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

NCT01496820 | Completed Phase 2 DMC

• 1 other identifier: KPB-HG-COS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Impaired Fasting Glucose, Newly-diagnosed Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Postprandial blood glucose(PPG)

  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 Outcomes (6)

• HbA1c

  Change from baseline in HbA1c at 12 weeks

• Insulin

  Change from baseline in insulin at 12 weeks

• glycemic AUC

  Change from baseline in glycemic AUC at 12 weeks

• Total cholesterol

  Change from baseline in Total cholesterol at 12 weeks

• Triglyceride

  Change from baseline in triglyceride at 12 weeks

Study Arms (2)

GO2KA1

EXPERIMENTAL

Dietary Supplement: GO2KA1

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

GO2KA1 DIETARY_SUPPLEMENT

GO2KA1(chitosan oligosaccharide)1500mg/day for 12weeks

GO2KA1

Placebo DIETARY_SUPPLEMENT

placebo 1500mg/day for 12weeks

Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University

Seoul, 120-749, South Korea

Location

MeSH Terms

Interventions

GO2KA1

Study Officials

• Jong-Ho Lee, PhD

  Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2011
• First Posted: December 21, 2011
• Study Start: July 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 17, 2013

Record last verified: 2013-07

Locations

KR (1)