Study to Explore the Effects of Probiotics on Endotoxin Levels in Type 2 Diabetes Mellitus Patients

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. Identifier: NCT01765517
Recruitment Status : Unknown
Verified August 2016 by Nasser Al-Daghri, King Saud University.
Recruitment status was:  Active, not recruiting
First Posted : January 10, 2013
Last Update Posted : August 31, 2016
Warwick Medical School
Winclove Bio Industries BV
Information provided by (Responsible Party):
Nasser Al-Daghri, King Saud University

Brief Summary:
Probiotics, which are believed to be health promoting live microorganisms, have been reported to influence circulating endotoxin levels. Ingestion of the live cultures may alter gut mircobiota in a beneficial manner to reduce inflammation; although their mechanism and influence to reduce inflammation in T2DM is not established for this disease state. Therefore, the aim of this study is to (1) characterize the beneficial effects of probiotics on circulating endotoxin levels and other biomarkers related to systemic low-grade inflammation in patients with T2DM; (2) Compare circulating endotoxin levels and inflammatory cytokine levels between patients treated with probiotics or placebo to examine the beneficial effects of probiotics on reducing the inflammatory status, through assessment of systemic markers (adipokines, endotoxin, cytokines); (3) to examine the effects of probiotics on gut microflora in order to understand the mechanism for such change in inflammatory status. To achieve this, 120 consenting adult Saudis, naïve or newly diagnosed T2DM patients without co-morbidities, will be enrolled in this clinical trial and randomized to receive twice-daily placebo or probiotics for 26 weeks in a double-blind manner. Glycemic inflammatory markers will be measured and fecal samples analysed, interventions will be done at baseline, 4, 8, 12 and 26 weeks. It is envisaged that probiotics will induce beneficial changes in gut mircobiota, reduce the systemic inflammatory state through altering systemic endotoxin levels and, as such, reduce the systemic inflammatory response observed in T2DM subjects. This will have a fundamental impact on how we should treat the inflammatory component of T2DM, particularly once the results are verified in a larger cohort of patients, as this could have very dramatic effects on how we treat patients with T2DM. Reducing the pathogenesis of T2DM by dampening the inflammatory response, which may also impact on insulin resistance status and health of the individual, will have clear benefits. This could have profound effects on preventative T2DM management, as well as current T2DM care without excessive cost for the wider Saudi health economy.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Dietary Supplement: Probiotics Dietary Supplement: Placebo Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: A 26-week, Randomized, Double-blind, Placebo-controlled Study to Explore the Effects of Probiotics on Endotoxin Levels in Patients With Type 2 Diabetes Mellitus
Study Start Date : October 2013
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Probiotics
Dietary Supplement: Probiotics
Administration of probiotics daily for 26 weeks and compared to placebo
Other Name: Ecologic Metabolic

Placebo Comparator: Placebo
Dietary Supplement: Placebo
Administration of placebo daily for 26 weeks and compared to probiotics group

Primary Outcome Measures :
  1. effects of probiotics on endotoxin levels in patients with T2DM [ Time Frame: 1 year ]
    Exploration of baseline characteristics and determination of associations between nutritional habits, gut flora and levels of endotoxin/inflammatory markers at baseline and subsequent follow ups

Secondary Outcome Measures :
  1. effects of probiotics on gut microflora [ Time Frame: 1 year ]
    Determine changes from baseline in the amount of probiotics, all anaerobic bacteria and short-chain fatty acids (e.g., propionate and butyrate) present in fecal samples.

Other Outcome Measures:
  1. Effects of probiotics on insulin resistance [ Time Frame: 1 year ]
    Determine changes from baseline in serum levels of glucose, HbA1C, insulin and C-peptide

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Stable and well controlled T2DM (HbA1c < 7.5% and no change in oral antidiabetic medications during the last 6 months)
  • Age 20-75 years
  • Provision of written informed consent

Exclusion Criteria:

  • Chronic gastrointestinal disease (except IBS)
  • Systemic antibiotics within 6 weeks before inclusion
  • Use of probiotics within 3 months before inclusion (Appendix A lists products currently marketed internationally and available to purchase in Saudi Arabia)
  • Regular intake of insulin or insulin analogs, antibiotics or probiotics, antacids, H2-receptor blockers, proton pump inhibiters, loperamide, cholestryramine, ω3 supplements, fibrates, corticosteroids or sex steroids
  • Daily alcohol consumption > 30 g
  • Significant immunodeficiency
  • Known cardiac valvular disease
  • Breast-feeding or pregnant
  • Non-Arab ethnicity
  • Participation in another clinical trial within the last 6 months
  • Legal incapability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01765517

Saudi Arabia
Biomarkers Research Program, King Saud university
Riyadh, Saudi Arabia, 11451
Sponsors and Collaborators
King Saud University
Warwick Medical School
Winclove Bio Industries BV
Study Chair: Nasser Al-Daghri, PhD King Saud University
Principal Investigator: Majed Alokail, PhD King Saud University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Nasser Al-Daghri, Professor, King Saud University Identifier: NCT01765517     History of Changes
Other Study ID Numbers: 11-MED2114-02
NPST_Alokail ( Other Grant/Funding Number: NPST )
First Posted: January 10, 2013    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016

Keywords provided by Nasser Al-Daghri, King Saud University:
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases