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Completed

NCT Number: NCT04625088

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

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.

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Key information

Conditions

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

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kalo Medical Clinic

Winnipeg, Manitoba, R2K 3Z5, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy (absence of disease)
  • Not on any prescribed medications
  • Male and female (in follicular phase)
  • 20-40 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

Treatment and study plan

Standardized liquid test meal

Other

During this study visit, a standardized liquid test meal will be administered. Blood samples will be collected at baseline and then every 30 minutes for 4 hours after test meal.

Atropine + Standardized liquid test meal

Drug

During this study visit, 1.0 mg atropine will be administered I.V and then a standardized liquid test meal will be administered. Blood samples will be collected at baseline, following atropine administration, and then every 30 minutes for 4 hours after test meal.

Primary outcomes

  1. Time course change in serum glucose

    Time frame: Control: Baseline, and every 30 minutes up to 4 hours after test meal administration; Test: Baseline, 15 mins post atropine and every 30 minutes up to 4 hours after test meal administration

    Time course and curve analysis of serum glucose response after the test meal administration with and without atropine pre-treatment.

  2. Time course change in serum insulin

    Time frame: Time Frame: Control: Baseline, and every 30 minutes up to 4 hours after test meal administration; Test: Baseline, 15 mins post atropine and every 30 minutes up to 4 hours after test meal administration

    Time course and curve analysis of serum insulin response after the test meal administration with and without atropine pre-treatment

  3. Time course change in serum triglycerides

    Time frame: Control: Baseline, and every 30 minutes up to 4 hours after test meal administration; Test: Baseline, 15 mins post atropine and every 30 minutes up to 4 hours after test meal administration

    Time course and curve analysis of serum triglycerides response after the test meal administration with and without atropine pre-treatment

  4. Time course change in plasma HISS levels

    Time frame: Time Frame: Control: Baseline, and every 30 minutes up to 4 hours after test meal administration; Test: Baseline, 15 mins post atropine and every 30 minutes up to 4 hours after test meal administration

    Time course and curve analysis of plasma HISS response after the test meal administration with and without atropine pre-treatment

Secondary outcomes

  1. Time course change in serum free fatty acids

    Time frame: Control: Baseline, and every 30 minutes up to 4 hours after test meal administration; Test: Baseline, 15 mins post atropine and every 30 minutes up to 4 hours after test meal administration

    Time course and curve analysis of serum free fatty acid response after the test meal administration with and without atropine pre-treatment

  2. Time course change in plasma lactate

    Time frame: Control: Baseline, and every 30 minutes up to 4 hours after test meal administration; Test: Baseline, 15 mins post atropine and every 30 minutes up to 4 hours after test meal administration

    Time course and curve analysis of plasma lactate response after the test meal administration with and without atropine pre-treatment

  3. Time frame fasted HOMA-IR (Molar Units)

    Time frame: Control: Baseline fasted Test: 15 mins post atropine

    Time frame HOMA-IR, calculated using the formula: fasting insulin (mIU/L) X fasting glucose (mmol/L)

  4. Time course change in Meal Induced Glycemia (MIG) scores (Molar Units)

    Time frame: Control: Every 30 minutes up to 4 hours after test meal administration; Test: Every 30 minutes up to 4 hours after test meal administration

    Time course and curve analysis of Meal Induced Glycemia (MIG) scores response after the test meal administration with and without atropine pre-treatment. MIG is calculated using the formula: MIG = (post meal insulin mIU/L X post meal glucose mmol/L) minus (fasted insulin mIU/L X fasted glucose mmol/L). Higher score equates to a worse (unhealthy) outcome

Sponsors and collaborators

Lead sponsor

SciMar Ltd.

Industry

Collaborators

  • Source Nutraceutical, Inc.

Registry information

Official study title

Identification of Biometric Marker(s) Capable of Detecting Early Prediabetes: Clinical Trial 1: Antagonism of Hepatic Muscarinic Receptors Attenuates the Postprandial Actions of Hepatic Insulin Sensitizing Substance (HISS)

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 12, 2020
Registry last updated
Feb 3, 2022

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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