Novel Intestinal Microbiota-based Product for Preventing Type 2 Diabetes Mellitus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Caelus Pharmaceuticals BV
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Insulin sensitivity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Experimental arm: Intestinimonas
Intestinimonas in capsules
Intervention: Intestinimonas-capsules (Dietary Supplement)
Placebo arm: Placebo
Placebo in capsules
Intervention: Placebo-capsules (Dietary Supplement)
Outcomes
Primary Outcomes
Insulin sensitivity
Time Frame: 12 weeks
as measured by Homeostatic Model Assessment (HOMA) - index
Secondary Outcomes
- Level of 2-hour blood glucose Area Under the Curve (AUC)(12 weeks)
- Concentration of Fasting glucose(12 weeks)