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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by King Saud University
Sponsor:
Collaborators:
Warwick Medical School
Winclove Bio Industries BV
Information provided by (Responsible Party):
Nasser Al-Daghri, King Saud University
ClinicalTrials.gov Identifier:
NCT01765517
First received: January 1, 2013
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

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 Intervention
Diabetes Mellitus Type 2
Dietary Supplement: Probiotics
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by King Saud University:

Primary Outcome Measures:
  • effects of probiotics on endotoxin levels in patients with T2DM [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • effects of probiotics on gut microflora [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Effects of probiotics on insulin resistance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Determine changes from baseline in serum levels of glucose, HbA1C, insulin and C-peptide


Estimated Enrollment: 120
Study Start Date: October 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotics
Probitoics
Dietary Supplement: Probiotics
Administration of probiotics daily for 26 weeks and compared to placebo
Other Name: Ecologic Metabolic
Placebo Comparator: Placebo
Placebo
Dietary Supplement: Placebo
Administration of placebo daily for 26 weeks and compared to probiotics group

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765517

Contacts
Contact: Nasser M Al-Daghri, PhD 0096614675939 ndaghri@ksu.edu.sa
Contact: Shaun Louie B Sabico, MD 00966534689404 s.l.sabico@warwick.ac.uk

Locations
Saudi Arabia
Biomarkers Research Program, King Saud university Not yet recruiting
Riyadh, Saudi Arabia, 11451
Contact: Nasser Al-Daghri, PhD    00966534689404    ndaghri@ksu.edu.sa   
Contact: Shaun Sabico, MD    0096614675939    s.l.sabico@warwick.ac.uk   
Sub-Investigator: Shaun Sabico, MD         
Sponsors and Collaborators
King Saud University
Warwick Medical School
Winclove Bio Industries BV
Investigators
Study Chair: Nasser Al-Daghri, PhD King Saud University
Principal Investigator: Majed Alokail, PhD King Saud University
  More Information

No publications provided by King Saud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nasser Al-Daghri, Professor, King Saud University
ClinicalTrials.gov Identifier: NCT01765517     History of Changes
Other Study ID Numbers: 11-MED2114-02, NPST_Alokail
Study First Received: January 1, 2013
Last Updated: July 23, 2013
Health Authority: Saudi Arabia: Ministry of Health

Keywords provided by King Saud University:
Diabetes Mellitus

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

ClinicalTrials.gov processed this record on September 18, 2014