The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity

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.

Conditions

• Obesity
• Sarcopenic Obesity
• Sarcopenia
• Aging
• Sedentary Lifestyle

Interventions

DRUG

Oxytocin nasal spray

Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)

DRUG

Placebo nasal spray

Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio

  collaborator OTHER

• The University of Texas Health Science Center, Houston

  collaborator OTHER

• The University of Texas Medical Branch, Galveston

  collaborator OTHER

• Sara Espinoza

  lead OTHER

Principal Investigators

• Sara Espinoza, MD · The University of Texas Health Science Center, San Antonio

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-22

Primary Completion

2018-12-17

Completion

2019-12-17

FDA Drug

Yes

Countries

• United States

Study Locations