Phase 2
N=23
The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity
Obesity · Sarcopenic Obesity · Sarcopenia · Aging · Sedentary Lifestyle
Bottom Line
View on ClinicalTrials.gov: NCT03119610 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Change in Body Weight — 0.54; 0.04 Kilograms
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oxytocin nasal spray (Drug); Placebo nasal spray (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Sara Espinoza
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Weight |
0.54; 0.04 | — |
| SECONDARY Change in Fat Mass |
-0.2; -0.1 | — |
| SECONDARY Change in Body Mass Index |
36.8; 36.8 | — |
| SECONDARY Change in Glucose Levels Measured Using the Glucose Tolerance Test |
3.36; 2.85; -3.15; -3.375 | — |
| SECONDARY Change in Short Physical Performance Battery (SPPB) |
0.5; 0.625 | — |
| SECONDARY Change in HbA1c (Hemoglobin A1c) |
-0.05; 0.286 | — |
| SECONDARY Change in Waist Circumference |
-0.6958; -1.373 | — |
| SECONDARY Change in Total Cholesterol |
-11.18; -1.143 | — |
| SECONDARY Change in Low Density Lipoproteins (LDL) |
-8.727; 4.1429 | — |
| SECONDARY Change in High Density Lipoproteins (HDL) |
1.000; 0.1429 | — |
| SECONDARY Change in Triglycerides |
-16.82; -26.29 | — |
| SECONDARY Change in Center for Epidemiologic Studies Scale (CES-D) |
-1.375; 0.2222 | — |
| SECONDARY Change in Montreal Cognitive Assessment (MoCA) |
1.0000; 0.4444 | — |
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.
Eligibility Criteria
Inclusion Criteria
- BMI 30-40 kg/m2
- Sedentary ( 170 or DBP >95 mm/Hg)
- Anemia (Hematocrit 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
Data sourced from ClinicalTrials.gov (NCT03119610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.