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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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TCTR |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
TCTR20141208001 |
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Date of registration:
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08/12/2014 |
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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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Diabetes Mellitus treated with Medical Nutritional Therapy and Self Blood Glucose Monitoring
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Scientific title:
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Individualized Medical Nutritional Therapy with Self Blood Glucose Monitoring in Patients with Type 2 Diabetes who are not Using Insulin |
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Date of first enrolment:
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30/07/2014 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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https://www.thaiclinicaltrials.org/show/TCTR20141208001 |
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Study type:
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Interventional |
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Study design:
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Randomized
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Phase:
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Phase 4
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Kanchana
Ngaosuwan |
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Address:
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Endocrinology and Metabolism unit, Department of Medicine, HRH Princess Maha Chakri Sirindhorn Medic
26120
Nakhon Nayok
Thailand |
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Telephone:
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+6637+395085 |
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Email:
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Dream.kanchana@gmail.com |
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Affiliation:
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Faculty of Medicine, Srinakharinwirot University |
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Name:
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Kanchana
Ngaosuwan |
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Address:
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Endocrinology and Metabolism unit, Department of Medicine, HRH Princess Maha Chakri Sirindhorn Medic
26120
Nakhon Nayok
Thailand |
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Telephone:
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+6637+395085 |
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Email:
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Dream.kanchana@gmail.com |
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Affiliation:
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Faculty of Medicine, Srinakharinwirot University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. diagnosis of type 2 diabetes
2. Hemoglobin A1C more than 6.5 % within 3 months before enrollment
Exclusion criteria: 1. Hemoglobin A1C more than 9% within 3 months before enrollment
2. insulin or Glucagon-like peptide-1 agonist users
3. Liver cirrhosis
4. Pregnancy or expected to pregnant within 1 year
5. Receive tube feeding
6. Glomerular filtration rate less than 60 ml/min/1.73m2
Age minimum:
18 Years
Age maximum:
0 N/A (No limit)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Glycemic control
Reduction of body weight
Lipid control
Medical nutrition therapy
Self blood glucose monitoring
type 2 diabetes
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Medical nutrition therapy
Self blood glucose monitoring
type 2 diabetes
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Intervention(s)
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We give individualized medical nutritional therapy together with self blood glucose monitoring for this arm.
Both arms are received their own and unchanged diabetic medications.
For safety issue, both arms may be decrease in diabetic medications, if feasible with hypoglycemia,We give our usual care to patients with type 2 diabetes.
Both arms are received their own and unchanged diabetic medications.
For safety issue, both arms may be decrease in diabetic medications, if feasible with hypoglycemia
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Experimental Behavioral,No Intervention Other
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Medical nutritional therapy plus Self blood glucose monitoring,Usual care
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Primary Outcome(s)
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Hemoglobin A1C 12 and 24 weeks after start medical nutritional therapy %/ blood test
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Secondary Outcome(s)
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Fasting plasma glucose 12 and 24 weeks after start medical nutritional therapy mg/dL blood test,Body weight 12 and 24 weeks after start medical nutritional therapy Kilograms,Low Density Lipoprotein-cholesterol 12 and 24 weeks after start medical nutritional therapy mg/dL blood test,Triglyceride 12 and 24 weeks after start medical nutritional therapy mg/dL blood test
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Secondary ID(s)
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MED-R2R-100
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Source(s) of Monetary Support
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Faculty of Medicine, Srinakharinwirot University
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Ethics review
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Status: Submitted, approved
Approval date:
Contact:
Ethics Committee of Research Faculty of Medicine, Srinakharinwirot University
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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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01/04/2015 |
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URL:
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