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Completed

NCT Number: NCT04495972

Intestinimonas for Prevention of Type 2 Diabetes Mellitus

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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Piemonte Orientale

Vercelli, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intestinimonas-capsules

Dietary Supplement

Capsules containing microbiota (Intestinimonas)

Placebo-capsules

Dietary Supplement

Placebo capsules are identical to the active treatment

Primary outcomes

  1. Insulin sensitivity

    Time frame: 12 weeks

    as measured by Homeostatic Model Assessment (HOMA) - index

Secondary outcomes

  1. Concentration of Fasting glucose

    Time frame: 12 weeks

    as measured by Glucose in plasma

  2. Level of 2-hour blood glucose Area Under the Curve (AUC)

    Time frame: 12 weeks

    as measured by standard Oral Glucose Tolerance Test (OGTT)

Sponsors and collaborators

Lead sponsor

Caelus Pharmaceuticals BV

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 3, 2020
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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