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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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ChiCTR |
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Last refreshed on:
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18 April 2017 |
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Main ID: |
ChiCTR-IPR-15006124 |
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Date of registration:
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2015-03-17 |
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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 supplementation of proanthocyanidins combined with vitamin C and E on type 2 diabetes
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Scientific title:
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Effect of supplementation of proanthocyanidins combined with vitamin C and E on type 2 diabetes |
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Date of first enrolment:
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2015-03-16 |
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Target sample size:
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Control group:27;Proanthocyanidins intervention group:27;Vc+Ve group:27;Proanthocyanidins+Vc+Ve group:27; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=10613 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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Pilot study
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Countries of recruitment
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China
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Contacts
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Name:
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Yu Li
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Address:
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30 Gaotanyan Street, Shapingba district, Chongqing
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Telephone:
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+86 18580498626 |
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Email:
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gyulilove.happy@163.com |
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Affiliation:
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Third Military Medical University |
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Name:
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Mi Mantian
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Address:
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30 Gaotanyan Street, Shapingba district, Chongqing
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Telephone:
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+86 13508305561 |
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Email:
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mimt@sina.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: According to anyone of the diagnostic criteria recommended by the American Diabetes Association in 2010, type 2 diabetes mellitus was diagnosed as:
1. Glycated hemoglobin higher than 6.5%*, or
2. Fasting plasma glucose higher than 7.0 mmol/L. Fasting is defined as at least 8h no calorie intake*, or
3. 2h-postgrandial glucose >=11.1 mmol/L in OGTT test*, or
4. With the typical symptoms of patients with hyperglycemia or hyperglycemia crisis, random blood glucose >=11.1 mmol/l.
(* In the absence of clear hyperglycemia, criteria 1-3 should be confirmed by repeat test)
And subjects also meet the following criteria:age between 40 to 65 years,diagnosed with type 2 diabetes at least for half a year, meet all ethical requirements and sign the informed consent form, live in Chongqing in the next 4 months and vist to the hospital conveniently.
Exclusion criteria: 1. Hyperthyroidism;
2. A short life expectancy with diseases such as malignant tumor;
3. serious complications of diabetes;
4. Severe chronic diseases or severe hepatic and renal dysfunction;
5. A history of severe hypoglycemia;
6. Patients with poor compliance.
Age minimum:
40
Age maximum:
65
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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Control group:Placebo;Proanthocyanidins intervention group:Proanthocyanidins;Vc+Ve group:Vc+Ve;Proanthocyanidins+Vc+Ve group:????+???C+???E;
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Primary Outcome(s)
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Fasting plasma glucose;
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Secondary Outcome(s)
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triglycerides;Total cholesterol;Low density lipoprotein cholesterol;High density lipoprotein cholesterol;Insulin;Glycated hemoglobin;
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Source(s) of Monetary Support
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By-health Co.,Ltd
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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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