- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01250106
Probiotics as a Novel Approach to Modulate Gut Hormone Secretion and Risk Factors of Type 2 Diabetes and Complications
July 28, 2011 updated by: German Diabetes Center
Phase I Study of Probiotics as a Novel Approach to Modulate Gut Hormone Secretion and Risk Factors of Type 2 Diabetes and Complications
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nanette C Schloot, MD
- Phone Number: 665 +49 211 3382
- Email: schloot@ddz.uni-duesseldorf.de
Study Contact Backup
- Name: Marie-Christine Simon, Dipl. oecotroph.
- Phone Number: 229 +49 211 3382
- Email: marie-christine.simon@ddz.uni-duesseldorf.de
Study Locations
-
-
Duesseldorf
-
Düsseldorf, Duesseldorf, Germany, 40225
- Recruiting
- German Diabetes Center
-
Contact:
- Nanette C Schloot, MD
- Phone Number: 665 +49 211 3382
- Email: schloot@ddz.uni-duesseldorf.de
-
Contact:
- Marie-Christine Simon, Dipl. Oecotroph
- Phone Number: 229 +49 211 3382
- Email: marie-christine.simon@ddz.uni-duesseldorf.de
-
Principal Investigator:
- Nanette C. Schloot, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Probiotic capsule
|
twice daily
|
Placebo Comparator: placebo capsule
|
twice daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Insulin resistance
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
gut hormones (GLP-1, GLP-2, GIP)
Time Frame: 8 and 10 weeks
|
8 and 10 weeks
|
|
insulin secretion
Time Frame: 8 and 10 weeks
|
8 and 10 weeks
|
|
measurement of cytokines to define the immune status
Time Frame: 8 and 10 weeks
|
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
|
8 and 10 weeks
|
body weight
Time Frame: 8 and 10 weeks
|
8 and 10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nanette C Schloot, Priv.-Doz. MD, German Diabetes Center, Duesseldorf
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Anticipated)
December 1, 2011
Study Completion (Anticipated)
December 1, 2011
Study Registration Dates
First Submitted
November 24, 2010
First Submitted That Met QC Criteria
November 29, 2010
First Posted (Estimate)
November 30, 2010
Study Record Updates
Last Update Posted (Estimate)
July 29, 2011
Last Update Submitted That Met QC Criteria
July 28, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Probiotic-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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