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Oxytocin for Weight Loss in Adolescents

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ClinicalTrials.gov Identifier: NCT04551482
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : May 16, 2024
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Elizabeth Austen Lawson, Massachusetts General Hospital

Study Description
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Brief Summary:
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 (3 sprays 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.

Condition or disease Intervention/treatment Phase
Obesity, Adolescent Oxytocin Drug: Oxytocin nasal spray Drug: Placebo Phase 2

Detailed Description:

In recent years there has been a dramatic increase in obesity and its complications in both children and adults. Earlier treatment substantially reduces the likelihood of developing complications later in life while concurrently improving quality of life and decreasing mortality. Therefore, it is essential to develop safe and effective therapeutic strategies for weight loss, particularly in adolescents. Oxytocin (OXT), a hypothalamic peptide hormone that regulates energy balance, is a novel neuroendocrine weight-loss therapeutic in adults with obesity because it simultaneously reduces energy intake and increases energy expenditure and is well-tolerated. Data are currently lacking regarding effects of OXT administration in adolescents with obesity.

The current study is a 12-week randomized controlled trial (RCT) of OXT vs. placebo in 12-18-year old adolescents with obesity. We hypothesize that OXT administration will decrease weight as a consequence of decreased caloric intake and increased energy expenditure, both partially mediated by reduced hypothalamic inflammation (such inflammation drives weight gain by increasing food intake and reducing energy expenditure). Further, OXT will improve metabolic risk markers, such as visceral and intrahepatic fat, systemic inflammation, and serum lipids.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Oxytocin as a Neuroendocrine Therapy for Obesity in Youth
Actual Study Start Date : July 28, 2021
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : March 31, 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Oxytocin
Oxytocin nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)
 Drug: Oxytocin nasal spray
24 IU nasal spray, 4 times per day for 12 weeks
Other Name: Syntocin
Placebo Comparator: Placebo
Placebo nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)
 Drug: Placebo
24 IU nasal spray, 4 times per day for 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Weight [ Time Frame: 12 weeks ]
    Mean difference in weight between Oxytocin and Placebo group after 12 weeks of treatment

  2. Height [ Time Frame: Baseline ]
    Measure height on a stadiometer to the nearest 0.1 cm

  3. Body mass index (BMI) [ Time Frame: 12 weeks ]
    Mean difference in BMI between Oxytocin and Placebo group after 12 weeks of treatment. BMI will be calculated as weight/height2


Secondary Outcome Measures :
  1. Lean mass and Fat mass [ Time Frame: 12 weeks ]
    Dual Energy Absorptiometry (DXA) will be used for measuring fat mass (kg) and lean mass (Kg)

  2. Fasting Resting Energy Expenditure (kCal) [ Time Frame: 12 weeks ]
    Assessed by Indirect calorimetry


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and Females, 12-18 years
  • Obesity (BMI ≥95th percentile for age and gender)
  • Willingness to maintain current diet and lifestyle for the duration of study participation

Exclusion Criteria:

  • Active substance abuse
  • 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.
  • Greater than 5kg weight loss over 3 months;
  • Follows a nonstandard diet (e.g., gluten-free, vegan, Paleo, Atkins, raw diet, macrobiotic diet)
  • Cardiovascular disease
  • Prolonged QT interval
  • Chronic gastrointestinal disorders and other inflammatory conditions
  • Epilepsy
  • Untreated thyroid disease
  • Alanine transaminase (ALT) or aspartate transaminase (AST) >2.5 times upper limit of normal
  • Creatinine >1.5 mg/dl
  • Hyponatremia
  • Pregnancy/breastfeeding or refusal to use contraception not containing estrogen throughout the study if female and sexually active
  • MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clips
  • Weight >450 lbs due to limits for MRI and DXA scanners
  • Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus if HbA1c >8%
  • Active eating disorder
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04551482


Contacts
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Contact: Elizabeth A Lawson, MD, MMSc 617-726-3870 ealawson@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Elizabeth A Lawson, MD       ealawson@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Elizabeth Lawson, MD, MMSc Massachusetts General Hospital
More Information
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Responsible Party: Elizabeth Austen Lawson, Associate Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04551482    
Other Study ID Numbers: 2020P002511
1R01DK124223-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: May 16, 2024
Last Verified: May 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overweight
Overnutrition
Nutrition Disorders
 Body Weight
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs