Identification of Biometric Marker(s) Capable of Detecting Early Prediabetes: Clinical Trial 1
Status:
Recruiting
Trial end date:
2021-11-01
Target enrollment:
Participant gender:
Summary
The proposed clinical trial is a controlled study of n=24 healthy adult individuals tested in
both the Meal-Induced Insulin Sensitization (MIS) state and, following atropine blockade,
Absence of Meal-Induced Insulin Sensitization (AMIS) state to differentiate the postprandial
glycemia, insulinemia, triglyceride and Hepatic Insulin Sensitizing Substance (HISS) levels
in the two states.
The purpose of this study is the identification and development of biometric markers which
incorporate the actions and interplay between insulin and HISS. Overall, the study aims to:
1. Utilize a standardized test meal to detect one of the earliest pathologies present
during the development of insulin resistance, pre-diabetes and obesity.
2. Compare the control (HISS positive) and post-atropine (HISS negative) tests with the
acute consequences of absence of MIS (AMIS) being graphically shown over 4 hours of
postprandial nutrient partitioning, tracking the full metabolomic dynamic pattern.
3. To establish values for potential indices (bio-impedance, hand-grip strength,
spirometry) in young, fit, lean individuals. These values will be used as baselines for
comparative analysis in future clinical trials employing individuals with various
degrees of insulin resistance to full Type 2 Diabetes.
4. Demonstrate that these biometric markers can differentiate between the HISS positive and
HISS negative post-meal state with the future aim of using the biomarkers for the
detection of early prediabetes.
The study will involve 4 study visits: Visit 1 - Prescreening; Visit 2 - Screening; Visit 3 -
Liquid test meal administration and postprandial blood collection; Visit 4 - Atropine
administration + Liquid test meal administration and postprandial blood collection.