search
Back to results

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

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Standardized liquid test meal
Atropine + Standardized liquid test meal
Sponsored by
SciMar Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Healthy focused on measuring Glucose; Insulin; Prediabetes

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kalo Medical Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Standardized liquid test meal

Atropine + Standardized liquid Test meal

Arm Description

Outcomes

Primary Outcome Measures

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.
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 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
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

Secondary Outcome Measures

Time course change in serum free fatty acids
Time course and curve analysis of serum free fatty acid response after the test meal administration with and without atropine pre-treatment
Time course change in plasma lactate
Time course and curve analysis of plasma lactate response after the test meal administration with and without atropine pre-treatment
Time frame fasted HOMA-IR (Molar Units)
Time frame HOMA-IR, calculated using the formula: fasting insulin (mIU/L) X fasting glucose (mmol/L)
Time course change in Meal Induced Glycemia (MIG) scores (Molar Units)
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

Full Information

First Posted
October 29, 2020
Last Updated
February 2, 2022
Sponsor
SciMar Ltd.
Collaborators
Source Nutraceutical, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04625088
Brief Title
Identification of Biometric Marker(s) Capable of Detecting Early Prediabetes: Clinical Trial 1
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
August 6, 2021 (Actual)
Study Completion Date
August 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SciMar Ltd.
Collaborators
Source Nutraceutical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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: Utilize a standardized test meal to detect one of the earliest pathologies present during the development of insulin resistance, pre-diabetes and obesity. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Glucose; Insulin; Prediabetes

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standardized liquid test meal
Arm Type
Experimental
Arm Title
Atropine + Standardized liquid Test meal
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Standardized liquid test meal
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Atropine + Standardized liquid test meal
Intervention Description
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 Outcome Measure Information:
Title
Time course change in serum glucose
Description
Time course and curve analysis of serum glucose 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
Title
Time course change in serum insulin
Description
Time course and curve analysis of serum insulin response after the test meal administration with and without atropine pre-treatment
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
Title
Time course change in serum triglycerides
Description
Time course and curve analysis of serum triglycerides 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
Title
Time course change in plasma HISS levels
Description
Time course and curve analysis of plasma HISS response after the test meal administration with and without atropine pre-treatment
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
Secondary Outcome Measure Information:
Title
Time course change in serum free fatty acids
Description
Time course and curve analysis of serum free fatty acid 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
Title
Time course change in plasma lactate
Description
Time course and curve analysis of plasma lactate 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
Title
Time frame fasted HOMA-IR (Molar Units)
Description
Time frame HOMA-IR, calculated using the formula: fasting insulin (mIU/L) X fasting glucose (mmol/L)
Time Frame
Control: Baseline fasted Test: 15 mins post atropine
Title
Time course change in Meal Induced Glycemia (MIG) scores (Molar Units)
Description
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanu Ramprasath, PhD
Organizational Affiliation
Source Nutraceutical, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kalo Medical Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2K 3Z5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs