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Naloxone, Hypoglycemia and Exercise

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ClinicalTrials.gov Identifier: NCT03149770
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
The overall objective of this project is to determine if the intranasal administration of naloxone during exercise will be a novel approach to preserve the counterregulatory response to hypoglycemia experienced the next day in patients with type 1 diabetes. Exercise induced autonomic failure contributes to the development of impaired awareness of hypoglycemia. Treatments that blunt the consequences of exercise induced autonomic failure, such as preserving the post-exercise counterregulatory response to hypoglycemia, may improve awareness of hypoglycemia. Naloxone, an opioid antagonist, is an extremely promising agent. In healthy volunteers, intravenous administration of naloxone during exercise preserved the counterregulatory response to hypoglycemia the following day (1). In this study, investigators will extend the clinical applicability by administering intranasal naloxone to individuals with type 1 diabetes. Specifically, the investigators will use a randomized, placebo controlled, crossover design to administer drug or placebo to patients with type 1 diabetes during acute exercise and assess the counterregulatory response to hypoglycemia the following day. The use of intranasal naloxone is a highly innovative aspect of this proposal. Intranasal naloxone translates readily to clinical use and, as demonstrated by the investigators preliminary data, achieves similar plasma drug concentrations as after IV administration.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Naloxone Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hypoglycemia After Exercise in Type 1 Diabetes: Intranasal Naloxone as a Novel Therapy to Preserve Hypoglycemia Counterregulation
Actual Study Start Date : September 18, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Naloxone, intranasal 4mg
Drug: Naloxone
naloxone vs placebo

Placebo Comparator: 2
Placebo
Drug: Placebo
placebo vs naloxone




Primary Outcome Measures :
  1. Change in Symptom Score [ Time Frame: Day 2 ]
    The primary outcome variable for Aim 1 will be the difference, naloxone vs. saline, in symptom scores collected using a standard questionnaire during the hypoglycemic clamp on Day 2, after administration of intranasal treatment during exercise on Day 1.

  2. Change in Epinephrine Levels [ Time Frame: Day 2 ]
    The primary outcome variable for Aim 2 will be the difference, naloxone vs. saline, in peak epinephrine levels measured during the hypoglycemic clamp on Day 2, after administration of treatment during exercise on Day 1.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes diagnosed on clinical grounds (history of DKA, use of insulin within 6 months of diagnosis)
  • Diabetes duration < 30 years (impaired awareness of hypoglycemia increases with duration so it will be more likely that shorter duration participants will have hypoglycemia awareness) but > 2 years (to ensure that they have lost hypoglycemia induced glucagon secretion as is typical in patients who develop impaired awareness of hypoglycemia)
  • Age 18 - 65 years
  • Baseline hemoglobin A1C 6.8 - 9.0% (range selected to reduce the risk of hypoglycemia and uncontrolled diabetes in the weeks before the study, both of which may affect the responses to hypoglycemia)
  • Awareness of hypoglycemia as verified by Cox questionnaire

Exclusion Criteria:

  • History of stroke, seizures (other than those related to hypoglycemia), arrhythmias, active cardiac disease
  • History of hypertension or blood pressure > 140/95 mm Hg at screening visit
  • Pregnancy or plan to become pregnant during the study period
  • Health related limitations in exercise (including but not limited to: angina, uncontrolled asthma, peripheral arterial disease)
  • Unwillingness to avoid exercise during the 7 days before each part of the study
  • Concomitant medical problems that may prevent the participant from successfully completing the protocol
  • Smoking as defined by 2 or more tobacco cigarettes a week
  • Daily use of opioids or an opioid antagonist or use in the past two weeks
  • Unwillingness to wear a continuous glucose monitor for one week before and one week after each part 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): NCT03149770


Contacts
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Contact: Anjali Kumar, PA-C 612-301-7040 studydiabetes@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Anjali Kumar, PA-C    612-301-7040    studydiabetes@umn.edu   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Elizabeth Seaquist, MD University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03149770     History of Changes
Other Study ID Numbers: Study00000026
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Hypoglycemia
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents