Effects of Dietary Fiber on Glucose Control in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2018-05-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect of a commercial dietary fiber supplement on patients with type 2 diabetes mellitus, in the way of glucose control, insulin action in the body, and the gut microbiota (bacteria) abundance.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Collaborators: Bukwang Pharmaceutical, Co., Ltd.; ChunLab, Inc.

Criteria

Inclusion Criteria (all of the followings):

• Among type 2 diabetic patients who visit Diabetes Center at Samsung Medical Center

• 2 or more of following are required:

1. use of lipid-lowering drugs and / or triglyceride ≥ 150 mg/dL, high-density lipoprotein < 40 mg/dL in men and < 50 mg/dL in women

2. waist circumference > 90 cm in men and > 80 cm in women

3. antihypertensive medication and / or blood pressure ≥ 130/85 mmHg

• Hemoglobin A1c level 7.0 - 9.0% (6.5 - 9.0% in age 50-60 years old)

• Patients who are treated with combination therapy of sulfonylurea and metformin at least 6 months and in steady-glucose-controlled state.

Exclusion Criteria (at least one of the followings):

• Patients using insulin, alpha-glucosidase inhibitor, meglitinide, thiazolidinedione, or incretin agent (both oral or injectables)

• Recently diagnosed (within 6 months) acute diabetic complication such as diabetic ketoacidosis and hyperosmolar hyperglycemic state

• Clinically significant cardiovascular disease

• Patients treated with oral or intravenous antibiotics last 12 months

• Patients who took fiber supplements last 6 months

• Fasting serum c-peptide level < 1 ng/mL

• Duration of type 2 diabetes > 10 years