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| Sponsored by: |
Vanderbilt University |
|---|---|
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00605774 |
Purpose
When a patient with Type 1 diabetes exercises, he or she is more prone to low blood sugar, or hypoglycemia. It is known that antecedent exercise can blunt defense responses, called counterregulatory responses to subsequent hypoglycemia in Type 1 DM, causing him or her to be vulnerable to another bout of hypoglycemia. Epinephrine is one of the important hormones in the defense of blood glucose during both exercise and hypoglycemia. We will test the hypothesis that antecedent exercise will blunt the metabolic, neuroendocrine and cardiovascular effects of subsequent epinephrine infusion in Type 1 DM.
| Condition | Intervention |
|---|---|
|
Type 1 Diabetes |
Drug: epinephrine |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Active Control, Crossover Assignment |
| Official Title: | Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 5 |
| Estimated Enrollment: | 84 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Hyperinsulinemic euglycemic glucose clamps x 2 on Day 1 Hyperinsulinemic euglycemic glucose clamp with epinephrine infusion on Day 2
|
Drug: epinephrine
Epinephrine 0.06 µg/kg/min infused over two hours during experimental period on Day 2
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2: Experimental
Day 1 euglycemic exercise period x 2 Day 2 hyperinsulinemic euglycemic glucose clamp with epinephrine infusion
|
Drug: epinephrine
Epinephrine 0.06 µg/kg/min infusion during hyperinsulinemic euglycemic clamp on day 2
|
We have recently performed studies to determine whether the critical metabolic actions of epinephrine are blunted in Type 1 DM. These studies have obvious clinical relevance because strategies aimed at increasing circulating levels of epinephrine will not be effective if the metabolic counterregulatory mechanisms (increased endogenous glucose production (EGP), increased lipolysis and reduced glucose uptake) of the hormone are also blunted.
Epinephrine was infused to reach circulating levels of ~ 1000 pg/ml (This level of epinephrine is equivalent to values of the hormone observed during hypoglycemia of 50 mg/dl in healthy males and T1DM men with average glucose control) in groups of either intensively treated (HBA1C < 7.0%), conventionally treated (HBA1C > 9.0%) type
1 DM and age, weight matched healthy controls. In the intensively treated DM group, epinephrine's actions to increase EGP, lipolysis and to restrain glucose uptake were significantly reduced (<60%). The mechanism for our finding needs to be determined. Our hypothesis is that antecedent exercise can cause repetitive activations of Autonomic-adrenomedullary responses that lead to downregulation of β-adrenoreceptor mechanisms. Therefore, the combination of blunted epinephrine effects, increased insulin action and reduced levels of the catecholamine might fully explain the vexing clinical question of post exercise hypoglycemia in Type 1 DM. In this application, we will test the hypothesis that antecedent exercise will blunt the metabolic, neuroendocrine and cardiovascular effects of subsequent epinephrine infusion in Type 1 DM.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Donna Tate | 615-936-1824 | donna.tate@vanderbilt.edu |
| Principal Investigator: | Stephen N. Davis, MD | Vanderbilt University |
More Information
| Responsible Party: | Vanderbilt University ( Stephen N. Davis, MD ) |
| Study ID Numbers: | IRB #040911- HAAF in T1DM, Q5, RO1 DK 069803-03 |
| Study First Received: | January 18, 2008 |
| Last Updated: | July 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00605774 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
catecholamines diabetes exercise |
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Neurotransmitter Agents Adrenergic alpha-Agonists Metabolic Diseases Autoimmune Diseases Adrenergic beta-Agonists Adrenergic Agents Diabetes Mellitus Anti-Asthmatic Agents Endocrine System Diseases Diabetes Mellitus Type 1 Cardiovascular Agents |
Hypoglycemia Adrenergic Agonists Mydriatics Diabetes Mellitus, Type 1 Vasoconstrictor Agents Endocrinopathy Peripheral Nervous System Agents Glucose Metabolism Disorders Epinephrine Bronchodilator Agents Metabolic Disorder |
|
Respiratory System Agents Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hypoglycemia Adrenergic Agonists Therapeutic Uses Vasoconstrictor Agents Epinephrine Autoimmune Diseases Metabolic Diseases Adrenergic alpha-Agonists Immune System Diseases |
Adrenergic beta-Agonists Sympathomimetics Diabetes Mellitus Anti-Asthmatic Agents Endocrine System Diseases Cardiovascular Agents Pharmacologic Actions Mydriatics Diabetes Mellitus, Type 1 Autonomic Agents Peripheral Nervous System Agents Glucose Metabolism Disorders Bronchodilator Agents |
