Intestinimonas for Prevention of Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The study aims to assess the effects of a microbiota-based product containing Intestinimonas in adults with pre-diabetes. The purpose is to determine the safety and efficacy of the microbiota-based product on insulin sensitivity in a target group of prediabetic individuals. In particular, the objective is to evaluate whether Intestinimonas is able to improve the insulin sensitivity, the response to the oral glucose tolerance test (OGTT) and whether it is able to modulate the microbiota composition in the study subjects.

Detailed Description
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The study aims to assess the effects of a microbiota-based product containing Intestinimonas in adults with pre-diabetes. 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).

Official Title
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Novel Intestinal Microbiota-based Product for Preventing Type 2 Diabetes Mellitus

Conditions
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PreDiabetes

Intervention / Treatment
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* Dietary Supplement: Intestinimonas-capsules
* Dietary Supplement: Placebo-capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: increased BMI > 25, Fasting Plasma Glucose (FPG) 100-125 mg/dl or glucose > 140 after OGTT, or HbA1c 5.7% - 6.4% Exclusion Criteria: Type 2 diabetes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Double-blind, randomized, placebo-controlled study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental arm: Intestinimonas<br>Intestinimonas in capsules | Dietary Supplement: Intestinimonas-capsules<br>* Capsules containing microbiota (Intestinimonas)<br>|
| Placebo Comparator: Placebo arm: Placebo<br>Placebo in capsules | Dietary Supplement: Placebo-capsules<br>* Placebo capsules are identical to the active treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity | as measured by Homeostatic Model Assessment (HOMA) - index | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of Fasting glucose | as measured by Glucose in plasma | 12 weeks | 
| Level of 2-hour blood glucose Area Under the Curve (AUC) | as measured by standard Oral Glucose Tolerance Test (OGTT) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prediabetic State, Metabolic Syndrome