Probiotics as a Novel Approach to Modulate Gut Hormone Se... | NCT01250106

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

NCT01250106

Sponsor

German Diabetes Center

Status

Unknown status

Last Update Posted

Jul 29, 2011Estimated

Enrollment

20Estimated

Phase

Phase 1Phase 2

Conditions

Obesity
Type 2 Diabetes

Interventions

Lactobacillus reuteri

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Dec 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Nov 24, 2010

First Submission Date that Met QC Criteria

Nov 29, 2010

First Posted Date

Nov 30, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2011

Last Update Posted Date

Jul 29, 2011Estimated

Name	Class
Heinrich-Heine University, Duesseldorf	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Probiotic capsule	Experimental		Dietary Supplement: Lactobacillus reuteri
placebo capsule	Placebo Comparator		Dietary Supplement: Lactobacillus reuteri

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lactobacillus reuteri	Dietary Supplement	twice daily	Probiotic capsule placebo capsule

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Insulin resistance		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
gut hormones (GLP-1, GLP-2, GIP)		8 and 10 weeks
insulin secretion		8 and 10 weeks
measurement of cytokines to define the immune status

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nanette C Schloot, MD	Contact	+49 211 3382	665	schloot@ddz.uni-duesseldorf.de
Marie-Christine Simon, Dipl. oecotroph.	Contact	+49 211 3382	229	marie-christine.simon@ddz.uni-duesseldorf.de

Overall Officials

Name	Affiliation	Role
Nanette C Schloot, Priv.-Doz. MD	German Diabetes Center, Duesseldorf	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
German Diabetes Center	Recruiting	Düsseldorf	Duesseldorf	40225	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26084343	Derived	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.

Type	Date	Date Unknown
Release	Aug 4, 2023
Reset	Mar 7, 2024
Release	Jan 9, 2025
Reset	Feb 3, 2025

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 4, 2023			Mar 7, 2024
Jan 9, 2025

ID	Term
D009765	Obesity
D003924	Diabetes Mellitus, Type 2
D007333	Insulin Resistance

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases