Probiotics as a Novel Approach to Modulate Gut Hormone Secretion and Risk Factors of Type 2 Diabetes and Complications

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by German Diabetes Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Heinrich-Heine University, Duesseldorf
Information provided by:
German Diabetes Center
ClinicalTrials.gov Identifier:
NCT01250106
First received: November 24, 2010
Last updated: July 28, 2011
Last verified: July 2011
  Purpose

The investigators aim to test the hypothesis that Lactobacillus Reuteri-enriched microbiota improves insulin sensitivity and glucose tolerance in obese healthy and obese type 2 diabetes patients by improving gut hormone secretion and compare these findings to healthy lean subjects.


Condition Intervention Phase
Obesity
Type 2 Diabetes
Dietary Supplement: Lactobacillus reuteri
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase I Study of Probiotics as a Novel Approach to Modulate Gut Hormone Secretion and Risk Factors of Type 2 Diabetes and Complications

Resource links provided by NLM:


Further study details as provided by German Diabetes Center:

Primary Outcome Measures:
  • Insulin resistance [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • gut hormones (GLP-1, GLP-2, GIP) [ Time Frame: 8 and 10 weeks ] [ Designated as safety issue: No ]
  • insulin secretion [ Time Frame: 8 and 10 weeks ] [ Designated as safety issue: No ]
  • measurement of cytokines to define the immune status [ Time Frame: 8 and 10 weeks ] [ Designated as safety issue: No ]
    measurement and analysis of proinflammatory cytokines (Interleukin (IL)-6, tumor necrosis factor (TNF)-α, IL-1ß, Macropahge inflammatory protein (MIP)-1ß) and regulatory cytokines (IL-10, transforming growth factor (TGF)-ß, IL1ra) from peripheral blood samples collected during this trial

  • body weight [ Time Frame: 8 and 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotic capsule Dietary Supplement: Lactobacillus reuteri
twice daily
Placebo Comparator: placebo capsule Dietary Supplement: Lactobacillus reuteri
twice daily

Detailed Description:

Prediabetes and diabetes are accompanied by insufficient gut hormone release, insulin resistance, insufficient insulin secretory capacity and low grade systemic inflammation. Results of recent animal experiments suggest that ingestion of probiotics not only influences gut microbiota composition and intestinal permeability but also secretion of GLP-2 as well as insulin resistance, components of metabolic syndrome and diabetes development. GLP-2 secretion has been suggested to be a key mediator of probiotic effects mediating decreased intestine permeability through binding to intestinal GLP2 receptor in animal studies. Insulinotropic GLP-1, which is reduced in patients with type 2 diabetes, has also been described to be influenced by gut microbiota composition. We aim to test the hypothesis that Lactobacillus Reuteri-enriched microbiota improves insulin sensitivity and glucose tolerance in obese healthy and obese type 2 diabetes patients by improving gut hormone secretion. In a prospective, double-blinded, placebo controlled randomized 10 weeks trial we aim to investigate metabolic and immunological changes related to modified gut microbiota by analysing (1) gut hormone secretion, (2) insulin sensitivity and glucose tolerance, and (3) systemic LPS concentrations and immune status.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Obese subjects: age 40 - 65 years, obesity (BMI 30-45 kg/m2), non-smoking, absence of gastrointestinal disease, willingness to abstain from intake of fermented milk products over a study period of 8 weeks.
  • Healthy control subjects: non-obese (BMI 19-25 kg/m2), non-diabetic subjects, matched for age and sex, non-smoking, absence of gastrointestinal disease, willingness to abstain from intake of fermented milk products over a study period of 8 weeks.

Exclusion Criteria:

  • pregnancy, cancer, chronic diseases, antibiotic therapy, competitive athletes.
  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: NCT01250106

Contacts
Contact: Nanette C Schloot, MD +49 211 3382 ext 665 schloot@ddz.uni-duesseldorf.de
Contact: Marie-Christine Simon, Dipl. oecotroph. +49 211 3382 ext 229 marie-christine.simon@ddz.uni-duesseldorf.de

Locations
Germany
German Diabetes Center Recruiting
Düsseldorf, Duesseldorf, Germany, 40225
Contact: Nanette C Schloot, MD    +49 211 3382 ext 665    schloot@ddz.uni-duesseldorf.de   
Contact: Marie-Christine Simon, Dipl. Oecotroph    +49 211 3382 ext 229    marie-christine.simon@ddz.uni-duesseldorf.de   
Principal Investigator: Nanette C. Schloot, MD         
Sponsors and Collaborators
German Diabetes Center
Heinrich-Heine University, Duesseldorf
Investigators
Principal Investigator: Nanette C Schloot, Priv.-Doz. MD German Diabetes Center, Duesseldorf
  More Information

No publications provided

Responsible Party: Schloot, Nanette C., German Diabetes Center
ClinicalTrials.gov Identifier: NCT01250106     History of Changes
Other Study ID Numbers: Probiotic-01
Study First Received: November 24, 2010
Last Updated: July 28, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by German Diabetes Center:
probiotics
prevention
dietary intervention
insulin resistance
obesity
type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014