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

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.

Conditions

• Diabetes Mellitus Type 2

Interventions

DIETARY_SUPPLEMENT

Probiotics

Administration of probiotics daily for 26 weeks and compared to placebo

DIETARY_SUPPLEMENT

Placebo

Administration of placebo daily for 26 weeks and compared to probiotics group

Sponsors & Collaborators

• Warwick Medical School

  collaborator OTHER

• Winclove Bio Industries BV

  collaborator INDUSTRY

• King Saud University

  lead OTHER

Principal Investigators

• Nasser Al-Daghri, PhD · King Saud University

• Majed Alokail, PhD · King Saud University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

SINGLE_GROUP

Eligibility

Min Age

20 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-10-31

Primary Completion

2017-02-28

Completion

2017-02-28

Countries

• Saudi Arabia

Study Locations