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Completed

NCT Number: NCT03119610

The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity

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.

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Key information

Conditions

Obesity Aging Atrophy Behavior Body Weight Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Sarcopenic Obesity Sedentary Behavior Sedentary Lifestyle Signs and Symptoms

Age range

60 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Texas Diabetic Institute

San Antonio, Texas, 78207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin nasal spray

Drug

Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)

Other names: Intranasal oxytocin, Syntocinon nasal spray

Placebo nasal spray

Drug

Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)

Other names: Saline nasal spray

Primary outcomes

  1. Change in Body Weight

    Time frame: Baseline to 8 weeks

    Intranasal oxytocin will promote weight loss and preserve muscle mass

Secondary outcomes

  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:

    • 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.

  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:

    • 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.

  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.

Sponsors and collaborators

Lead sponsor

Sara Espinoza

Other

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

Registry information

Acronym: INOSO

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 18, 2017
Registry last updated
Oct 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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