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Collection of Breath and Sweat to Identify Indicators of Hypoglycemia

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ClinicalTrials.gov Identifier: NCT03600116
Recruitment Status : Unknown
Verified November 2018 by Steven J. Russell, MD, PhD, Massachusetts General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : July 26, 2018
Last Update Posted : December 3, 2018
Sponsor:
Collaborator:
Mitre Medical Corp.
Information provided by (Responsible Party):
Steven J. Russell, MD, PhD, Massachusetts General Hospital

Brief Summary:
Breath and sweat samples will be collected at intervals throughout the visit, with increased frequency during hypoglycemia. Collaborators with the MITRE Corporation will perform analyses on these samples to identify any relationships between volatile organic compounds in breath and sweat and hypoglycemia.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Insulin Lispro Phase 2

Detailed Description:
The investigators will measure volatile organic compounds in breath and sweat of participants with type 1 diabetes with normoglycemia and induced hypoglycemia to determine if there is a relationship between VOC signature and hypoglycemia. The investigators will administer an insulin injection to provoke mild hypoglycemia and thereby increase the number of breath and sweat samples collected under hypoglycemic conditions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Collection of Breath and Sweat to Identify Indicators of Hypoglycemia
Actual Study Start Date : May 24, 2018
Actual Primary Completion Date : November 20, 2018
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia Sweat

Arm Intervention/treatment
Study Visit
Subjects will arrive to the study visit having fasted the night before. Subjects will be given an insulin injection based on their meal to carbohydrate ratio for their breakfast meal as well as a correction bolus to correct their current plasma glucose value down to 40 mg/dL. Following the insulin injection, subjects will eat breakfast. Blood, breath, and sweat samples will be collected throughout the study visit with increased frequency of collection during hypoglycemia. After subjects reach the hypoglycemia threshold, they will be allowed to eat and drink and their blood sugar will be monitored for stability prior to discharge.
Drug: Insulin Lispro
Subjects will be given an insulin injection with insulin lispro (Humalog) to correct them for their breakfast meal and to correct their plasma glucose value down to 40mg/dL.
Other Name: Humalog




Primary Outcome Measures :
  1. Identification of Volatile Organic Chemical Indicators of Hypoglycemia [ Time Frame: Up to 12 months ]
    Exploration via chemical analysis of clinical samples taken from diabetics' breath and sweat, using gas chromatograph-mass spectrometry (GC-MS) and liquid chromatograph-mass spectrometry (LC-MS), to determine the volatile organic compounds whose varying concentrations might correlate with diabetics' blood sugar concentrations in the normoglycemic and hypoglycemic ranges.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Informed consent by the subject documented prior to any study procedures
  • Age ≥ 18 years
  • Have had clinical type 1 diabetes for at least one year
  • Willing and able to avoid deodorant, scented lotions, and scented laundry detergent on your clothes on the day of the visit

Exclusion Criteria:

  • Unable to provide informed consent (e.g. impaired cognition or judgment)
  • Unable to safely comply with study procedures and reporting requirements (e.g. impaired memory or unable to speak and read English)
  • Current participation in another diabetes-related clinical trial that, in the judgment of the principal investigator, will compromise the results of this study or the safety of the subject
  • Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception

    • Subjects must use acceptable contraception for the two weeks prior to the study, throughout the study and for the two weeks following the study.
    • Acceptable contraception methods include:
    • Oral contraceptive pill (OCP)
    • Intrauterine Device (IUD, hormonal or copper)
    • Male condoms
    • Female condoms
    • Diaphragm or cervical cap with spermicide
    • Contraceptive patch (such as OrthoEvra)
    • Contraceptive implant (such as Implanon, Nexplanon)
    • Vaginal ring (such as NuvaRing)
    • Progestin shot (such as Depo-Provera)
    • Male partner with a vasectomy proven to be effective by semen analysis
  • Abnormal EKG consistent with coronary artery disease or increased risk of malignant arrhythmia including, but not limited to, evidence of active ischemia, prior myocardial infarction, proximal LAD critical stenosis (Wellen's sign), prolonged QT interval (> 440 ms). Non-specific ST segment and T wave changes are not grounds for exclusion in the absence of symptoms or history of heart disease. A reassuring evaluation by a cardiologist after an abnormal EKG finding may allow participation.
  • History of hypoglycemic seizures (grand mal) or coma in the last year
  • History of poor venous access or inadequate venous access as determined by trial nurse or physician at time of screening
  • Hemoglobin < 12 g/dl for men, < 11 g/dl for women
  • Any factors that, in the opinion of the principal investigator would interfere with the safe completion of the study

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): NCT03600116


Locations
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United States, Massachusetts
Massachusetts General Hospital (MGH) Diabetes Research Center
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Mitre Medical Corp.
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Responsible Party: Steven J. Russell, MD, PhD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03600116    
Other Study ID Numbers: 2018P000868
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The study data may be shared with collaborators at the MITRE Corporation (a non-profit research corporation), but only in a form in which all personally identifiable information has been removed. Shared data will be in the form of a database in which only a number identifies subjects.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Hypoglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs