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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Agiocur Pregranules

Detailed Description

Fiber supplements such as psyllium are known to be beneficial to glycemic control in patients with type 2 diabetes mellitus (T2DM). Gut microbiota has a role in regulating host energy metabolism and systemic inflammation by several pathways such as short-chain fatty acid production, fasting-induced adipose factor expression, endocannabinoid system, and gut epithelial permeability. As dietary components can influence the composition of the microbiota, we hypothesized that fiber supplements could modify gut microbiota and consequently affect glycemic control and inflammatory condition in patients with T2DM.

The primary outcome was to assess the effect of fiber on glucose control (by comparing fasting glucose and glycoalbumin), insulin secretion and sensitivity. Secondary outcomes were the changes abundance of microbiota, incretins, and lipopolysaccharide (LPS).

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Agio arm; It is a pilot study based on the proof-of-concept that dietary fiber helps glucose control in patients with type 2 diabetes. As a single-arm study, 'Agiocur Pregranules' (dietary fiber) is administered for 28 days and stopped for next 28 days, in patients with type 2 diabetes.	Drug: Agiocur Pregranules; 6g before breakfast and 12g after dinner for first 28 days, and no medication for next 28 days for washout; Other Names: Agio gran.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting glucose	By comparing the level of 4th week, compared to baseline	the 4th week of study
Glycoalbumin	By comparing the level of 4th week, compared to baseline	the 4th week of study
Insulinogenic index	By comparing the level of 4th week, compared to baseline	the 4th week of study
Quantitative insulin sensitivity check index (QUICKI)	By comparing the level of 4th week, compared to baseline. QUICKI is derived from fasting blood glucose and insulin level, reflecting insulin sensitivity.	the 4th week of study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiota composition change	By comparing the level of 4th week, compared to baseline	the 4th week of study
Incretins (GIP)	By comparing the level of 4th week, compared to baseline	the 4th week of study
Incretins (GLP-1)	By comparing the level of 4th week, compared to baseline	the 4th week of study
Incretins (GLP-2)	By comparing the level of 4th week, compared to baseline	the 4th week of study
Lipopolysaccharide (LPS)	By comparing the level of 4th week, compared to baseline	the 4th week of study

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Kim DJ. The epidemiology of diabetes in Korea. Diabetes Metab J. 2011 Aug;35(4):303-8. doi: 10.4093/dmj.2011.35.4.303. Epub 2011 Aug 31.
• Kim JH, Kim DJ, Jang HC, Choi SH. Epidemiology of micro- and macrovascular complications of type 2 diabetes in Korea. Diabetes Metab J. 2011 Dec;35(6):571-7. doi: 10.4093/dmj.2011.35.6.571. Epub 2011 Dec 26.
• Slavin JL. Position of the American Dietetic Association: health implications of dietary fiber. J Am Diet Assoc. 2008 Oct;108(10):1716-31. doi: 10.1016/j.jada.2008.08.007. Erratum In: J Am Diet Assoc. 2009 Feb;109(2):350.
• Bajorek SA, Morello CM. Effects of dietary fiber and low glycemic index diet on glucose control in subjects with type 2 diabetes mellitus. Ann Pharmacother. 2010 Nov;44(11):1786-92. doi: 10.1345/aph.1P347. Epub 2010 Oct 19.
• Burcelin R, Serino M, Chabo C, Blasco-Baque V, Amar J. Gut microbiota and diabetes: from pathogenesis to therapeutic perspective. Acta Diabetol. 2011 Dec;48(4):257-273. doi: 10.1007/s00592-011-0333-6. Epub 2011 Oct 2.
• Walker AW, Ince J, Duncan SH, Webster LM, Holtrop G, Ze X, Brown D, Stares MD, Scott P, Bergerat A, Louis P, McIntosh F, Johnstone AM, Lobley GE, Parkhill J, Flint HJ. Dominant and diet-responsive groups of bacteria within the human colonic microbiota. ISME J. 2011 Feb;5(2):220-30. doi: 10.1038/ismej.2010.118. Epub 2010 Aug 5.
• Maslowski KM, Mackay CR. Diet, gut microbiota and immune responses. Nat Immunol. 2011 Jan;12(1):5-9. doi: 10.1038/ni0111-5.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: June 10, 2018
• First Posted (Actual): June 12, 2018

Study Record Updates

• Last Update Posted (Actual): June 12, 2018
• Last Update Submitted That Met QC Criteria: June 10, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Microbiota; Metformin; Diabetes Mellitus, Type 2; Dietary Fiber; Sulfonylurea Compounds
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Agio study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No