ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 9 for:    oxytocin | Recruiting, Not yet recruiting Studies | Texas, United States

The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity (INOSO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03119610
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : July 10, 2018
Sponsor:
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
Information provided by (Responsible Party):
Sara Espinoza, The University of Texas Health Science Center at San Antonio

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Sarcopenic Obesity Sarcopenia Aging Sedentary Lifestyle Drug: Oxytocin nasal spray Drug: Placebo nasal spray Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity
Actual Study Start Date : September 22, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Oxytocin nasal spray
Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered
Drug: Oxytocin nasal spray
Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)
Other Names:
  • Intranasal oxytocin
  • Syntocinon nasal spray

Experimental: Placebo nasal spray
Placebo nasal spray, 4x a day for 8 weeks, self administered
Drug: Placebo nasal spray
Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)
Other Name: Saline nasal spray




Primary Outcome Measures :
  1. Change in body weight [ Time Frame: 8 weeks ]
    Intranasal oxytocin will promote weight loss and preserve muscle mass


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Change in walking speed [ Time Frame: 8 weeks ]
    Pre- and post-measurements will be examined for individual change with intranasal oxytocin

  5. 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

  6. 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

  7. 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

  8. 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

  9. Change in inflammatory marker (adiponectin) in plasma [ Time Frame: 8 weeks ]
    Pre- and post-measurements will be examined for individual change with intranasal oxytocin

  10. 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

  11. 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

  12. 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

  13. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119610


Contacts
Contact: Sara E Espinoza, MD 210-617-5197 espinozas2@uthscsa.edu
Contact: Nicolas Musi, MD 210-617-5197 musi@uthscsa.edu

Locations
United States, Texas
Texas Diabetic Institute Recruiting
San Antonio, Texas, United States, 78207
Contact: Sara E Espinoza, MD    210-617-5197    espinozas2@uthscsa.edu   
Contact: Nicolas Musi, MD    210-617-5197    musi@uthscsa.edu   
Sponsors and Collaborators
Sara Espinoza
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
Investigators
Principal Investigator: Sara Espinoza, MD The University of Texas Health Science Center, San Antonio

Responsible Party: Sara Espinoza, Associate Professor of Medicine, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT03119610     History of Changes
Other Study ID Numbers: HSC20160661H
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Oxytocin
Obesity
Sarcopenia
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs