The Wellness Transformation Network Pilot Study

Study Overview
=================
Brief Summary
-----------------
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.

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: To establish an SOP for screening pathologies associated with cardiometabolic diseases using a combination of biometrics and metabolomics. 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).

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

Conditions
-----------------
Non-Diabetic, Females Who Are Not Pregnant or Breast Feeding

Intervention / Treatment
-----------------
* Other: Standardized test meal


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute Postprandial Blood Sampling<br>Two-hour postprandial blood sampling following administration of a standardized test meal | Other: Standardized test meal<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glucose, Insulin, Prediabetes