NCT05314036

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: SciMar Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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: 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).

Conditions

• Non-Diabetic
• Females Who Are Not Pregnant or Breast Feeding

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-17
• Primary completion: 2022-04-05
• Completion: 2022-04-05
• First posted: 2022-04-06
• Last updated: 2022-04-22

Locations

1 site across 1 country: Canada