- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00608816
Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q4
December 10, 2014 updated by: Steve Davis, Vanderbilt University
Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 4
Epinephrine is one of the important hormones in the defense of hypoglycemia.
We will test the hypothesis that antecedent hypoglycemia will blunt the metabolic, neuroendocrine and cardiovascular effects of subsequent epinephrine infusion in Type 1 DM.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
When a person had previously experienced bouts of low blood sugar, or hypoglycemia, his or her counterregulatory responses to hypoglycemia would be weakened.
This is especially true and important for a person with Type 1 diabetes, because it will cause him or her to be vulnerable to another bout of hypoglycemia, and cause hypoglycemia unawareness, which can lead to serious or even life-threatening consequences.
Epinephrine is one of the important hormones in the defense of hypoglycemia.
We will test the hypothesis that antecedent hypoglycemia will blunt the metabolic, neuroendocrine and cardiovascular effects of subsequent epinephrine infusion in Type 1 DM.
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 28 (14 males, 14 females) conventionally treated Type 1 diabetic patients with HA1C > 8.5%
- 28 (14 males, 14 females) intensively treated Type 1 diabetic patients with HA1C < 7%
- 28 (14 males, 14 females) non-diabetic controls
- Age 18-45 yr.
- Had diabetes for 2-15 years if diabetic subject
- No clinical evidence of diabetic tissue complications, no cardiovascular disease
- Body mass index 21-27kg · m-2
- Normal bedside autonomic function
- Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities
- Female volunteers of childbearing potential: negative HCG pregnancy test
Exclusion Criteria:
- Prior history of poor health: any current or prior disease condition that alters carbohydrate metabolism and prior cardiac events and/or evidence for cardiac disease
- Hemoglobin of less than 12 g/dl
- Abnormal results following screening tests
- Pregnancy
- Subjects unable to give voluntary informed consent
- Subjects with a recent medical illness
- Subjects with known liver or kidney disease
- Subjects taking steroids
- Subjects taking beta blockers
- Subjects on anticoagulant drugs, anemic, or with known bleeding diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Hyperinsulinemic euglycemic glucose clamp study on day 1 Hyperinsulinemic euglycemic clamp study on day 2 with epinephrine infusion
|
Epinephrine 0.06 µg/kg/min infusion during a two hour experimental period on Day 2
Epinephrine 0.06 µg/kg/min infusion during two hour experimental period on Day 2
|
Experimental: 2
Hyperinsulinemic hypoglycemic glucose clamp x 2 on day 1 Hyperinsulinemic euglycemic clamp with epinephrine infusion on Day 2
|
Epinephrine 0.06 µg/kg/min infusion during a two hour experimental period on Day 2
Epinephrine 0.06 µg/kg/min infusion during two hour experimental period on Day 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
catecholamine levels
Time Frame: 2 days
|
2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
January 23, 2008
First Submitted That Met QC Criteria
January 23, 2008
First Posted (Estimate)
February 6, 2008
Study Record Updates
Last Update Posted (Estimate)
December 11, 2014
Last Update Submitted That Met QC Criteria
December 10, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Nervous System Diseases
- Autonomic Nervous System Diseases
- Primary Dysautonomias
- Hypoglycemia
- Pure Autonomic Failure
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Epinephrine
- Racepinephrine
- Epinephryl borate
Other Study ID Numbers
- IRB #040910-HAAF in T1DM, Q4
- Ro1 DK06903-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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