The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity

NCT03119610 | Completed Phase 1 Results FDA Drug

• 1 other identifier: HSC20160661H
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Sarcopenic Obesity; Sarcopenia; Aging; Sedentary Lifestyle

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight

  Intranasal oxytocin will promote weight loss and preserve muscle mass

  Baseline to 8 weeks

Secondary Outcomes (12)

• Change in Fat Mass

  Baseline to 8 weeks

• Change in Body Mass Index

  8 weeks

• Change in Glucose Levels Measured Using the Glucose Tolerance Test

  8 weeks

• Change in Short Physical Performance Battery (SPPB)

  Baseline to 8 weeks

• Change in HbA1c (Hemoglobin A1c)

  Baseline to 8 weeks

Study Arms (2)

Oxytocin nasal spray

EXPERIMENTAL

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

Drug: Oxytocin nasal spray

Placebo nasal spray

EXPERIMENTAL

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

Drug: Placebo nasal spray

Interventions

Oxytocin nasal spray DRUG

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

Also known as: Intranasal oxytocin, Syntocinon nasal spray

Oxytocin nasal spray

Placebo nasal spray DRUG

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

Also known as: Saline nasal spray

Placebo nasal spray

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sara Espinoza: lead
• The University of Texas Health Science Center at San Antonio: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• The University of Texas Medical Branch, Galveston: collaborator

Study Sites (1)

Texas Diabetic Institute

San Antonio, Texas, 78207, United States

Location

Related Publications (1)

• 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.

  PMID: 34029521 RESULT

MeSH Terms

Conditions

Obesity; Sarcopenia; Sedentary Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Behavior

Results Point of Contact

• Title: Sara Espinoza, MD
• Organization: UT Health San Antonio

espinozas2@uthscsa.edu

210-617-5197

Study Officials

• Sara Espinoza, MD

  The University of Texas Health Science Center, San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 18, 2017
• Study Start: September 22, 2017
• Primary Completion: December 17, 2018
• Study Completion: December 17, 2019
• Last Updated: October 22, 2021
• Results First Posted: October 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)