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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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19 February 2015 |
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Main ID: |
NCT00337337 |
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Date of registration:
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14/06/2006 |
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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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Multiple Grain in Type 2 Diabetes
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Scientific title:
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Effect of Reconstitute Multiple Grain on Glucose and Lipid Metabolism in Patients With Type 2 Diabetes |
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Date of first enrolment:
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April 2005 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00337337 |
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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: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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HY Ou, MD |
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Address:
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Telephone:
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886-6-2353535 |
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Email:
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wahoryi@mail.ncku.edu.tw |
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Affiliation:
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Name:
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T-J Wu, 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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National Cheng-Kung University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Mentally competent adults of either sex with age 30-75 years old
- Patients have type 2 diabetes mellitus diagnosed after 25 years of age
- Patients have been in inadequate but stable glycemic control by diet. Inadequate
glycemic control isdefined as: HbA1c 7.1-11.0%
- Patients have signed the written informed consent.
Exclusion Criteria:
- Patients with type 1 diabetes mellitus
- Patients with alcohol, drugs or medications abuse considered by the investigator
- Patients with impaired liver function (AST, ALT>2.5× upper limit of normal)
- Patients with impaired kidney function (serum creatinine>3.0 mg/dl)
- Patients with emphysema or chronic bronchitis
- Patients with hepatic cirrhosis
- Patients with chronic intestinal diseases related to marked disorders of digestion or
absorption
- Patients participated investigational drug trial within 1 month before entering this
study
- Patients with any other serious diseases considered by the investigator not in the
condition to enter the trial
Age minimum:
25 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus
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Intervention(s)
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Behavioral: Ordinary Asian- rice
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Behavioral: Multiple grain
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Primary Outcome(s)
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Changes in glycemic parameters including fasting plasma glucose, postprandial plasma glucose, insulin sensitivity and lipid profile
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Secondary Outcome(s)
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Acceptabiliy and tolerability
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Changes in body weight
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Secondary ID(s)
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NCKU-94-032
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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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