Intestinimonas for Prevention of Type 2 Diabetes Mellitus
NCT ID: NCT04495972
Last Updated: 2023-11-13
Study Results
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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COMPLETED
NA
26 participants
INTERVENTIONAL
2021-01-15
2023-11-10
Brief Summary
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Detailed Description
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Intestinimonas is an aerobic microorganism which produces butyrate and interacts with the local microbiota in small and large intestine.
In preclinical studies, it was demonstrated that the insulin sensitivity can be enhanced by Intestinimonas and similar microbiota.
The purpose is to determine the safety and efficacy of the microbiota-based product on insulin sensitivity in a target group of prediabetic individuals.
The study participants will be subjects who are overweight and are at risk of developing Type 2 diabetes.
The key objective of this randomized, placebo-controlled study is to evaluate whether Intestinimonas is able to improve the insulin sensitivity, to assess the response to the oral glucose tolerance test (OGTT) and whether it is able to modulate the microbiota composition in the study subjects.
Furthermore, in a open-label follow-up of 14 weeks the effect of a high-dose of Intestinimonas will be compared with the low-dose tested in the initial double-blind Randomised Controlled Trial (RCT).
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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Experimental arm: Intestinimonas
Intestinimonas in capsules
Intestinimonas-capsules
Capsules containing microbiota (Intestinimonas)
Placebo arm: Placebo
Placebo in capsules
Placebo-capsules
Placebo capsules are identical to the active treatment
Interventions
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Intestinimonas-capsules
Capsules containing microbiota (Intestinimonas)
Placebo-capsules
Placebo capsules are identical to the active treatment
Eligibility Criteria
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Inclusion Criteria
* Fasting Plasma Glucose (FPG) 100-125 mg/dl or glucose \> 140 after OGTT, or HbA1c 5.7% - 6.4%
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Caelus Pharmaceuticals BV
INDUSTRY
Responsible Party
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Locations
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University Piemonte Orientale
Vercelli, , Italy
Countries
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Other Identifiers
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DM Prevent POC
Identifier Type: -
Identifier Source: org_study_id
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