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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01416649 |
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Date of registration:
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11/08/2011 |
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Primary sponsor: |
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Public title:
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Impact of Exenatide on Sleep Duration
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Scientific title:
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Impact of Exenatide on Sleep Duration and Quality in Type 2 Diabetes |
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Date of first enrolment:
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February 2011 |
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Target sample size:
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12 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01416649 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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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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Annette Miller, MSN |
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Address:
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Telephone:
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773-834-8871 |
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Email:
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amiller@medicine.bsd.uchicago.edu |
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Affiliation:
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Name:
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Annette Miller, MSN |
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Address:
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Telephone:
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773-834-8871 |
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Email:
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amiller@medicine.bsd.uchicago.edu |
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Affiliation:
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Name:
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Silvana Pannain, MD |
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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 Chicago |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Patients taking diabetes medications other then insulin will be included, but changes to
their medications may be made as deemed necessary by their physician. Patients on stable
medications for chronic and co-morbid conditions (high blood pressure, high cholesterol,
etc) will be eligible
Exclusion Criteria:
Patients with moderate or severe kidney disease and history of pancreatitis or patients on
insulin will be excluded, as Exenatide use is contraindicated or risky in these
conditions.
Patients with unstable cardiac, neurological or psychiatric disease and women who are
pregnant or trying to get pregnant will be excluded. Patients who have severe COPD,
severe neuropathy or chronic pain, which could impair sleep, will be excluded. Shift
workers will be also excluded.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes
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Intervention(s)
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Drug: Exenatide
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Primary Outcome(s)
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Sleep duration and sleep efficiency
[Time Frame: at the end of 3 months of treatment with the medication]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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