Investigating the Stability, Variability and Mechanism of Incorporation of Lipid Mediators Into Eccrine Sweat

NCT02935894 | Completed Results

• 1 other identifier: 929370
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see what the differences are in sweat (amount and small molecule content) collected from different sites of the body and by different methods of sweat stimulation. Additionally, the investigators want to know whether the amount and small molecule content of the sweat is the same in an individual over time, and the same across individuals at a given time. Finally, the investigators want to know how consumption of over-the-counter anti-inflammatory drugs such as ibuprofen will affect the inflammatory mediator content of sweat and how that compares to blood. This information will help to better understand the composition and behavior of sweat and assess its potential utility as a routine clinical tool in skin research.

Conditions

Stability & Variability of Lipid-derived Molecules in Sweat

Keywords

oxygenated lipids; metabolic profiling; sphingoid bases; ceramides; endocannabinoids; non-invasive sampling

Outcome Measures

Primary Outcomes (5)

• Volar Forearm Sweat Lipid Mediator Concentrations Following Pilocarpine Stimulation

  Approximately 150 lipid mediators will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Assayed lipid mediators include oxygenated lipids, endocannabinoids and endocannabinoid-like molecules, and sphingolipids.

  measured at study visit 1, 2 and 3; detected lipid mediator concentrations for study visit 1 reported

• Volar Forearm Sweat Lipid Mediator Concentrations Following Exercise

  Approximately 150 lipid mediators will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Assayed lipid mediators include oxygenated lipids, endocannabinoids and endocannabinoid-like molecules, and sphingolipids.

  measured at study visit 1, detected lipid mediator concentrations reported

• Lower Back Sweat Lipid Mediator Concentrations Following Pilocarpine Stimulation

  Approximately 150 lipid mediators will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Assayed lipid mediators include oxygenated lipids, endocannabinoids and endocannabinoid-like molecules, and sphingolipids.

  measured at study visit 1, detected lipid mediator concentrations reported

• Anterior Distal Thigh Sweat Lipid Mediator Concentrations Following Pilocarpine Stimulation

  Approximately 150 lipid mediators will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Assayed lipid mediators include oxygenated lipids, endocannabinoids and endocannabinoid-like molecules, and sphingolipids.

  measured at study visit 2, detected lipid mediator concentrations reported

• Change in Plasma Lipid Mediator Concentrations Before and After Oral Ibuprofen Administration

  Approximately 100 lipid mediators will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Assayed lipid mediators include oxygenated lipids, endocannabinoids, and endocannabinoid-like molecules.

  measured at four timepoints at study visit 4, detected lipid mediator concentrations for first timepoint reported

Secondary Outcomes (3)

• Change in Pilocarpine-stimulated Sweat Lipid Mediator Concentrations Before and After Oral Ibuprofen Administration

  measured at four timepoints at study visit 4, detected lipid mediator concentrations for first timepoint reported

• Change in Plasma Ibuprofen Concentrations

  measured at four timepoints at study visit 4

• Change in Sweat Ibuprofen Concentrations

  measured at four timepoints at study visit 4

Study Arms (1)

Single group

EXPERIMENTAL

All subjects will participate in 4 study day visits in the same order. 1. compare sweat collected following pharmacological stimulation of sweating (using the drug pilocarpine) to sweat collected following physiological induction of sweating (exercise using a stationary bicycle). 2. compare sweat collected following stimulation of sweating by the drug pilocarpine from the inner part of the forearm (near the wrist) to upper surface of thigh (near the knee). 3. collect sweat following stimulation of sweating by the drug pilocarpine from the inner part of both forearms (near the wrist). 4. collect blood and sweat samples before and 30 minutes, 2 hours and 4 hours after consumption of 400 mg of ibuprofen.

Drug: Ibuprofen; Other: Physiological induction of sweating; Drug: Pilocarpine

Interventions

Ibuprofen DRUG

400 mg ibuprofen given to inhibit cyclooxygenase metabolism

Single group

Physiological induction of sweating OTHER

15 minutes exercise at 60-80% oxygen consumption to induce sweating

Also known as: Exercise

Single group

Pilocarpine DRUG

Iontophoresis with a 1.5 milliampere (mA) current using a gel disc containing a 5% pilocarpine nitrate solution to induce sweating

Also known as: Pilogel

Single group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Weight \> 110 pounds

You may not qualify if:

• Diagnosed active chronic diseases for which the individual is currently taking daily medication, including but not limited to:
• Diabetes mellitus
• Cardiovascular disease
• Cancer
• Gastrointestinal disorders
• Kidney disease
• Liver disease
• Bleeding disorders
• Asthma
• Autoimmune disorders
• Hypertension
• Osteoporosis
• Recent minor surgery (within 4 wk) or major surgery (within 16 wk)
• Recent antibiotic therapy (within 4 wk)
• Recent hospitalization (within 4 wk)

Sponsors & Collaborators

• USDA, Western Human Nutrition Research Center: lead
• University of California, Davis: collaborator

Study Sites (1)

Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

MeSH Terms

Interventions

Ibuprofen; Exercise; Pilocarpine

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. John W. Newman
• Organization: USDA, ARS Western Human Nutrition Research Center

john.newman@ars.usda.gov

530-752-1009

Study Officials

• John W. Newman, Ph.D.

  USDA-ARS-Western Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 18, 2016
• Study Start: November 28, 2016
• Primary Completion: June 8, 2017
• Study Completion: June 8, 2017
• Last Updated: June 1, 2018
• Results First Posted: June 1, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)