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

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ClinicalTrials.gov Identifier: NCT03119610
Recruitment Status : Completed
First Posted : April 18, 2017
Results First Posted : October 22, 2020
Last Update Posted : October 22, 2020
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

Tracking Information
First Submitted Date  ICMJE March 22, 2017
First Posted Date  ICMJE April 18, 2017
Results First Submitted Date  ICMJE August 24, 2020
Results First Posted Date  ICMJE October 22, 2020
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE September 22, 2017
Actual Primary Completion Date December 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2020)
Change in Body Weight [ Time Frame: Baseline to 8 weeks ]
Intranasal oxytocin will promote weight loss and preserve muscle mass
Original Primary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
Change in Body Weight [ Time Frame: 8 weeks ]
Intranasal oxytocin will promote weight loss and preserve muscle mass
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2020)
  • Change in Fat Mass [ Time Frame: Baseline to 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 Body Mass Index [ Time Frame: 8 weeks ]
    Pre- and post-measurements of lean mass by DXA will be examined for individual change with intranasal oxytocin. Change in body mass index (BMI).
  • Change in Glucose Levels Measured Using the Glucose Tolerance Test [ 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 Short Physical Performance Battery (SPPB) [ Time Frame: Baseline to 8 weeks ]
    Pre- and post-measurements will be examined for individual change with intranasal oxytocin. This battery of tests is scored on a scale with 3 SPPB calculation components:
    1. Ability to stand for 10 seconds with feet in 3 different positions, scored from 0 min to 4 maximum, with a higher score indicating better balance.(3 Balance subsets: side by side stand scored from 0-1; semi-tandem stance scored from 0-1; tandem stance scored from 0-2)
    2. Two timed trials of a 3m or 4 m walk (fastest recorded). Scoring is from 0-4, with 0 being unable to walk and 4 indicating a faster walk time.
    3. Time to rise from a chair five times is scored from 0-4, with 0 being unable to complete the activity, and 4 indicating that time to complete is less than 11.1 seconds.
    Total Score is the sum of all 3 scores: Minimum = 0 Maximum = 12. Higher scores indicate better lower extremity function. Difference between baseline and 8 week performance is reported.
  • Change in HbA1c (Hemoglobin A1c) [ Time Frame: Baseline to 8 weeks ]
    Pre- and post-measurements will be examined for individual change with intranasal oxytocin
  • Change in Waist Circumference [ Time Frame: Baseline to 8 weeks ]
    Pre- and post-measurements will be examined for individual change with intranasal oxytocin
  • Change in Total Cholesterol [ Time Frame: Baseline to 8 weeks ]
    Pre- and post-measurements will be examined for individual change with intranasal oxytocin
  • Change in Low Density Lipoproteins (LDL) [ Time Frame: Baseline to 8 weeks ]
    Pre- and post-measurements will be examined for individual change with intranasal oxytocin
  • Change in High Density Lipoproteins (HDL) [ Time Frame: Baseline to 8 weeks ]
    Pre- and post-measurements will be examined for individual change with intranasal oxytocin
  • Change in Triglycerides [ Time Frame: Baseline to 8 weeks ]
    Pre- and post-measurements will be examined for individual change with intranasal oxytocin
  • Change in Center for Epidemiologic Studies Scale (CES-D) [ Time Frame: Baseline to 8 weeks ]
    Pre- and post-measurements will be examined for individual change with intranasal oxytocin. This is measured on a 20 item scale using the following scoring using number of week days:
    1. Rarely or none of the time ( less than 1 day)
    2. Some or a little of the time (1-2 days)
    3. Occasionally or a moderate amount of time (3-4 days)
    4. Most or all of the time (5-7 days) SCORING: zero for answers =1), 1 for answers =2), 2 for answers =3) column, 3 for answers =4) The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
  • Change in Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline to 8 weeks ]
    Pre- and post-measurements will be examined for individual change with intranasal oxytocin. A 30-point test, with a score of 0 or 1 assigned to each item. The minimum score is 0 and the maximum is 30. The higher the score, the less cognitive impairment.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity
Official Title  ICMJE The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Obesity
  • Sarcopenic Obesity
  • Sarcopenia
  • Aging
  • Sedentary Lifestyle
Intervention  ICMJE
  • 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
  • Drug: Placebo nasal spray
    Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)
    Other Name: Saline nasal spray
Study Arms  ICMJE
  • Experimental: Oxytocin nasal spray
    Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered
    Intervention: Drug: Oxytocin nasal spray
  • Experimental: Placebo nasal spray
    Placebo nasal spray, 4x a day for 8 weeks, self administered
    Intervention: Drug: Placebo nasal spray
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 24, 2020)
23
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2017)
36
Actual Study Completion Date  ICMJE December 17, 2019
Actual Primary Completion Date December 17, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03119610
Other Study ID Numbers  ICMJE HSC20160661H
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sara Espinoza, The University of Texas Health Science Center at San Antonio
Study Sponsor  ICMJE Sara Espinoza
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Sara Espinoza, MD The University of Texas Health Science Center, San Antonio
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP