The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity

• Status: Completed
• Trial end date: 2019-12-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sara Espinoza
• Collaborators: The University of Texas Health Science Center at San Antonio; The University of Texas Health Science Center, Houston; The University of Texas Medical Branch, Galveston
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

• BMI 30-40 kg/m2

• Sedentary (< 2 strenuous exercise/week)

• Gait speed < 1 meter/second

Exclusion Criteria:

• Diabetes (ADA criteria)

• Heart disease (MI or New York Heart Classification grade III-IV)

• Poorly controlled hypertension (SBP > 170 or DBP >95 mm/Hg)

• Anemia (Hematocrit <34%)

• Renal Disease (Serum Creatinine >1.4, abnormal serum sodium levels, abnormal urinalysis, or physical exam findings indicative of fluid imbalance; individuals with underlying disorder of sodium/water balance, such as SIADH, diabetes insipidus, or psychogenic polydipsia)

• Liver Disease (AST/ALT/AlkPhos > 2x upper limit of normal)

• Use of systemic steroid, androgens, or anti-coagulants

• Active/unstable conditions: inflammatory, thyroid, autoimmune, gastrointestinal (GI), hematologic, or neoplastic disorders

• Individuals with underlying seizure disorder or underlying neurologic disorder that increases seizure risk

• Cognitive impairment (MiniCog <3), unstable mental illness, substance abuse, or history of eating disorder