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NCT Number: NCT03149770

Naloxone, Hypoglycemia and Exercise

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naloxone then placebo

Drug

naloxone intranasal 4mg, then placebo

Placebo then Naloxone

Drug

placebo then naloxone intranasal 4mg

Primary outcomes

  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.

    the scale for symptoms score is 0-72. A higher score represents a better outcome.

  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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Hypoglycemia After Exercise in Type 1 Diabetes: Intranasal Naloxone as a Novel Therapy to Preserve Hypoglycemia Counterregulation

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
May 11, 2017
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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