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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: |
NCT00212290 |
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Date of registration:
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20/09/2005 |
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Primary sponsor: |
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Public title:
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Insulin Resistance and Central Nervous System (CNS) Function in Type 2 Diabetes
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Scientific title:
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Date of first enrolment:
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November 2002 |
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Target sample size:
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140 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00212290 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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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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Suzanne Craft, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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VA Puget Sound Health Care System, University of Washington |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Impaired glucose tolerance OR mild type 2 diabetes mellitus OR normal blood sugar
regulation
- Stable weight and activity level
Exclusion Criteria:
- Medications for diabetes
- Dementia
- Medications with known effects on memory
- Serious neurologic disease or head trauma
- Serious systemic illness (e.g., renal failure or uncontrolled hypertension)
- Serious psychiatric illness (e.g., schizophrenia or bipolar disorder)
- Allergy to pioglitazone or nateglinide
Age minimum:
55 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Insulin Resistance
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Type 2 Diabetes Mellitus
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Intervention(s)
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Drug: nateglinide
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Drug: pioglitazone
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Drug: placebo
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Primary Outcome(s)
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Beta-amyloid in spinal fluid (sub-study)
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Cerebral glucose metabolism (sub-study)
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Inflammatory markers in spinal fluid (sub-study)
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Plasma beta-amyloid levels (main study)
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Selective attention (main study)
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Verbal memory (main study)
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Secondary Outcome(s)
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Blood levels of insulin, insulin degrading enzyme, cortisol and inflammatory markers
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Psychomotor speed
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Verbal fluency
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Secondary ID(s)
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DK61606 (completed)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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