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

Primary Purpose

Obesity, Sarcopenic Obesity, Sarcopenia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxytocin nasal spray
Placebo nasal spray
Sponsored by
Sara Espinoza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

60 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Texas Diabetic Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Oxytocin nasal spray

Placebo nasal spray

Arm Description

Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered

Placebo nasal spray, 4x a day for 8 weeks, self administered

Outcomes

Primary Outcome Measures

Change in Body Weight
Intranasal oxytocin will promote weight loss and preserve muscle mass

Secondary Outcome Measures

Change in Fat Mass
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
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
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)
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: 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) 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. 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)
Pre- and post-measurements will be examined for individual change with intranasal oxytocin
Change in Waist Circumference
Pre- and post-measurements will be examined for individual change with intranasal oxytocin
Change in Total Cholesterol
Pre- and post-measurements will be examined for individual change with intranasal oxytocin
Change in Low Density Lipoproteins (LDL)
Pre- and post-measurements will be examined for individual change with intranasal oxytocin
Change in High Density Lipoproteins (HDL)
Pre- and post-measurements will be examined for individual change with intranasal oxytocin
Change in Triglycerides
Pre- and post-measurements will be examined for individual change with intranasal oxytocin
Change in Center for Epidemiologic Studies Scale (CES-D)
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: Rarely or none of the time ( less than 1 day) Some or a little of the time (1-2 days) Occasionally or a moderate amount of time (3-4 days) 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)
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.

Full Information

First Posted
March 22, 2017
Last Updated
October 1, 2021
Sponsor
Sara Espinoza
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
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1. Study Identification

Unique Protocol Identification Number
NCT03119610
Brief Title
The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity
Acronym
INOSO
Official Title
The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 22, 2017 (Actual)
Primary Completion Date
December 17, 2018 (Actual)
Study Completion Date
December 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sara Espinoza
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Sarcopenic Obesity, Sarcopenia, Aging, Sedentary Lifestyle

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin nasal spray
Arm Type
Experimental
Arm Description
Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered
Arm Title
Placebo nasal spray
Arm Type
Experimental
Arm Description
Placebo nasal spray, 4x a day for 8 weeks, self administered
Intervention Type
Drug
Intervention Name(s)
Oxytocin nasal spray
Other Intervention Name(s)
Intranasal oxytocin, Syntocinon nasal spray
Intervention Description
Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)
Intervention Type
Drug
Intervention Name(s)
Placebo nasal spray
Other Intervention Name(s)
Saline nasal spray
Intervention Description
Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)
Primary Outcome Measure Information:
Title
Change in Body Weight
Description
Intranasal oxytocin will promote weight loss and preserve muscle mass
Time Frame
Baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Change in Fat Mass
Description
Pre- and post-measurements of fat mass by dual energy x-ray absorptiometry (DXA) will be examined for individual change with intranasal oxytocin
Time Frame
Baseline to 8 weeks
Title
Change in Body Mass Index
Description
Pre- and post-measurements of lean mass by DXA will be examined for individual change with intranasal oxytocin. Change in body mass index (BMI).
Time Frame
8 weeks
Title
Change in Glucose Levels Measured Using the Glucose Tolerance Test
Description
Pre- and post-measurements of oral glucose tolerance test for 2-hour plasma glucose will be examined for individual change with intranasal oxytocin
Time Frame
8 weeks
Title
Change in Short Physical Performance Battery (SPPB)
Description
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: 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) 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. 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.
Time Frame
Baseline to 8 weeks
Title
Change in HbA1c (Hemoglobin A1c)
Description
Pre- and post-measurements will be examined for individual change with intranasal oxytocin
Time Frame
Baseline to 8 weeks
Title
Change in Waist Circumference
Description
Pre- and post-measurements will be examined for individual change with intranasal oxytocin
Time Frame
Baseline to 8 weeks
Title
Change in Total Cholesterol
Description
Pre- and post-measurements will be examined for individual change with intranasal oxytocin
Time Frame
Baseline to 8 weeks
Title
Change in Low Density Lipoproteins (LDL)
Description
Pre- and post-measurements will be examined for individual change with intranasal oxytocin
Time Frame
Baseline to 8 weeks
Title
Change in High Density Lipoproteins (HDL)
Description
Pre- and post-measurements will be examined for individual change with intranasal oxytocin
Time Frame
Baseline to 8 weeks
Title
Change in Triglycerides
Description
Pre- and post-measurements will be examined for individual change with intranasal oxytocin
Time Frame
Baseline to 8 weeks
Title
Change in Center for Epidemiologic Studies Scale (CES-D)
Description
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: Rarely or none of the time ( less than 1 day) Some or a little of the time (1-2 days) Occasionally or a moderate amount of time (3-4 days) 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.
Time Frame
Baseline to 8 weeks
Title
Change in Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
Baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Espinoza, MD
Organizational Affiliation
The University of Texas Health Science Center, San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Diabetic Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34029521
Citation
Espinoza SE, Lee JL, Wang CP, Ganapathy V, MacCarthy D, Pascucci C, Musi N, Volpi E. Intranasal Oxytocin Improves Lean Muscle Mass and Lowers LDL Cholesterol in Older Adults with Sarcopenic Obesity: A Pilot Randomized Controlled Trial. J Am Med Dir Assoc. 2021 Sep;22(9):1877-1882.e2. doi: 10.1016/j.jamda.2021.04.015. Epub 2021 May 21.
Results Reference
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The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity

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