Intestinimonas for Prevention of Type 2 Diabetes Mellitus

Not Applicable

Completed

• Conditions: PreDiabetes
• Interventions: Dietary Supplement: Placebo-capsules; Dietary Supplement: Intestinimonas-capsules

• Registration Number: NCT04495972
• Lead Sponsor: Caelus Pharmaceuticals BV

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2020-07-27
• Study First Submitted QC: 2020-07-30
• Study First Posted: 2020-08-03
• Study Start: 2021-01-15
• Primary Completion: 2023-09-12
• Status Verified: 2023-11
• Study Completion: 2023-11-10
• Last Update Submitted: 2023-11-10
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo arm: Placebo	Placebo-capsules	Placebo in capsules
Experimental arm: Intestinimonas	Intestinimonas-capsules	Intestinimonas in capsules

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity	12 weeks	as measured by Homeostatic Model Assessment (HOMA) - index

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Piemonte Orientale; 🇮🇹 Vercelli, Italy