Clinical trial NCT05314036: The Wellness Transformation Network Pilot Study
Official title: Establishment of a Standard Operating Procedure for Screening of the Pathologies Associated With Prediabetes and Diabetes -The Wellness Transformation Network Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Diabetic
Females Who Are Not Pregnant or Breast Feeding
Keywords: Glucose
Insulin
Prediabetes
Lead sponsor: SciMar Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Source Nutraceutical, Inc.
First posted: 2022-04-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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:

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).

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.

Primary outcomes:
measure: Establishment of proposed Wellness Transformation Network clinical trial procedures.
timeFrame: 2 Weeks
Secondary outcomes:
measure: Time course and curve analysis of serum glucose response after the test meal administration.
timeFrame: Test: Baseline, every 30 minutes up to 2 hours after test meal administration
measure: Time course and curve analysis of serum insulin response after the test meal administration.
timeFrame: Test: Baseline, every 30 minutes up to 2 hours after test meal administration
measure: Time course and curve analysis of serum triglycerides response after the test meal administration.
timeFrame: Test: Baseline, every 30 minutes up to 2 hours after test meal administration
measure: Time course and curve analysis of plasma hepatalin response after the test meal administration.
timeFrame: Test: Baseline, every 30 minutes up to 2 hours after test meal administration
measure: Time course and curve analysis of Meal Induced Glycemia (MIG) scores response after the test meal administration.
timeFrame: Test: Baseline, every 30 minutes up to 2 hours after test meal administration
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: SNI Clinical Research
state: Manitoba
Study officials:
affiliation: Source Nutraceutical, Inc.
name: Vanu Ramprasath, PhD
role: PRINCIPAL_INVESTIGATOR
References: