Naloxone, Hypoglycemia and Exercise
| Status: | Recruiting |
|---|---|
| Conditions: | Endocrine, Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/13/2018 |
| Start Date: | September 18, 2017 |
| End Date: | December 2020 |
| Contact: | Anjali Kumar, PA-C |
| Email: | studydiabetes@umn.edu |
| Phone: | 612-301-7040 |
Hypoglycemia After Exercise in Type 1 Diabetes: Intranasal Naloxone as a Novel Therapy to Preserve Hypoglycemia Counterregulation
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.
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.
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
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