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ObesityPhase 1/2INOSONCT03119610

The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity

A Phase 1/2 study testing Oxytocin nasal spray in people with Obesity and Sarcopenic Obesity, run by Sara Espinoza at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 99 years
Conditions the study is for
Obesity, Sarcopenic Obesity, Sarcopenia
What is being tested?
Oxytocin nasal spray
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
1 siteUnited States
Study dates
22 Sep 2017to 17 Dec 2019
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • BMI 30-40 kg/m2
  • Sedentary (< 2 strenuous exercise/week)
  • Gait speed < 1 meter/second

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Texas Diabetic Institute

    San Antonio, Texas, 78207

Other trials in United States

About this study

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.

Read the 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.

Being tested
Oxytocin nasal spray, Placebo nasal spray
Medical subject headings
Obesity, Sarcopenia, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxytocin nasal sprayDrug

    Also called Intranasal oxytocin, Syntocinon nasal spray

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

  • Placebo nasal sprayDrug

    Also called Saline nasal spray

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

Study groups in NCT03119610
Study groupRoleWhat they receive
Oxytocin nasal sprayExperimentalOxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered
Receives: Drug: Oxytocin nasal spray
Placebo nasal sprayExperimentalPlacebo nasal spray, 4x a day for 8 weeks, self administered
Receives: Drug: Placebo nasal spray

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Body Weight

    Intranasal oxytocin will promote weight loss and preserve muscle mass

    Measured: Baseline to 8 weeks

Secondary outcomes (12)

  1. 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

    Measured: Baseline to 8 weeks

  2. 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).

    Measured: 8 weeks

  3. 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

    Measured: 8 weeks

  4. 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:

    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.

    Measured: Baseline to 8 weeks

  5. Change in HbA1c (Hemoglobin A1c)

    Pre- and post-measurements will be examined for individual change with intranasal oxytocin

    Measured: Baseline to 8 weeks

  6. Change in Waist Circumference

    Pre- and post-measurements will be examined for individual change with intranasal oxytocin

    Measured: Baseline to 8 weeks

  7. Change in Total Cholesterol

    Pre- and post-measurements will be examined for individual change with intranasal oxytocin

    Measured: Baseline to 8 weeks

  8. Change in Low Density Lipoproteins (LDL)

    Pre- and post-measurements will be examined for individual change with intranasal oxytocin

    Measured: Baseline to 8 weeks

  9. Change in High Density Lipoproteins (HDL)

    Pre- and post-measurements will be examined for individual change with intranasal oxytocin

    Measured: Baseline to 8 weeks

  10. Change in Triglycerides

    Pre- and post-measurements will be examined for individual change with intranasal oxytocin

    Measured: Baseline to 8 weeks

  11. 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:

    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.

    Measured: Baseline to 8 weeks

  12. 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.

    Measured: Baseline to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2017
  2. Study start22 Sep 2017
  3. Primary completion17 Dec 2018
  4. Study completion17 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03119610
Sponsor's protocol ID
HSC20160661H
Acronym
INOSO
Status last verified
Sep 2020
First submitted
22 Mar 2017
Last updated
22 Oct 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34029521

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Oxytocin nasal spray in people with Obesity and Sarcopenic Obesity, run by Sara Espinoza at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body Weight (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03119610, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.

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