Back to resultsIntestinimonas for Prevention of Type 2 Diabetes Mellitus
Primary Purpose
PreDiabetes
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Intestinimonas-capsules
Placebo-capsules
Sponsored by
About this trial
This is an interventional treatment trial for PreDiabetes focused on measuring Prediabetic State, Metabolic Syndrome
Eligibility Criteria
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
Sites / Locations
- University Piemonte OrientaleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Experimental arm: Intestinimonas
Placebo arm: Placebo
Arm Description
Intestinimonas in capsules
Placebo in capsules
Outcomes
Primary Outcome Measures
Insulin sensitivity
as measured by Homeostatic Model Assessment (HOMA) - index
Secondary Outcome Measures
Concentration of Fasting glucose
as measured by Glucose in plasma
Level of 2-hour blood glucose Area Under the Curve (AUC)
as measured by standard Oral Glucose Tolerance Test (OGTT)
Full Information
NCT ID
NCT04495972
First Posted
July 27, 2020
Last Updated
February 14, 2023
Sponsor
Caelus Pharmaceuticals BV
1. Study Identification
Unique Protocol Identification Number
NCT04495972
Brief Title
Intestinimonas for Prevention of Type 2 Diabetes Mellitus
Official Title
Novel Intestinal Microbiota-based Product for Preventing Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Caelus Pharmaceuticals BV
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes
Keywords
Prediabetic State, Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Double-blind, randomized, placebo-controlled study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm: Intestinimonas
Arm Type
Active Comparator
Arm Description
Intestinimonas in capsules
Arm Title
Placebo arm: Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo in capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Intestinimonas-capsules
Intervention Description
Capsules containing microbiota (Intestinimonas)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo-capsules
Intervention Description
Placebo capsules are identical to the active treatment
Primary Outcome Measure Information:
Title
Insulin sensitivity
Description
as measured by Homeostatic Model Assessment (HOMA) - index
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Concentration of Fasting glucose
Description
as measured by Glucose in plasma
Time Frame
12 weeks
Title
Level of 2-hour blood glucose Area Under the Curve (AUC)
Description
as measured by standard Oral Glucose Tolerance Test (OGTT)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luc Sterkman, MD
Phone
+31622979249
Email
l.sterkman@caelushealth.com
Facility Information:
Facility Name
University Piemonte Orientale
City
Vercelli
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavia Prodam, MD
12. IPD Sharing Statement
Learn more about this trial
Intestinimonas for Prevention of Type 2 Diabetes Mellitus
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