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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Agiocur Pregranules

• Registration Number: NCT03552991
• Lead Sponsor: Samsung Medical Center

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).

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2015-10
• Study First Submitted: 2018-05-17
• Study Completion: 2018-05-31
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-10
• Last Update Submitted: 2018-06-10
• Study First Posted: 2018-06-12
• Last Update Posted: 2018-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Agio arm	Agiocur Pregranules	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.

Primary Outcome Measures

Name	Time	Method
Glycoalbumin	the 4th week of study	By comparing the level of 4th week, compared to baseline
Insulinogenic index	the 4th week of study	By comparing the level of 4th week, compared to baseline
Fasting glucose	the 4th week of study	By comparing the level of 4th week, compared to baseline
Quantitative insulin sensitivity check index (QUICKI)	the 4th week of study	By comparing the level of 4th week, compared to baseline. QUICKI is derived from fasting blood glucose and insulin level, reflecting insulin sensitivity.

Secondary Outcome Measures

Name	Time	Method
Lipopolysaccharide (LPS)	the 4th week of study	By comparing the level of 4th week, compared to baseline
Microbiota composition change	the 4th week of study	By comparing the level of 4th week, compared to baseline
Incretins (GIP)	the 4th week of study	By comparing the level of 4th week, compared to baseline
Incretins (GLP-1)	the 4th week of study	By comparing the level of 4th week, compared to baseline
Incretins (GLP-2)	the 4th week of study	By comparing the level of 4th week, compared to baseline