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

This study is currently recruiting participants.
Verified December 2011 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01496820
First received: December 18, 2011
Last updated: December 20, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention Phase
Subjects With Impaired Glucose Tolerance or Impaired Fasting Glucose
 Dietary Supplement: GO2KA1
Dietary Supplement: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effect of GO2KA1(Chitosan Oligosaccharide) on Postprandial Blood Glucose in Korean Adults: a Clinical Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Postprandial blood glucose(PPG) [ Time Frame: Change from baseline in PPG at 12 weeks ] [ Designated as safety issue: Yes ]
    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:
  • HbA1c [ Time Frame: Change from baseline in HbA1c at 12 weeks ] [ Designated as safety issue: Yes ]
  • Insulin [ Time Frame: Change from baseline in insulin at 12 weeks ] [ Designated as safety issue: Yes ]
  • glycemic AUC [ Time Frame: Change from baseline in glycemic AUC at 12 weeks ] [ Designated as safety issue: Yes ]
  • Total cholesterol [ Time Frame: Change from baseline in Total cholesterol at 12 weeks ] [ Designated as safety issue: Yes ]
  • Triglyceride [ Time Frame: Change from baseline in triglyceride at 12 weeks ] [ Designated as safety issue: Yes ]
  • HDL-cholesterol [ Time Frame: Change from baseline in HDL-cholesterol at 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GO2KA1 Dietary Supplement: GO2KA1
GO2KA1(chitosan oligosaccharide)1500mg/day for 12weeks
Placebo Comparator: Placebo Dietary Supplement: Placebo
placebo 1500mg/day for 12weeks

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496820

Contacts
Contact: Jong-Ho Lee, PhD 82-2-2123-3122 jhleeb@yonsei.ac.kr
Contact: Jeong-Hyun Kwak, PhD 82-2-2123-8158 hyun4615@yonsei.ac.kr

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

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01496820     History of Changes
Other Study ID Numbers: KPB-HG-COS
Study First Received: December 18, 2011
Last Updated: December 20, 2011
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Chitosan
Chelating Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents

ClinicalTrials.gov processed this record on May 21, 2013