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Diabetes Mellitus, Type 2Phase 4NCT03552991

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

A Phase 4 study testing Agiocur Pregranules in people with Diabetes Mellitus, Type 2, run by Samsung Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Agiocur Pregranules
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
No sites listed yet
Study dates
Feb 2014to 31 May 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

About this study

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.

Read the 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).

Being tested
Agiocur Pregranules
Keywords
Dietary Fiber, Microbiota, Diabetes Mellitus, Type 2, Metformin, Sulfonylurea Compounds
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Agiocur PregranulesDrug

    Also called Agio gran.

    6g before breakfast and 12g after dinner for first 28 days, and no medication for next 28 days for washout

Study groups in NCT03552991
Study groupRoleWhat they receive
Agio armOtherIt 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.
Receives: Drug: Agiocur Pregranules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fasting glucose

    By comparing the level of 4th week, compared to baseline

    Measured: the 4th week of study

  2. Glycoalbumin

    By comparing the level of 4th week, compared to baseline

    Measured: the 4th week of study

  3. Insulinogenic index

    By comparing the level of 4th week, compared to baseline

    Measured: the 4th week of study

  4. 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.

    Measured: the 4th week of study

Secondary outcomes (5)

  1. Microbiota composition change

    By comparing the level of 4th week, compared to baseline

    Measured: the 4th week of study

  2. Incretins (GIP)

    By comparing the level of 4th week, compared to baseline

    Measured: the 4th week of study

  3. Incretins (GLP-1)

    By comparing the level of 4th week, compared to baseline

    Measured: the 4th week of study

  4. Incretins (GLP-2)

    By comparing the level of 4th week, compared to baseline

    Measured: the 4th week of study

  5. Lipopolysaccharide (LPS)

    By comparing the level of 4th week, compared to baseline

    Measured: the 4th week of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2018
  2. Study startFeb 2014
  3. Primary completionOct 2015
  4. Study completion31 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03552991
Sponsor's protocol ID
Agio study
Status last verified
Jun 2018
First submitted
17 May 2018
Last updated
12 Jun 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 21977448

  • 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.

    PubMed 22247898

  • 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.

    PubMed 18953766

  • 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.

    PubMed 20959501

  • 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.

    PubMed 21964884

  • 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.

    PubMed 20686513

  • Maslowski KM, Mackay CR. Diet, gut microbiota and immune responses. Nat Immunol. 2011 Jan;12(1):5-9. doi: 10.1038/ni0111-5.

    PubMed 21169997

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Agiocur Pregranules in people with Diabetes Mellitus, Type 2, run by Samsung Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting glucose (time frame: the 4th week of study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03552991, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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