- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01496820
A Randomized Trial to Assess the Efficacy and Safety of GO2KA1(Chitosan Oligosaccharide)on Blood Glucose Control
Effect of GO2KA1(Chitosan Oligosaccharide) on Postprandial Blood Glucose in Korean Adults: a Clinical Randomized Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
In the detailed description we believe that it will be wise to discuss about the long-term study of the effect of GO2KA1(Chitosan oligosaccharide: oligosaccharides derived from chitosan) on pre-diabetic individuals (in addition to the postprandial blood glucose levels). In the present study, we will investigate the effects of GO2KA1 on the level of postprandial blood glucose in adult Koreans with impaired fasting glucose or impaired glucose tolerance. Postprandial blood glucose levels will be tested for 2 hours at every 30 min interval after 75g-OGTT and the experimental group will be pre-fed with 500 mg of GO2KA1. Primary outcomes will be included change in HbA1c, insulin, glycemic AUC, and lipids(total cholesterol, triglyceride, and HDL).
This clinical study will be conducted with 60 subjects after explanation and accommodation about experimental protocols and model. To test under same condition, smoking and drinking water will be completely prohibit from 1 hour before and during the experiment. At first day, control experiment will be conducted without oral take of GO2KA1 or placebo.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
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Seoul, Korea, Republic of, 120-749
- Yonsei University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- males and females 20-75 years old
- impaired fasting glucose (FPG 100~125 mg/dL) or impaired glucose tolerance (PPG-2h 140~200 mg/dL)
- able to give informed consent
Exclusion Criteria:
- having received a diagnosis of diabetes or receiving treatment for diabetes
- having a history of ischemic heart disease, stroke, liver cirrhosis, chronic pancreatitis, pituitary disease, thyroid disease, adrenal gland disease, mental illness, gastrectomy, or advanced malignant tumor
- receiving corticosteroid or thyroid hormone medication
- being judged by the responsible physician of the local study center as unfit to participate in the study
- abnormal liver or kidney function tests (ALT or AST > 2 times the upper limit of normal
- elevated creatinine, males > 125 umol/L, females > 110 umol/L)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
placebo 1500mg/day for 12weeks
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Experimental: GO2KA1
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GO2KA1(chitosan oligosaccharide)1500mg/day for 12weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial blood glucose(PPG)
Time Frame: Change from baseline in PPG at 12 weeks
|
Primary outcome will be tested for 2 hours at every 30 min interval after 75g-OGTT and the experimental group will be pre-fed with 500 mg of GO2KA1.
|
Change from baseline in PPG at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1c
Time Frame: Change from baseline in HbA1c at 12 weeks
|
Change from baseline in HbA1c at 12 weeks
|
Insulin
Time Frame: Change from baseline in insulin at 12 weeks
|
Change from baseline in insulin at 12 weeks
|
glycemic AUC
Time Frame: Change from baseline in glycemic AUC at 12 weeks
|
Change from baseline in glycemic AUC at 12 weeks
|
Total cholesterol
Time Frame: Change from baseline in Total cholesterol at 12 weeks
|
Change from baseline in Total cholesterol at 12 weeks
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Triglyceride
Time Frame: Change from baseline in triglyceride at 12 weeks
|
Change from baseline in triglyceride at 12 weeks
|
HDL-cholesterol
Time Frame: Change from baseline in HDL-cholesterol at 12 weeks
|
Change from baseline in HDL-cholesterol at 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jong-Ho Lee, PhD, Yonsei University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KPB-HG-COS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on GO2KA1
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