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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. Read our disclaimer for details.
 
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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 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
Actual Primary Completion Date : December 17, 2018
Actual Study Completion Date : December 17, 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: Baseline to 8 weeks ]
    Intranasal oxytocin will promote weight loss and preserve muscle mass


Secondary Outcome Measures :
  1. 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

  2. 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).

  3. 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

  4. 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.


  5. Change in HbA1c (Hemoglobin A1c) [ Time Frame: Baseline to 8 weeks ]
    Pre- and post-measurements will be examined for individual change with intranasal oxytocin

  6. Change in Waist Circumference [ Time Frame: Baseline to 8 weeks ]
    Pre- and post-measurements will be examined for individual change with intranasal oxytocin

  7. Change in Total Cholesterol [ Time Frame: Baseline to 8 weeks ]
    Pre- and post-measurements will be examined for individual change with intranasal oxytocin

  8. 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

  9. 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

  10. Change in Triglycerides [ Time Frame: Baseline to 8 weeks ]
    Pre- and post-measurements will be examined for individual change with intranasal oxytocin

  11. 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.

  12. 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.



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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


Locations
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United States, Texas
Texas Diabetic Institute
San Antonio, Texas, United States, 78207
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
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Principal Investigator: Sara Espinoza, MD The University of Texas Health Science Center, San Antonio
  Study Documents (Full-Text)

Documents provided by Sara Espinoza, The University of Texas Health Science Center at San Antonio:
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Responsible Party: Sara Espinoza, Associate Professor of Medicine, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT03119610    
Other Study ID Numbers: HSC20160661H
First Posted: April 18, 2017    Key Record Dates
Results First Posted: October 22, 2020
Last Update Posted: October 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcopenia
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs