Clinical Trials Logo
NCT number NCT03119610
Study type Interventional
Source The University of Texas Health Science Center at San Antonio
Contact Sara E Espinoza, MD
Phone 210-617-5197
Status Recruiting
Phase Phase 1/Phase 2
Start date September 22, 2017
Completion date May 2018

Clinical Trial Summary

Obesity is highly prevalent in older adults and is a major cause of sarcopenia and disability in older adults. Although exercise can counteract the effects of obesity and sarcopenia, many have difficulty adhering to an exercise program and the benefits of exercise are variable. Therefore, there is an urgent need to test novel pharmacologic interventions to prevent disability and loss of independence. Oxytocin is a pituitary hormone released during parturition and lactation that is also known to suppress appetite in rodents and humans; and, recent small studies have found that intranasal oxytocin reduces body weight in adults. We propose a pilot study of intranasal oxytocin as a novel approach to promote weight loss and increase muscle mass in older subjects with sarcopenic obesity.

Clinical Trial Description

The pilot study will be conducted at 3 sites in 9 visits over a period of 12+ weeks. Older sedentary subjects will be screened for sarcopenic obesity using a modified consensus definition and evaluated at baseline for safety labs, glucose tolerance, body composition, cognition and physical performance, as well as systemic inflammatory markers in blood and muscle tissue.

Eligible subjects self-administer 24 IU intranasal oxytocin four times a day for 8 weeks.

The study will examine whether the intervention will promote weight loss and preserve muscle mass, thereby preserving and/or improving physical function in older subjects with sarcopenic obesity.

Generalized linear mixed effects model will be used to evaluate the effect of oxytocin on the change of each continuous measure. The effect of oxytocin will be assessed by whether the time by oxytocin interaction is significantly different from 0 with a 2-sided p-value<0.05.

Study Design

Related Conditions & MeSH terms

See also
  Status Clinical Trial Phase
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Recruiting NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT03299881 - Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss N/A
Enrolling by invitation NCT03063606 - Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Specialist Treatment Phase 2/Phase 3
Completed NCT02235961 - Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects Phase 1
Completed NCT03195712 - Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers N/A
Recruiting NCT00341406 - Fat Cell Size in Insulin Resistance N/A
Recruiting NCT02918279 - Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity Phase 3
Completed NCT00494767 - Investigation Of Weight Loss And Body Composition Changes After Dosing With Either Placebo Or One Of Two Active Drugs Phase 1
Recruiting NCT03277040 - Diet Eating, and Lifestyle Improvement for Valued Employees and Their Relatives N/A
Completed NCT01222793 - Effects of Antipsychotics on Eating and Food Craving in People With Schizophrenia N/A
Completed NCT00976105 - Effects of Repeat Dosing of GSK1521498 Phase 1
Completed NCT00535600 - Effects of Bariatric Surgery on Insulin N/A
Not yet recruiting NCT03104205 - MOWI Home-Based Pilot N/A
Recruiting NCT03104192 - MOWI Research Pilot N/A
Recruiting NCT03130244 - Endoscopic Procedure for Jejunal to Ileal Diversion to Treat Type 2 Diabetes N/A
Recruiting NCT03255005 - Endomina Controlled Study N/A
Not yet recruiting NCT03238794 - Bariatric Surgery Versus Diet Alone in the Bile Acid Pathway and Weight Loss N/A
Not yet recruiting NCT02924636 - Electronic-personalized Program for Obesity in Pregnancy to Improve Delivery N/A
Not yet recruiting NCT03036800 - Saxenda in Obesity Services (STRIVE Study) Phase 4