Status:
COMPLETED
A Randomized Trial to Assess the Efficacy and Safety of GO2KA1(Chitosan Oligosaccharide)on Blood Glucose Control
Lead Sponsor:
Yonsei University
Conditions:
Impaired Fasting Glucose, Newly-diagnosed Type 2 Diabetes
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The effects of chitosan on blood glucose levels have been contradicting. Hypoglycemic effects of high molecular weight chitosan are related to diabetic models with hypoinsulinemia but have shown littl...
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-diabet...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01496820
Start Date
July 1 2011
End Date
December 1 2012
Last Update
July 17 2013
Active Locations (1)
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1
Yonsei University
Seoul, South Korea, 120-749