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

NCT04625088 | Completed

• 1 other identifier: CT-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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. 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.

Conditions

Healthy

Keywords

Glucose; Insulin; Prediabetes

Outcome Measures

Primary Outcomes (4)

• Time course change in serum glucose

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

  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 change in serum insulin

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

  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 change in serum triglycerides

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

  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 change in plasma HISS levels

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

  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

Secondary Outcomes (4)

• Time course change in serum free fatty acids

  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 change in plasma lactate

  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 frame fasted HOMA-IR (Molar Units)

  Control: Baseline fasted Test: 15 mins post atropine

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

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

Study Arms (2)

Standardized liquid test meal

EXPERIMENTAL

Other: Standardized liquid test meal

Atropine + Standardized liquid Test meal

EXPERIMENTAL

Drug: Atropine + Standardized liquid test meal

Interventions

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.

Standardized liquid 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.

Atropine + Standardized liquid Test meal

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• SciMar Ltd.: lead
• Source Nutraceutical, Inc.: collaborator

Study Sites (1)

Kalo Medical Clinic

Winnipeg, Manitoba, R2K 3Z5, Canada

Location

MeSH Terms

Conditions

Insulin Resistance; Prediabetic State

Interventions

Atropine

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Vanu Ramprasath, PhD

  Source Nutraceutical, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 12, 2020
• Study Start: March 1, 2021
• Primary Completion: August 6, 2021
• Study Completion: August 6, 2021
• Last Updated: February 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)