The Wellness Transformation Network Pilot Study

Establishment of a Standard Operating Procedure for Screening of the Pathologies Associated With Prediabetes and Diabetes -The Wellness Transformation Network Pilot Study.

The purpose of the study is to establish a Standard Operating Procedure (SOP) for the screening of pathologies associated with prediabetes and type 2 diabetes.

Study Overview

• Status: Completed
• Conditions: Non-Diabetic; Females Who Are Not Pregnant or Breast Feeding
• Intervention / Treatment: Other: Standardized test meal

Detailed Description

The proposed study will enable screening of pathologies associated with cardiometabolic diseases (i.e., hypertension, prediabetes, insulin resistance, diabetes, and obesity). The Meal-Induced Insulinemia and Glycemia (MIG) score will correlate with those dysfunctions that are components of the Absence of Meal-Induced Insulinemia (AMIS) syndrome. Overall the study aims:

1. To establish an SOP for screening pathologies associated with cardiometabolic diseases using a combination of biometrics and metabolomics.
2. To compare a participant's MIG score and hepatalin levels following consumption of a standardized test meal containing macronutrients, and the measurement of several indices of organ health associated with diabetes (i.e., body composition, handgrip strength, spirometry, blood pressure, and heart rate variability).

The study will involve 2 study visits: Visit 1 - Screening and Visit 2 - Intervention (Test meal administration and postprandial blood collection).

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2K 3Z5
      • SNI Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults (males and females)18 years of age or older.
• Able to understand and communicate in English.
• Willing to answer a questionnaire on lifestyle and health status.
• Willing to undergo measurements of height, weight, waist circumference, hip circumference, blood pressure, heart rate and heart rate variability, body mass index, handgrip strength (handgrip dynamometry) testing, and pulmonary function (spirometry) testing.
• Willing to fast for 12 hours prior to two in-person study visits.
• Willing to consume a standardized test meal containing food ingredients.
• Willing to provide a urine sample.
• Willing to take a pregnancy test (female participants of childbearing potential).
• Willing to provide the research team with a listing of all current medications and Natural Health Products(NHPs).
• Willing to complete an online eDiary, including a 3-day food record.
• Willing to give blood samples (finger prick and blood sampling at defined intervals using an intravenous catheter)

Exclusion Criteria:

• Individuals diagnosed with diabetes.
• Women with confirmed pregnancy or who are breastfeeding.
• Individuals with allergy or sensitivity to any component of the standardized test meal (i.e., dextrose, lecithin, soy protein).
• Individuals with a fasting blood glucose of 7.0 mmol/L or higher.
• Individuals with abnormal glucose in their urine.
• Individuals who are related to or working for the clinic site, research staff, and study sponsor.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acute Postprandial Blood Sampling; Two-hour postprandial blood sampling following administration of a standardized test meal	Other: Standardized test meal; During this study visit, a standardized test meal will be administered. Blood samples will be collected at baseline and then every 30 minutes for 2 hours after test meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establishment of proposed Wellness Transformation Network clinical trial procedures.	Practical feasibility of the proposed Wellness Transformation Network clinical trial procedures (Yes/No)	2 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time course and curve analysis of serum glucose response after the test meal administration.		Test: Baseline, every 30 minutes up to 2 hours after test meal administration
Time course and curve analysis of serum insulin response after the test meal administration.		Test: Baseline, every 30 minutes up to 2 hours after test meal administration
Time course and curve analysis of serum triglycerides response after the test meal administration.		Test: Baseline, every 30 minutes up to 2 hours after test meal administration
Time course and curve analysis of plasma hepatalin response after the test meal administration.		Test: Baseline, every 30 minutes up to 2 hours after test meal administration
Time course and curve analysis of Meal Induced Glycemia (MIG) scores response after the test meal administration.	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.	Test: Baseline, every 30 minutes up to 2 hours after test meal administration

Collaborators and Investigators

• Sponsor: SciMar Ltd.
• Collaborators: Source Nutraceutical, Inc.
• Investigators: Principal Investigator: Vanu Ramprasath, PhD, Source Nutraceutical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2022
• Primary Completion (Actual): April 5, 2022
• Study Completion (Actual): April 5, 2022

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Insulin; Prediabetes; Glucose
• Other Study ID Numbers: WTN-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No