The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 17, 2018

Detailed 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.

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)

Arms, Groups and Cohorts

  • Experimental: Oxytocin nasal spray
    • Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered
  • Experimental: Placebo nasal spray
    • Placebo nasal spray, 4x a day for 8 weeks, self administered

Clinical Trial Outcome Measures

Primary Measures

  • Change in body weight
    • Time Frame: 8 weeks
    • Intranasal oxytocin will promote weight loss and preserve muscle mass

Secondary Measures

  • Change in adiposity
    • Time Frame: 8 weeks
    • Pre- and post-measurements of fat mass by dual energy x-ray absorptiometry (DXA) will be examined for individual change with intranasal oxytocin
  • Change in muscle mass
    • Time Frame: 8 weeks
    • Pre- and post-measurements of lean mass by DXA will be examined for individual change with intranasal oxytocin
  • Change in glucose tolerance
    • Time Frame: 8 weeks
    • Pre- and post-measurements of oral glucose tolerance test for 2-hour plasma glucose will be examined for individual change with intranasal oxytocin
  • Change in walking speed
    • Time Frame: 8 weeks
    • Pre- and post-measurements will be examined for individual change with intranasal oxytocin
  • Change in grip strength
    • Time Frame: 8 weeks
    • Pre- and post-measurements will be examined for individual change with intranasal oxytocin by dynamometer readings (x3, averaged), dominant hand, while seated
  • Change in inflammatory marker (TNF-α) in plasma
    • Time Frame: 8 weeks
    • Pre- and post-measurements will be examined for individual change with intranasal oxytocin
  • Change in inflammatory marker (C-reactive protein) in plasma
    • Time Frame: 8 weeks
    • Pre- and post-measurements will be examined for individual change with intranasal oxytocin
  • Change in inflammatory marker (IL-6) in plasma
    • Time Frame: 8 weeks
    • Pre- and post-measurements will be examined for individual change with intranasal oxytocin
  • Change in inflammatory marker (adiponectin) in plasma
    • Time Frame: 8 weeks
    • Pre- and post-measurements will be examined for individual change with intranasal oxytocin
  • Change in inflammatory marker (IL-β) in muscle
    • Time Frame: 8 weeks
    • Pre- and post-measurements will be examined for individual change with intranasal oxytocin
  • Change in inflammatory marker (IL-6) in muscle
    • Time Frame: 8 weeks
    • Pre- and post-measurements will be examined for individual change with intranasal oxytocin
  • Change in inflammatory marker (MCP-1) in muscle
    • Time Frame: 8 weeks
    • Pre- and post-measurements will be examined for individual change with intranasal oxytocin
  • Change in inflammatory marker (TNF-α mRNA) in muscle
    • Time Frame: 8 weeks
    • Pre- and post-measurements will be examined for individual change with intranasal oxytocin

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sara Espinoza
  • Collaborator
    • The University of Texas Health Science Center at San Antonio
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Sara Espinoza, Associate Professor of Medicine – The University of Texas Health Science Center at San Antonio
  • Overall Official(s)
    • Sara Espinoza, MD, Principal Investigator, The University of Texas Health Science Center, San Antonio

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.