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

NCT ID: NCT01250106

Last Updated: 2011-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity Type 2 Diabetes

Keywords

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probiotics prevention dietary intervention insulin resistance obesity type 2 diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotic capsule

Group Type EXPERIMENTAL

Lactobacillus reuteri

Intervention Type DIETARY_SUPPLEMENT

twice daily

placebo capsule

Group Type PLACEBO_COMPARATOR

Lactobacillus reuteri

Intervention Type DIETARY_SUPPLEMENT

twice daily

Interventions

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Lactobacillus reuteri

twice daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role collaborator

German Diabetes Center

OTHER

Sponsor Role lead

Responsible Party

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German Diabetes Center

Principal Investigators

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Nanette C Schloot, Priv.-Doz. MD

Role: PRINCIPAL_INVESTIGATOR

German Diabetes Center, Duesseldorf

Locations

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German Diabetes Center

Düsseldorf, Duesseldorf, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Nanette C Schloot, MD

Role: CONTACT

Phone: +49 211 3382

Email: [email protected]

Marie-Christine Simon, Dipl. oecotroph.

Role: CONTACT

Phone: +49 211 3382

Email: [email protected]

Facility Contacts

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Nanette C Schloot, MD

Role: primary

Marie-Christine Simon, Dipl. Oecotroph

Role: backup

References

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Simon MC, Strassburger K, Nowotny B, Kolb H, Nowotny P, Burkart V, Zivehe F, Hwang JH, Stehle P, Pacini G, Hartmann B, Holst JJ, MacKenzie C, Bindels LB, Martinez I, Walter J, Henrich B, Schloot NC, Roden M. Intake of Lactobacillus reuteri improves incretin and insulin secretion in glucose-tolerant humans: a proof of concept. Diabetes Care. 2015 Oct;38(10):1827-34. doi: 10.2337/dc14-2690. Epub 2015 Jun 17.

Reference Type DERIVED
PMID: 26084343 (View on PubMed)

Other Identifiers

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Probiotic-01

Identifier Type: -

Identifier Source: org_study_id