A Randomized Trial to Assess the Efficacy and Safety of GO2KA1(Chitosan Oligosaccharide)on Blood Glucose Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01496820
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : July 17, 2013
Information provided by (Responsible Party):
Yonsei University

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 little effect on the blood glucose levels in hyperinsulinemia related diabetic models. Based on previous reports, high molecular weight chitosan either directly or indirectly related to insulin secretion in pancreas but has little effect on insulin resistance. In the present study, the effect of GO2KA1 (low molecular weight chitosan oligosaccharide) on blood glucose levels in Korean pre-diabetic adults, will be evaluated. The changes in postprandial blood glucose levels will be investigated in subjects with impaired fasting glucose or glucose tolerance.

Condition or disease Intervention/treatment Phase
Impaired Fasting Glucose, Newly-diagnosed Type 2 Diabetes Dietary Supplement: GO2KA1 Dietary Supplement: Placebo Phase 2 Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of GO2KA1(Chitosan Oligosaccharide) on Postprandial Blood Glucose in Korean Adults: a Clinical Randomized Trial
Study Start Date : July 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Experimental: GO2KA1 Dietary Supplement: GO2KA1
GO2KA1(chitosan oligosaccharide)1500mg/day for 12weeks

Placebo Comparator: Placebo Dietary Supplement: Placebo
placebo 1500mg/day for 12weeks

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. HbA1c [ Time Frame: Change from baseline in HbA1c at 12 weeks ]
  2. Insulin [ Time Frame: Change from baseline in insulin at 12 weeks ]
  3. glycemic AUC [ Time Frame: Change from baseline in glycemic AUC at 12 weeks ]
  4. Total cholesterol [ Time Frame: Change from baseline in Total cholesterol at 12 weeks ]
  5. Triglyceride [ Time Frame: Change from baseline in triglyceride at 12 weeks ]
  6. HDL-cholesterol [ Time Frame: Change from baseline in HDL-cholesterol at 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01496820

Korea, Republic of
Yonsei University
Seoul, Korea, Republic of, 120-749
Sponsors and Collaborators
Yonsei University
Principal Investigator: Jong-Ho Lee, PhD Yonsei University

Responsible Party: Yonsei University Identifier: NCT01496820     History of Changes
Other Study ID Numbers: KPB-HG-COS
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: July 17, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Chelating Agents
Sequestering Agents