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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 February 2024 |
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Main ID: |
NCT01672255 |
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Date of registration:
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17/08/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus (DM)
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Scientific title:
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Hypoglycemia Associated Autonomic Failure in Type 1 DM, SSRI and Exercise |
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Date of first enrolment:
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October 2012 |
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Target sample size:
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64 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT01672255 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Early Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Maka Siamashvili, MD |
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Address:
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Telephone:
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410-706-5623 |
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Email:
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Affiliation:
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Name:
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Stephen N. Davis, MBBS |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Maryland, Baltimore |
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Name:
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Maka Siamashvili, MD |
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Address:
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Telephone:
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410-706-5623 |
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Email:
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msiamashvili@som.umaryland.edu |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 32 (16 males, 16 females) Healthy controls aged 18-45 yr.
- 32 (16 males, 16 females) Type 1 diabetic patients aged 18-45 yr.
- HbA1c 6-10.0%
- Has been diagnosed Type 1 DM
- No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy,
neuropathy, stasis ulcers, etc)
- Body mass index < 40kg • m-2
Exclusion Criteria:
- Pregnant women
- Subjects unable to give voluntary informed consent
- Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
- Subjects taking any of the following medications will be excluded: Non-selective Beta
Blockers, Sedative-Hypnotics, Anticonvulsants, Antiparkinsonian drugs, Antipsychotics,
Antidepressants, Mood stabilizers, CNS Stimulants, Opioids, Hallucinogens
- Subjects with a recent medical illness
- Subjects with a history of hypertension, heart disease, cerebrovascular incidents
- Current tobacco use
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Type 1 Diabetes
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Hypoglycemia Associated Autonomic Failure
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Intervention(s)
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Drug: Fluoxetine
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Drug: Placebo control
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Primary Outcome(s)
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Change in Catecholamines
[Time Frame: During 90 minute experimental period]
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Secondary ID(s)
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HP-00044537; SSRI and Exercise
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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