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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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14 September 2015 |
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Main ID: |
NCT02543684 |
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Date of registration:
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03/09/2015 |
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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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Post-prandial Glucose and Insulin Levels in Type 2 Diabetes Mellitus Patients After Consumption of Ready-to-eat Mixed Meals
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Scientific title:
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Post-prandial Glucose and Insulin Levels in Type 2 Diabetes Mellitus Patients After Consumption of Ready-to-eat Mixed Meals |
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Date of first enrolment:
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November 2013 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02543684 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Phase:
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N/A
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Countries of recruitment
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Greece
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Contacts
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Name:
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Yannis Manios, Associate Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Harokopio University, Athens |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects are eligible if they are 45-75 years of age
- non-insulin-dependent T2DM with an elapsed time since diagnosis of more than 3 years
- Body Mass Index (BMI) value higher than 20 kg/m2
- HbA1c levels of 6.5 to 11%
Exclusion Criteria:
- insulin-dependent T2DM
- cardiovascular (i.e. coronary heart disease, stroke etc.)
- liver and/or renal disease
Age minimum:
45 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 2
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Intervention(s)
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Other: ready to eat mixed meal 2
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Other: oral glucose load
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Other: ready to eat mixed meal 3
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Other: ready to eat mixed meal 1
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Primary Outcome(s)
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serum glucose changes over time
[Time Frame: fasting baseline glucose at time 0, then 30, 60, 90, and 120 minutes postprandial]
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serum insulin changes over time
[Time Frame: fasting baseline insulin at time 0, then 30, 60, 90, and 120 minutes postprandial]
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Secondary ID(s)
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Diabetes study
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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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