Clinical trial NCT03119610: The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity
Official title: The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Obesity
Sarcopenic Obesity
Sarcopenia
Aging
Sedentary Lifestyle
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center at San Antonio
name: The University of Texas Health Science Center, Houston
name: The University of Texas Medical Branch, Galveston
First posted: 2017-04-18
Enrollment: 23
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in Body Weight
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Change in Fat Mass
timeFrame: Baseline to 8 weeks
measure: Change in Body Mass Index
timeFrame: 8 weeks
measure: Change in Glucose Levels Measured Using the Glucose Tolerance Test
timeFrame: 8 weeks
measure: Change in Short Physical Performance Battery (SPPB)
timeFrame: Baseline to 8 weeks
measure: Change in HbA1c (Hemoglobin A1c)
timeFrame: Baseline to 8 weeks
measure: Change in Waist Circumference
timeFrame: Baseline to 8 weeks
measure: Change in Total Cholesterol
timeFrame: Baseline to 8 weeks
measure: Change in Low Density Lipoproteins (LDL)
timeFrame: Baseline to 8 weeks
measure: Change in High Density Lipoproteins (HDL)
timeFrame: Baseline to 8 weeks
measure: Change in Triglycerides
timeFrame: Baseline to 8 weeks
measure: Change in Center for Epidemiologic Studies Scale (CES-D)
timeFrame: Baseline to 8 weeks
measure: Change in Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline to 8 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Texas Diabetic Institute
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, San Antonio
name: Sara Espinoza, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.