RECRUITING

Oxytocin for Weight Loss in Adolescents

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in youths with obesity, ages 12-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (1 spray per nostril, 4 times per day) for 12 weeks. Study visits include screening to determine eligibility, 2-part main study visits at baseline, week 8, and week 12, and safety check-in visits at weeks 1, and 4; phone calls at weeks 2, 6, and 10, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include appetite, behavioral, metabolic, and endocrine assessments.

Official Title

Oxytocin as a Neuroendocrine Therapy for Obesity in Youth

Quick Facts

Study Start:2021-07-28
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04551482

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males and Females, 12-18 years
  2. * Obesity (BMI ≥95th percentile for age and gender)
  3. * Willingness to maintain current diet and lifestyle for the duration of study participation
  1. * Active substance abuse
  2. * Use of prescription or over-the-counter drugs or dietary/herbal supplements for the purpose of weight loss. Medications/supplements that may affect weight will be allowed if participants are on a stable dose with stable weight for at least 3 months.
  3. * Greater than 5kg weight loss over 3 months;
  4. * Follows a nonstandard diet (e.g., gluten-free, vegan, Paleo, Atkins, raw diet, macrobiotic diet)
  5. * Cardiovascular disease
  6. * Prolonged QT interval
  7. * Chronic gastrointestinal disorders and other inflammatory conditions
  8. * Epilepsy
  9. * Untreated thyroid disease
  10. * Alanine transaminase (ALT) or aspartate transaminase (AST) \>2.5 times upper limit of normal
  11. * Creatinine \>1.5 mg/dl
  12. * Hyponatremia
  13. * Pregnancy/breastfeeding or refusal to use contraception not containing estrogen throughout the study if female and sexually active
  14. * MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clips
  15. * Weight \>450 lbs due to limits for MRI and DXA scanners
  16. * Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus if HbA1c \>8%
  17. * Active eating disorder

Contacts and Locations

Study Contact

Elizabeth A Lawson, MD, MMSc
CONTACT
617-726-3870
ealawson@partners.org

Principal Investigator

Elizabeth Lawson, MD, MMSc
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Elizabeth Lawson, MD, MMSc, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-28
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2021-07-28
Study Completion Date2027-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity, Adolescent
  • Oxytocin