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| Name | Class |
|---|---|
| The University of Texas Health Science Center at San Antonio | OTHER |
| The University of Texas Health Science Center, Houston | OTHER |
| The University of Texas Medical Branch, Galveston | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin nasal spray | Experimental | Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered |
|
| Placebo nasal spray | Experimental | Placebo nasal spray, 4x a day for 8 weeks, self administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin nasal spray | Drug | Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Intranasal oxytocin will promote weight loss and preserve muscle mass | Baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to 8 weeks |
| Change in Body Mass Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Espinoza, MD | The University of Texas Health Science Center, San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Diabetic Institute | San Antonio | Texas | 78207 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34029521 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxytocin Nasal Spray | Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray) |
| FG001 | Placebo Nasal Spray | Placebo nasal spray, 4x a day for 8 weeks, self administered Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxytocin Nasal Spray | Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray) |
| BG001 | Placebo Nasal Spray |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Participants are included if age 60 or over. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Body Weight | Intranasal oxytocin will promote weight loss and preserve muscle mass | Two participants withdrew after randomization; 1 in Oxytocin and 1 in Placebo group. Data from these two subjects were not collected. | Posted | Mean | Standard Deviation | Kilograms | Baseline to 8 weeks |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxytocin Nasal Spray | Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara Espinoza, MD | UT Health San Antonio | 210-617-5197 | espinozas2@uthscsa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 3, 2018 | Nov 13, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D055948 | Sarcopenia |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo nasal spray | Drug | Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray) |
|
|
Pre- and post-measurements of lean mass by DXA will be examined for individual change with intranasal oxytocin. Change in body mass index (BMI).
| 8 weeks |
| 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 | 8 weeks |
| 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:
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. | Baseline to 8 weeks |
| Change in HbA1c (Hemoglobin A1c) | Pre- and post-measurements will be examined for individual change with intranasal oxytocin | Baseline to 8 weeks |
| Change in Waist Circumference | Pre- and post-measurements will be examined for individual change with intranasal oxytocin | Baseline to 8 weeks |
| Change in Total Cholesterol | Pre- and post-measurements will be examined for individual change with intranasal oxytocin | Baseline to 8 weeks |
| Change in Low Density Lipoproteins (LDL) | Pre- and post-measurements will be examined for individual change with intranasal oxytocin | Baseline to 8 weeks |
| Change in High Density Lipoproteins (HDL) | Pre- and post-measurements will be examined for individual change with intranasal oxytocin | Baseline to 8 weeks |
| Change in Triglycerides | Pre- and post-measurements will be examined for individual change with intranasal oxytocin | Baseline to 8 weeks |
| 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:
| Baseline to 8 weeks |
| 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. | Baseline to 8 weeks |
Placebo nasal spray, 4x a day for 8 weeks, self administered Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray) |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | Kilograms | Baseline to 8 weeks |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | kg/m2 | 8 weeks |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | mg/dL | 8 weeks |
|
|
|
| Secondary | 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:
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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 8 weeks |
|
|
|
| Secondary | Change in HbA1c (Hemoglobin A1c) | Pre- and post-measurements will be examined for individual change with intranasal oxytocin | Posted | Mean | Standard Deviation | Percentage | Baseline to 8 weeks |
|
|
|
| Secondary | Change in Waist Circumference | Pre- and post-measurements will be examined for individual change with intranasal oxytocin | Posted | Mean | Standard Deviation | centimeteres | Baseline to 8 weeks |
|
|
|
| Secondary | Change in Total Cholesterol | Pre- and post-measurements will be examined for individual change with intranasal oxytocin | Posted | Mean | Standard Deviation | mg/dL | Baseline to 8 weeks |
|
|
|
| Secondary | Change in Low Density Lipoproteins (LDL) | Pre- and post-measurements will be examined for individual change with intranasal oxytocin | Posted | Mean | Standard Deviation | mg/dL | Baseline to 8 weeks |
|
|
|
| Secondary | Change in High Density Lipoproteins (HDL) | Pre- and post-measurements will be examined for individual change with intranasal oxytocin | Posted | Mean | Standard Deviation | mg/dL | Baseline to 8 weeks |
|
|
|
| Secondary | Change in Triglycerides | Pre- and post-measurements will be examined for individual change with intranasal oxytocin | Posted | Mean | Standard Deviation | mg/dL | Baseline to 8 weeks |
|
|
|
| Secondary | 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:
| Posted | Mean | Standard Deviation | score on a scale | Baseline to 8 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 8 weeks |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 12 |
| 12 |
| EG001 | Placebo Nasal Spray | Placebo nasal spray, 4x a day for 8 weeks, self administered Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray) | 0 | 9 | 0 | 9 | 9 | 9 |
| Headache | Nervous system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Nasal Irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sinus Disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Postnasal Drip | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Tiredness | General disorders | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Flu like symptoms | General disorders | Systematic Assessment |
|
| Lightheaded | Nervous system disorders | Systematic Assessment |
|
| Sore Throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Skin Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Confusion | Nervous system disorders | Systematic Assessment |
|
| Delirium | Nervous system disorders | Systematic Assessment |
|
| Irritability | General disorders | Systematic Assessment |
|
| Bruise related to biopsy | Vascular disorders | Systematic Assessment |
|
| Upset stomach | Gastrointestinal disorders | Systematic Assessment |
|
| Muscle Aches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle spasms, hands | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle spasms, legs | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Leg cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | Systematic Assessment |
|
| Decreased Appetite | Gastrointestinal disorders | Systematic Assessment |
|
| Migraine | Nervous system disorders | Systematic Assessment |
|
| Throat itching | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Loose stool | Gastrointestinal disorders | Systematic Assessment |
|
| Increased bowel movement | Gastrointestinal disorders | Systematic Assessment |
|
| Bladder disturbance | Renal and urinary disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D001519 | Behavior |