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

Samsung Medical Center

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Agiocur Pregranules

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03552991

Agio study

Details and patient eligibility

About

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.

Full 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).

Enrollment: 14 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Agio arm

Other group

Description:

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.

Treatment:

Drug: Agiocur Pregranules