Identification of Biometric Marker(s) Capable of Detecting Early Prediabetes: Clinical Trial 1

  • STATUS
    Recruiting
  • End date
    Nov 1, 2021
  • participants needed
    24
  • sponsor
    SciMar Ltd.
Updated on 24 February 2021

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.

Details
Condition healthy
Treatment Standardized liquid test meal, Atropine + Standardized liquid test meal
Clinical Study IdentifierNCT04625088
SponsorSciMar Ltd.
Last Modified on24 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 20 yrs and 40 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have healthy??
Healthy (absence of disease)
Not on any prescribed medications
Male and female (in follicular phase)
-40 years of age
Normal BMI range (18.5-24.9)
Able to understand and communicate in English
Comfortable having blood drawn
Willing to provide urine and blood samples
Normal urinalysis, Complete Blood Count (CBC) and blood chemistry laboratory test results
Willingness to undergo bioimpedance testing, handgrip dynamometry (strength) testing, and pulmonary function test (spirometry)
Willingness to undergo atropine administration
Willingness to fast for 12 hours prior to the screening and testing days
Willingness to undergo Electrocardiogram (ECG) and Heart Rate Variability (HRV) testing
Willingness to use non-hormonal birth control methods throughout the study duration

Exclusion Criteria

Glaucoma, Pyloric Stenosis
Obstructive Uropathy, Urinary Incontinence
Diabetes, Cardiovascular Disease, including Heart Murmurs
Diagnosed or with history (last 6 months) and receiving pharma or professional therapy for Psychological/Psychiatric issues
Inflammatory conditions, including IBD
Subject on any hormone treatment, including thyroid hormone
Subject on any steroid therapy including cortisol, or any anti-inflammatory agent
Sensitivity to anti-cholinergic drugs
Allergic or have sensitivities to rubbing alcohol during blood draw
Allergy/sensitivity to any component of the standardized test meal (dextrose, lecithin, soy protein)
Pregnant women, women of child-bearing potential not willing to use barrier method contraceptives, women trying to get pregnant, and breastfeeding women, women using hormonal birth control
Whole blood donation (50-499 ml of whole blood) within 30 days, and more than 499 ml of whole blood 56 days prior to test visit 1. Participants should not donate whole blood for the duration of the trial, and for 30 days following the end of the trial
Blood pressure greater than 140/90 mmHg and heart rate greater than or equal to 80 beats per minute
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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