The Wellness Transformation Network Pilot Study

SciMar

Status

Completed

Conditions

Females Who Are Not Pregnant or Breast Feeding

Non-Diabetic

Treatments

Other: Standardized test meal

Study type

Interventional

Funder types

Industry

Identifiers

NCT05314036

WTN-001

Details and patient eligibility

About

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.

Full 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).

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.