Status Approved
First Submitted Date
2016/01/11
Registered Date
2016/01/14
Last Updated Date
2016/01/14
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0001771 |
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Unique Protocol ID | KNUH 2012-03-032 |
Public/Brief Title | Evaluation of clinical effects and persistent organic pollutants (POPs)-related mechanisms of vegan diet among patients with diabetes |
Scientific Title | Evaluation of clinical effects and POPs-related mechanisms of vegan diet among Patients with Type 2 Diabetes |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | |
Registered at Other Registry | No |
Healthcare Benefit Approval Status |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | KNUH 2012-03-032 |
Approval Date | 2012-04-03 |
Institutional Review Board Name | Institutional Review Board of Kyungpook National University Hospital |
Institutional Review Board Address | |
Institutional Review Board Telephone | |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Duk-Hee Lee |
Title | M.D., Ph.D. |
Telephone | +82-53-420-4866 |
Affiliation | Kyungpook National University Hospital |
Address | 130 Dongdeok-ro, Jung-gu, Daegu, Korea |
Contact Person for Public Queries | |
Name | Yu-Mi Lee |
Title | M.D. |
Telephone | +82-53-420-4862 |
Affiliation | Kyungpook National University |
Address | 680 Gukchaebosang-ro, Jung-gu, Daegu, Korea |
Contact Person for Updating Information | |
Name | Yu-Mi Lee |
Title | M.D. |
Telephone | +82-53-420-4862 |
Affiliation | Kyungpook National University |
Address | 680 Gukchaebosang-ro, Jung-gu, Daegu, Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2012-04-03 Actual | |
Target Number of Participant | 106 | |
Primary Completion Date | 2012-10-25 , Actual | |
Study Completion Date | 2013-01-29 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Kyungpook National University | |
Recruitment Status | Completed | |
Date of First Enrollment | 2012-04-03 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Ministry of Health & Welfare |
Organization Type | Government |
Project ID | A111716 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Kyungpook National University |
Organization Type | University |
7. Study Summary
Lay Summary | Recent some studies have suggested that vegetarian and vegan diet have health benefits for a control and management of type 2 diabetes. We tried to evaluate a glycemic control effects of vegan diet and conventionally recommended diabetic diet by using randomized clinical trial. Participants with type 2 diabetes will be randomly assigned to a vegan diet group or a conventional diet group recommended by the Korean Diabetes Association 2011 for 12 weeks. · Primary endpoint: a change of HbA1c during 12 weeks in two groups · Secondary endpoint: a change of BMI, waist circumference, blood pressure, and lipid control during 12 weeks in two groups |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Prevention |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Open |
Allocation | RCT |
Intervention Type | Others (Diet) |
Intervention Description | a 12-week Randomized Clinical Trial participants: previously diagnosed with type 2 diabetes 1) Experimental group: vegan diet consisted of whole grains, vegetables, fruit, and legumes 2) Control group: conventional diet followed treatment guidelines for diabetes recommended by Korean Diabetic Association (KDA) 2011 |
Number of Arms | 2 |
Arm 1 |
Arm Label vegan diet group |
Target Number of Participant 53 |
|
Arm Type Experimental |
|
Arm Description Participants were asked to follow vegan diet consisted of whole grains, vegetables, fruit, and legumes: 1) ingest unpolished rice; 2) avoid polished rice; 3) avoid processed food made of rice flour or wheat flour; 4) avoid all animal food products (i.e., meat, poultry, fish, daily goods, and eggs); 5) recommended to favor low-glycemic index foods (e.g., legumes, legumes-based food, green vegetables, and seaweed). Participants were mainly educated the diet to should avoid eat rather than should eat. Amount and frequency of food consumption, energy intake and portion sizes were not restricted. |
|
Arm 2 |
Arm Label conventional diet group followed treatment guidelines for diabetes recommended by Korean Diabetic Association (KDA) |
Target Number of Participant 53 |
|
Arm Type Active comparator |
|
Arm Description The conventional diet followe treatment guidelines for diabetes recommended by Korean Diabetic Association (KDA) 2011. Participants asked to 1) restrict individualized daily energy intake based on body weight, physical activity, a need for weight control and compliance; 2) 50-60% carbohydrate, 15-20% protein if renal function is normal, < 25% fat, <7% saturated fat, minimize trans-fat intake, and cholesterol ≤200 mg/day |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (E00-E90)Endocrine, nutritional and metabolic diseases (E11.9)Type 2 diabetes mellitus, without complications |
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Rare Disease | No |
Inclusion Criteria |
Gender Female |
Age 30Year~70Year |
|
Description · women aged from 30 to 70 years old; · use of hypoglycemic medications for ≥ 6 months · 6.5% ≤ glycosylated hemoglobin (HbA1c) ≤ 11.0% |
|
Exclusion Criteria |
· increased dose of hypoglycemic medication or add a new drug during recent 2 months · smoker or drinker · current vegetarian · pregnancy · severe complications (e.g.,chronic renal failure) |
Healthy Volunteers |
10. Outcome Measure(s)
Type of Primary Outcome | clinical-equivalence | |
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Primary Outcome(s) 1 | ||
Outcome | change of HbA1c levels |
|
Timepoint | after 12 weeks |
|
Secondary Outcome(s) 1 | ||
Outcome | change of body mass index |
|
Timepoint | after 12 weeks |
|
Secondary Outcome(s) 2 | ||
Outcome | change of waist circumference |
|
Timepoint | after 12 weeks |
|
Secondary Outcome(s) 3 | ||
Outcome | change of triglycerides levels |
|
Timepoint | after 12 weeks |
|
Secondary Outcome(s) 4 | ||
Outcome | change of LDL-choleaterol levels |
|
Timepoint | after 12 weeks |
|
Secondary Outcome(s) 5 | ||
Outcome | change of HDL-choleaterol levels |
|
Timepoint | after 12 weeks |
|
Secondary Outcome(s) 6 | ||
Outcome | change of fasting blood glucose levels |
|
Timepoint | after 12 weeks |
|
Secondary Outcome(s) 7 | ||
Outcome | change of systolic blood pressure |
|
Timepoint | after 12 weeks |
|
Secondary Outcome(s) 8 | ||
Outcome | change of diastolic blood pressure |
|
Timepoint | after 12 weeks |
11. Study Results and Publication
Result Registered |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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