Clinical trial NCT03552991: Effects of Dietary Fiber on Glucose Control in Subjects With Type 2 Diabetes Mellitus
Official title: Effects of Dietary Fiber on Glucose Control in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Dietary Fiber
Microbiota
Diabetes Mellitus, Type 2
Metformin
Sulfonylurea Compounds
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Bukwang Pharmaceutical, Co., Ltd.
name: ChunLab, Inc.
First posted: 2018-06-12
Enrollment: 14
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Eligibility 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

Primary outcomes:
measure: Fasting glucose
timeFrame: the 4th week of study
measure: Glycoalbumin
timeFrame: the 4th week of study
measure: Insulinogenic index
timeFrame: the 4th week of study
measure: Quantitative insulin sensitivity check index (QUICKI)
timeFrame: the 4th week of study
Secondary outcomes:
measure: Microbiota composition change
timeFrame: the 4th week of study
measure: Incretins (GIP)
timeFrame: the 4th week of study
measure: Incretins (GLP-1)
timeFrame: the 4th week of study
measure: Incretins (GLP-2)
timeFrame: the 4th week of study
measure: Lipopolysaccharide (LPS)
timeFrame: the 4th week of study
Other outcomes:
Locations:
Study officials:
References:
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.
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.
citation: 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.
citation: 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.
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.
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. ISME J. 2011 Feb;5(2):220-30. doi: 10.1038/ismej.2010.118. Epub 2010 Aug 5.
citation: Maslowski KM, Mackay CR. Diet, gut microbiota and immune responses. Nat Immunol. 2011 Jan;12(1):5-9. doi: 10.1038/ni0111-5.