- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00592670
Hypoglycemia Associated Autonomic Failure in Type 1 DM
Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 6
Study Overview
Detailed Description
Because selective serotonin reuptake inhibitors are commonly prescribed to treat depression, it is vital to understand how these antidepressants affect hypoglycemia- the most feared complication in diabetes. This study's aim is to determine whether individuals who are chronically taking selective serotonin reuptake inhibitors have a reduced ability to defend against hypoglycemia compared to individuals not taking the medication, thus leaving them more susceptible to hypoglycemia. Both healthy volunteers and volunteers with type 1 diabetes mellitus will be studied. The results could potentially be important to diabetic patients, by demonstrating to physicians how to modify therapy for those taking antidepressants in order to avoid hypoglycemia.
The known effects of SSRI on the hypothalamo pituitary axis(HPA)may be important to the counterregulation of hypoglycemia. Prior research has demonstrated in healthy volunteers that antecedent increases in plasma cortisol result in significant blunting of neuroendocrine and autonomic responses to subsequent hypoglycemia. Thus, by activating the HPA axis, SSRIs could cause blunting of the counterregulatory response to hypoglycemia.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232-0475
- Vanderbilt University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 16 (8 males, 8 females) healthy volunteers aged 18-45 yr
- 34 (17 males, 17 females) type 1 diabetes volunteers aged 18-45 yr
- Body mass index 21-30 kg • 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
- Volunteers over 40 years old: normal heart tracing recorded while resting and walking on the treadmill
- For those with type 1 diabetes: HbA1c > 7.0%
- For those with type 1 diabetes: had diabetes for 2-15 years
- For those with type 1 diabetes: no clinical evidence of diabetic tissue complications
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 with any indication of depression, anxiety, bipolar, panic, or eating disorders
- Subjects with a past medical history or family history of mania or bipolar disorders
- 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
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Baseline measures followed by a randomized 6 weeks treatment of Prozac.
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20 mg fluoxetine orally one per day for 1 week, 40 mg fluoxetine orally once per day for one week, 80 mg Fluoxetine orally for remaining 4 weeks of treatment
Other Names:
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Placebo Comparator: 2
Baseline followed by a 6 week randomized treatment of placebo.
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20 mg placebo pill taken orally once per day for one week, 40 mg placebo pill taken orally one per day for one week, 80 mg placebo pill taken orally once per day for remaining 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Catecholamine measures
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Fluoxetine
Other Study ID Numbers
- IRB#040912-HAAF-T1DM-Q6
- DK69803
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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