Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03552991
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Collaborators:
Bukwang Pharmaceutical, Co., Ltd.
ChunLab, Inc.
Information provided by (Responsible Party):
MOON-KYU LEE, 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Agiocur Pregranules Phase 4

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Dietary Fiber on Glucose Control in Subjects With Type 2 Diabetes Mellitus
Actual Study Start Date : February 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
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.
Drug: Agiocur Pregranules
6g before breakfast and 12g after dinner for first 28 days, and no medication for next 28 days for washout
Other Name: Agio gran.




Primary Outcome Measures :
  1. Fasting glucose [ Time Frame: the 4th week of study ]
    By comparing the level of 4th week, compared to baseline

  2. Glycoalbumin [ Time Frame: the 4th week of study ]
    By comparing the level of 4th week, compared to baseline

  3. Insulinogenic index [ Time Frame: the 4th week of study ]
    By comparing the level of 4th week, compared to baseline

  4. Quantitative insulin sensitivity check index (QUICKI) [ Time Frame: 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 :
  1. Microbiota composition change [ Time Frame: the 4th week of study ]
    By comparing the level of 4th week, compared to baseline

  2. Incretins (GIP) [ Time Frame: the 4th week of study ]
    By comparing the level of 4th week, compared to baseline

  3. Incretins (GLP-1) [ Time Frame: the 4th week of study ]
    By comparing the level of 4th week, compared to baseline

  4. Incretins (GLP-2) [ Time Frame: the 4th week of study ]
    By comparing the level of 4th week, compared to baseline

  5. Lipopolysaccharide (LPS) [ Time Frame: the 4th week of study ]
    By comparing the level of 4th week, compared to baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications of Results:
Layout table for additonal information
Responsible Party: MOON-KYU LEE, Professor, Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03552991     History of Changes
Other Study ID Numbers: Agio study
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by MOON-KYU LEE, Samsung Medical Center:
Dietary Fiber
Microbiota
Diabetes Mellitus, Type 2
Metformin
Sulfonylurea Compounds
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases