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The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity

NCT ID: NCT03119610

Last Updated: 2021-10-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-22

Study Completion Date

2019-12-17

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity Sarcopenic Obesity Sarcopenia Aging Sedentary Lifestyle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo nasal spray

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

Group Type EXPERIMENTAL

Placebo nasal spray

Intervention Type DRUG

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

Oxytocin nasal spray

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

Group Type EXPERIMENTAL

Oxytocin nasal spray

Intervention Type DRUG

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

Interventions

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Oxytocin nasal spray

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

Intervention Type DRUG

Placebo nasal spray

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

Intervention Type DRUG

Other Intervention Names

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Intranasal oxytocin Syntocinon nasal spray Saline nasal spray

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role collaborator

Sara Espinoza

OTHER

Sponsor Role lead

Responsible Party

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Sara Espinoza

Associate Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sara Espinoza, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, San Antonio

Locations

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Texas Diabetic Institute

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 34029521 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HSC20160661H

Identifier Type: -

Identifier Source: org_study_id