Intake

  Kilocalories Consumed at as desired ('Ad Lib') Test Meal

  28 Days

Secondary Outcomes (3)

• Adverse Events

  28 Days

• Effect of OXT on Eating Behaviors at Mealtime (appetite)

  28 Days

• Effect of OXT on Eating Behaviors at Mealtime (impulsivity)

  28 Days

Study Arms (2)

Syntocinon (=Oxytocin), then Placebo

EXPERIMENTAL

1. Single-Dose Intranasal Oxytocin 2. Single-Dose Placebo

Drug: Syntocinon; Drug: Placebo

Placebo, then Syntocinon (=Oxytocin)

EXPERIMENTAL

1. Single-Dose Placebo 2. Single-Dose Intranasal Oxytocin

Drug: Syntocinon; Drug: Placebo

Interventions

Syntocinon DRUG

The active substance of Syntocinon is a synthetic nonapeptide identical to the posterior pituitary hormone oxytocin.

Also known as: Intranasal Oxytocin

Placebo, then Syntocinon (=Oxytocin); Syntocinon (=Oxytocin), then Placebo

Placebo DRUG

The placebo is identical to the Syntocinon formulation with the exception of the active compound, i.e., without oxytocin.

Also known as: Placebo (for Syntocinon)

Placebo, then Syntocinon (=Oxytocin); Syntocinon (=Oxytocin), then Placebo

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shana McCormack, MD: lead

MeSH Terms

Conditions

Obesity

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Shana E McCormack, MD, MTR

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician, Sponsor Investigator

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: April 13, 2018
• Study Start: September 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2021
• Last Updated: December 26, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share