Effects of Dietary Fiber on Glucose Control in Subjects With Type 2 Diabetes Mellitus
1 other identifier
interventional
14
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 diabetes-mellitus-type-2
Started Feb 2014
Longer than P75 for phase_4 diabetes-mellitus-type-2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2018
CompletedFirst Posted
Study publicly available on registry
June 12, 2018
CompletedJune 12, 2018
June 1, 2018
1.7 years
May 17, 2018
June 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (5)
Microbiota composition change
the 4th week of study
Incretins (GIP)
the 4th week of study
Incretins (GLP-1)
the 4th week of study
Incretins (GLP-2)
the 4th week of study
Lipopolysaccharide (LPS)
the 4th week of study
Study Arms (1)
Agio arm
OTHERIt 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.
Interventions
6g before breakfast and 12g after dinner for first 28 days, and no medication for next 28 days for washout
Eligibility Criteria
You may qualify if:
- Among type 2 diabetic patients who visit Diabetes Center at Samsung Medical Center
- or more of following are required:
- 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
- waist circumference \> 90 cm in men and \> 80 cm in women
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samsung Medical Centerlead
- Bukwang Pharmaceutical, Co., Ltd.collaborator
- ChunLab, Inc.collaborator
Related Publications (7)
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.
PMID: 21977448RESULTKim 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.
PMID: 22247898RESULTSlavin 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.
PMID: 18953766RESULTBajorek 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.
PMID: 20959501RESULTBurcelin 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.
PMID: 21964884RESULTWalker 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.
PMID: 20686513RESULTMaslowski KM, Mackay CR. Diet, gut microbiota and immune responses. Nat Immunol. 2011 Jan;12(1):5-9. doi: 10.1038/ni0111-5.
PMID: 21169997RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Division of Endocrinology and Metabolism, Department of Internal Medicine
Study Record Dates
First Submitted
May 17, 2018
First Posted
June 12, 2018
Study Start
February 1, 2014
Primary Completion
October 1, 2015
Study Completion
May 31, 2018
Last Updated
June 12, 2018
Record last verified: 2018-06