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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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24 August 2015 |
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Main ID: |
NCT02470455 |
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Date of registration:
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04/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Atorvastatin on Glycemic Control in Prediabetic Patients
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Scientific title:
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Effect of Atorvastatin on Glycemic Control in Prediabetic Patients |
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Date of first enrolment:
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July 2011 |
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Target sample size:
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75 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02470455 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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Countries of recruitment
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India
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Contacts
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Name:
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TRUPTI R SWAIN, 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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SCB Medical College, Cuttack, Odisha |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Any patient on statins therapy whose blood sugar level is within normal limit.
- Pre-diabetic patients (IFG and/or IGT) on statins
- Patients who agreed to participate in the study and signed the informed consent form
without any external motivation
Exclusion Criteria:
- Diagnosed cases of DM, both type I and II, on different anti-diabetic regimen
- Patients on ß-blockers, thiazide diuretics, corticosteroids, which can affect blood
sugar level
- Pregnancy and lactation
- Co-existing or other organ involvement like kidney, liver which can affect blood
sugar level
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Prediabetic State
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Intervention(s)
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Drug: Atorvastatin
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Primary Outcome(s)
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Change in Glycosylated Hemoglobin (HbA1c) from baseline
[Time Frame: At baseline and at 6 monhts, 12 months and 18 months follow up]
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Secondary Outcome(s)
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Change in Post prandial blood sugar from baseline
[Time Frame: At baseline and at 6 monhts, 12 months and 18 months follow up]
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Lipid profile
[Time Frame: At baseline]
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Change in Fasting blood sugar from baseline
[Time Frame: At baseline and at 6 monhts, 12 months and 18 months follow up]
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Secondary ID(s)
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IEC/SCB/Pharma/2011/05
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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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