Obesity, Adolescent Clinical Trial
Official title:
Oxytocin as a Neuroendocrine Therapy for Obesity in Youth
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03358524 -
Effects of Vitamin E Supplementation on Free Radicals and Fat Level of Obese Adolescence in Jakarta, Indonesia
|
Phase 4 | |
Active, not recruiting |
NCT04213014 -
Guys/Girls Opt for Activities for Life Trial (GOAL) to Increase Young Adolescents' Physical Activity and Healthy Eating
|
N/A | |
Active, not recruiting |
NCT06089876 -
The Use of Mobile Applications in Obese and Overweight Adolescents for Health Improvement
|
N/A | |
Recruiting |
NCT05030636 -
Novel Role of Exercise Timing in Obesity
|
N/A | |
Completed |
NCT02952170 -
Impact of Weight Loss Surgery in Adolescents With NAFLD
|
N/A | |
Recruiting |
NCT03963557 -
Cognitive Function and Body Mass Index in Children and Adolescents
|
||
Completed |
NCT04044833 -
Evaluation of the Effects of Planned Trainings Given to Obese Adolescent Girls on Healthy Lifestyle Behaviors and Menstrual Symptoms
|
||
Completed |
NCT05095883 -
Correlation Between Body Weight and Foot Progression Angle in Adolescents
|
||
Withdrawn |
NCT05834062 -
Phentermine/Topiramate as Preventive Pharmacotherapy for Obesity
|
Phase 2 | |
Completed |
NCT06152068 -
Insulin Resistance, Lipid Profile, CRP, IL-18 and Carotid Intima-Media Thickness (CIMT) Diameter in Obese Adolescents
|
||
Enrolling by invitation |
NCT04094324 -
Mental Health in Children and Youth Within Pediatric Care
|
||
Not yet recruiting |
NCT05984043 -
Piloting a Biofeedback Intervention for Adolescents With Overweight and a History of Adverse Childhood Experiences
|
N/A | |
Not yet recruiting |
NCT02973867 -
Myokines Role During Obesity
|
N/A | |
Active, not recruiting |
NCT04252677 -
Health Literacy and Obesogenic Behaviors
|
N/A | |
Active, not recruiting |
NCT04719052 -
Mediterranean Enriched Diet for Tackling Youth Obesity
|
N/A | |
Completed |
NCT05966870 -
Unsweetened Sparkling Water and Changes in Sweetness Perception in Adolescents
|
N/A | |
Recruiting |
NCT05393570 -
Lifestyle Improvement for Teens With Bariatric Surgery
|
N/A | |
Enrolling by invitation |
NCT05778266 -
Effect of L-citrulline and HIIT on Arterial Stiffness and MAFLD in Adolescents
|
N/A | |
Completed |
NCT06377137 -
High-intensity Small-sided Soccer Games for Cardiometabolic Health in Adolescents With Metabolic Dysfunction
|
N/A | |
Completed |
NCT04780828 -
Investigation of the Effects of Different Levels of Obesity on the Respiratory System
|