Oxytocin for Weight Loss in Adolescents
Primary Purpose
Obesity, Adolescent, Oxytocin
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oxytocin nasal spray
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Adolescent
Eligibility 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 affecting metabolism, blood glucose, or appetite. Metformin will be allowed if participants are on a stable dose with stable weight for at least 3 months
- Greater than 5kg weight change 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
- Use of oral contraceptive pills
- 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 and type 2 Diabetes Mellitus if HbA1c >8%
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Oxytocin
Placebo
Arm Description
Oxytocin nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)
Placebo nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)
Outcomes
Primary Outcome Measures
Weight
Mean difference in weight between Oxytocin and Placebo group after 12 weeks of treatment
Height
Measure height on a stadiometer to the nearest 0.1 cm
Body mass index (BMI)
Mean difference in BMI between Oxytocin and Placebo group after 12 weeks of treatment. BMI will be calculated as weight/height2
Secondary Outcome Measures
Lean mass and Fat mass
Dual Energy Absorptiometry (DXA) will be used for measuring fat mass (kg) and lean mass (Kg)
Fasting Resting Energy Expenditure (kCal)
Assessed by Indirect calorimetry
Full Information
NCT ID
NCT04551482
First Posted
August 31, 2020
Last Updated
November 30, 2022
Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT04551482
Brief Title
Oxytocin for Weight Loss in Adolescents
Official Title
Oxytocin as a Neuroendocrine Therapy for Obesity in Youth
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
December 23, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Adolescent, Oxytocin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oxytocin
Arm Type
Experimental
Arm Description
Oxytocin nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)
Intervention Type
Drug
Intervention Name(s)
Oxytocin nasal spray
Other Intervention Name(s)
Syntocin
Intervention Description
24 IU nasal spray, 4 times per day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
24 IU nasal spray, 4 times per day for 12 weeks
Primary Outcome Measure Information:
Title
Weight
Description
Mean difference in weight between Oxytocin and Placebo group after 12 weeks of treatment
Time Frame
12 weeks
Title
Height
Description
Measure height on a stadiometer to the nearest 0.1 cm
Time Frame
Baseline
Title
Body mass index (BMI)
Description
Mean difference in BMI between Oxytocin and Placebo group after 12 weeks of treatment. BMI will be calculated as weight/height2
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Lean mass and Fat mass
Description
Dual Energy Absorptiometry (DXA) will be used for measuring fat mass (kg) and lean mass (Kg)
Time Frame
12 weeks
Title
Fasting Resting Energy Expenditure (kCal)
Description
Assessed by Indirect calorimetry
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 affecting metabolism, blood glucose, or appetite. Metformin will be allowed if participants are on a stable dose with stable weight for at least 3 months
Greater than 5kg weight change 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
Use of oral contraceptive pills
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 and type 2 Diabetes Mellitus if HbA1c >8%
Active eating disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth A Lawson, MD, MMSc
Phone
617-726-3870
Email
ealawson@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhusmita Misra, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Lawson, MD
Email
ealawson@partners.org
12. IPD Sharing Statement
Learn more about this trial
Oxytocin for Weight Loss in Adolescents
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