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Completed

NCT Number: NCT05314036

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SNI Clinical Research

Winnipeg, Manitoba, R2K 3Z5, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standardized test meal

Other

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.

Primary outcomes

  1. Establishment of proposed Wellness Transformation Network clinical trial procedures.

    Time frame: 2 Weeks

    Practical feasibility of the proposed Wellness Transformation Network clinical trial procedures (Yes/No)

Secondary outcomes

  1. Time course and curve analysis of serum glucose response after the test meal administration.

    Time frame: Test: Baseline, every 30 minutes up to 2 hours after test meal administration

  2. Time course and curve analysis of serum insulin response after the test meal administration.

    Time frame: Test: Baseline, every 30 minutes up to 2 hours after test meal administration

  3. Time course and curve analysis of serum triglycerides response after the test meal administration.

    Time frame: Test: Baseline, every 30 minutes up to 2 hours after test meal administration

  4. Time course and curve analysis of plasma hepatalin response after the test meal administration.

    Time frame: Test: Baseline, every 30 minutes up to 2 hours after test meal administration

  5. Time course and curve analysis of Meal Induced Glycemia (MIG) scores response after the test meal administration.

    Time frame: Test: Baseline, every 30 minutes up to 2 hours after 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.

Sponsors and collaborators

Lead sponsor

SciMar Ltd.

Industry

Collaborators

  • Source Nutraceutical, Inc.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 6, 2022
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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