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

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ClinicalTrials.gov Identifier: NCT02935894
Recruitment Status : Completed
First Posted : October 18, 2016
Results First Posted : June 1, 2018
Last Update Posted : June 1, 2018
Sponsor:
Collaborator:
University of California, Davis
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center

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.

Condition or disease Intervention/treatment Phase
Stability & Variability of Lipid-derived Molecules in Sweat Drug: Ibuprofen Other: Physiological induction of sweating Drug: Pilocarpine Not Applicable

Detailed Description:
Subjects will participate in 4 study day visits that will be scheduled about 1- week apart. During the first study visit, the investigators will compare sweat collected following pharmacological stimulation of sweating (using the drug pilocarpine) to sweat collected following physiological stimulation of sweating (using a stationary bicycle). During the second study visit, the investigators will collect sweat following stimulation of sweating by the drug pilocarpine from the inner part of the forearm (near the wrist) and also the upper surface of the thigh (near the knee). During the third study visit, the investigators will collect sweat following stimulation of sweating by the drug pilocarpine from the inner part of both forearms (near the wrist). During the fourth study visit, the investigators will collect a sweat sample following stimulation of sweating by the drug pilocarpine from the inner part of the forearm (near the wrist) and a blood sample (about one teaspoon) from the other arm. After blood and sweat collection, participants will consume 400 mg (two tablets) of ibuprofen. The investigators will then collect blood and sweat from 30 minutes, 2 hours and 4 hours after participants consume the ibuprofen.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Investigating the Stability, Variability and Mechanism of Incorporation of Lipid Mediators Into Eccrine Sweat
Actual Study Start Date : November 28, 2016
Actual Primary Completion Date : June 8, 2017
Actual Study Completion Date : June 8, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat

Arm Intervention/treatment
Experimental: Single group

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
400 mg ibuprofen given to inhibit cyclooxygenase metabolism

Other: Physiological induction of sweating
15 minutes exercise at 60-80% oxygen consumption to induce sweating
Other Name: Exercise

Drug: Pilocarpine
Iontophoresis with a 1.5 milliampere (mA) current using a gel disc containing a 5% pilocarpine nitrate solution to induce sweating
Other Name: Pilogel




Primary Outcome Measures :
  1. Volar Forearm Sweat Lipid Mediator Concentrations Following Pilocarpine Stimulation [ Time Frame: measured at study visit 1, 2 and 3; detected lipid mediator concentrations for study visit 1 reported ]
    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.

  2. Volar Forearm Sweat Lipid Mediator Concentrations Following Exercise [ Time Frame: measured at study visit 1, detected lipid mediator concentrations reported ]
    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.

  3. Lower Back Sweat Lipid Mediator Concentrations Following Pilocarpine Stimulation [ Time Frame: measured at study visit 1, detected lipid mediator concentrations reported ]
    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.

  4. Anterior Distal Thigh Sweat Lipid Mediator Concentrations Following Pilocarpine Stimulation [ Time Frame: measured at study visit 2, detected lipid mediator concentrations reported ]
    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.

  5. Change in Plasma Lipid Mediator Concentrations Before and After Oral Ibuprofen Administration [ Time Frame: measured at four timepoints at study visit 4, detected lipid mediator concentrations for first timepoint reported ]
    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.


Secondary Outcome Measures :
  1. Change in Pilocarpine-stimulated Sweat Lipid Mediator Concentrations Before and After Oral Ibuprofen Administration [ Time Frame: measured at four timepoints at study visit 4, detected lipid mediator concentrations for first timepoint reported ]
    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.

  2. Change in Plasma Ibuprofen Concentrations [ Time Frame: measured at four timepoints at study visit 4 ]
    Plasma concentration of ibuprofen prior to and 30 min, 2 hr and 4 hr after oral administration

  3. Change in Sweat Ibuprofen Concentrations [ Time Frame: measured at four timepoints at study visit 4 ]
    Sweat concentration of ibuprofen prior to and 30 min, 2 hr and 4 hr after oral administration



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 20-40 y
  • Male
  • Weight > 110 pounds

Exclusion Criteria:

  • 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)
  • Use of over-the-counter or prescription medications at the time of the study that directly affect endpoints of interest (e.g. hyperlipidemia, glycemic control, steroids, statins, anti-inflammatory agents, and weight loss aids)
  • Adults who are not able to consent
  • Under current medical supervision
  • Ibuprofen intolerance or allergy
  • Those with a bleeding disorder
  • Current enrollee in a clinical research study.
  • Individuals with blood clotting or platelet defect disorders
  • Individuals with orthopedic limitations or cardiovascular risk that preclude participation in the physiological stimulation of sweat by light exercise portion of the study
  • Individuals who are trained athletes or that regularly perform physical activity defined as "vigorous" by the Centers for Disease Control and Prevention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02935894


Locations
United States, California
Western Human Nutrition Research Center
Davis, California, United States, 95616
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
University of California, Davis
Investigators
Principal Investigator: John W. Newman, Ph.D. USDA-ARS-Western Human Nutrition Research Center
  Study Documents (Full-Text)

Documents provided by USDA, Western Human Nutrition Research Center:
Study Protocol  [PDF] February 9, 2017
Informed Consent Form  [PDF] February 13, 2017
Statistical Analysis Plan  [PDF] December 5, 2017


Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT02935894     History of Changes
Other Study ID Numbers: 929370
First Posted: October 18, 2016    Key Record Dates
Results First Posted: June 1, 2018
Last Update Posted: June 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by USDA, Western Human Nutrition Research Center:
oxygenated lipids
metabolic profiling
sphingoid bases
ceramides
endocannabinoids
non-invasive sampling

Additional relevant MeSH terms:
Ibuprofen
Pilocarpine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Miotics
Autonomic Agents
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents