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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Agiocur Pregranules


Participation Criteria
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Eligibility Criteria
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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: 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. 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Agio arm<br>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<br>* 6g before breakfast and 12g after dinner for first 28 days, and no medication for next 28 days for washout<br>* Other names: Agio gran.;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2, Metformin, Sulfonylurea Compounds, Dietary Fiber, Microbiota