Effects of Dietary Fiber on Glucose Control in Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT03552991
Last Updated: 2018-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
14 participants
INTERVENTIONAL
2014-02-28
2018-05-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Agiocur Pregranules
6g before breakfast and 12g after dinner for first 28 days, and no medication for next 28 days for washout
Interventions
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Agiocur Pregranules
6g before breakfast and 12g after dinner for first 28 days, and no medication for next 28 days for washout
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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Bukwang Pharmaceutical, Co., Ltd.
INDUSTRY
ChunLab, Inc.
UNKNOWN
Samsung Medical Center
OTHER
Responsible Party
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MOON-KYU LEE
Professor, Division of Endocrinology and Metabolism, Department of Internal Medicine
References
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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.
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.
Other Identifiers
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Agio study
Identifier Type: -
Identifier Source: org_study_id
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