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HealthyNCT04625088

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

A study testing Standardized liquid test meal and Atropine + Standardized liquid test meal in people with Healthy, run by SciMar Ltd. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Standardized liquid test meal and Atropine + Standardized liquid test meal
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteCanada
Study dates
1 Mar 2021to 6 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Kalo Medical Clinic

    Winnipeg, Manitoba, R2K 3Z5

Other trials in Canada

About this study

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)

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:

Read more
  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.

Conditions
Healthy
Being tested
Standardized liquid test meal, Atropine + Standardized liquid test meal
Keywords
Glucose; Insulin; Prediabetes
Medical subject headings
Insulin Resistance, Prediabetic State

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standardized liquid test mealOther

    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 mealDrug

    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.

Study groups in NCT04625088
Study groupRoleWhat they receive
Standardized liquid test mealExperimentalNot described
Receives: Other: Standardized liquid test meal
Atropine + Standardized liquid Test mealExperimentalNot described
Receives: Drug: Atropine + Standardized liquid test meal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

  2. 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

    Measured: 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

  3. 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

    Measured: 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

  4. 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

    Measured: 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)

  1. 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

    Measured: 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

  2. 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

    Measured: 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

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

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

    Measured: Control: Baseline fasted Test: 15 mins post atropine

  4. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2020
  2. Study start1 Mar 2021
  3. Primary completion6 Aug 2021
  4. Study completion6 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04625088
Sponsor's protocol ID
CT-001
Status last verified
Feb 2022
First submitted
29 Oct 2020
Last updated
3 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Standardized liquid test meal and Atropine + Standardized liquid test meal in people with Healthy, run by SciMar Ltd. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04625088.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.

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