Probiotics as a Novel Approach to Modulate Gut Hormone Secretion and Risk Factors of Type 2 Diabetes and Complications
Phase I Study of Probiotics as a Novel Approach to Modulate Gut Hormone Secretion and Risk Factors of Type 2 Diabetes and Complications
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 obesity
Started Nov 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 24, 2010
CompletedFirst Posted
Study publicly available on registry
November 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJuly 29, 2011
July 1, 2011
1.1 years
November 24, 2010
July 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insulin resistance
8 weeks
Secondary Outcomes (4)
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
8 and 10 weeks
body weight
8 and 10 weeks
Study Arms (2)
Probiotic capsule
EXPERIMENTALplacebo capsule
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- pregnancy, cancer, chronic diseases, antibiotic therapy, competitive athletes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- German Diabetes Centerlead
- Heinrich-Heine University, Duesseldorfcollaborator
Study Sites (1)
German Diabetes Center
Düsseldorf, Duesseldorf, 40225, Germany
Related Publications (1)
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.
PMID: 26084343DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nanette C Schloot, Priv.-Doz. MD
German Diabetes Center, Duesseldorf
Central Study Contacts
Marie-Christine Simon, Dipl. oecotroph.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 24, 2010
First Posted
November 30, 2010
Study Start
November 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
July 29, 2011
Record last verified: 2011-07