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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03552991
• Other study ID #: Agio study
• Status: Completed
• Phase: Phase 4
• Start date: February 2014
• Est. completion date: May 31, 2018

Study information

• Verified date: June 2018
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 31, 2018
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Agiocur Pregranules
6g before breakfast and 12g after dinner for first 28 days, and no medication for next 28 days for washout

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Samsung Medical Center	Bukwang Pharmaceutical, Co., Ltd., ChunLab, Inc.

References & Publications (7)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Maslowski KM, Mackay CR. Diet, gut microbiota and immune responses. Nat Immunol. 2011 Jan;12(1):5-9. doi: 10.1038/ni0111-5. — View Citation

Slavin JL. Position of the American Dietetic Association: health implications of dietary fiber. J Am Diet Assoc. 2008 Oct;108(10):1716-31. Erratum in: J Am Diet Assoc. 2009 Feb;109(2):350. — View Citation

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. IS — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting glucose	By comparing the level of 4th week, compared to baseline	the 4th week of study
Primary	Glycoalbumin	By comparing the level of 4th week, compared to baseline	the 4th week of study
Primary	Insulinogenic index	By comparing the level of 4th week, compared to baseline	the 4th week of study
Primary	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	Microbiota composition change	By comparing the level of 4th week, compared to baseline	the 4th week of study
Secondary	Incretins (GIP)	By comparing the level of 4th week, compared to baseline	the 4th week of study
Secondary	Incretins (GLP-1)	By comparing the level of 4th week, compared to baseline	the 4th week of study
Secondary	Incretins (GLP-2)	By comparing the level of 4th week, compared to baseline	the 4th week of study
Secondary	Lipopolysaccharide (LPS)	By comparing the level of 4th week, compared to baseline	the 4th week of study