The Wellness Transformation Network Pilot Study
21. april 2022 oppdatert av: SciMar Ltd.
Establishment of a Standard Operating Procedure for Screening of the Pathologies Associated With Prediabetes and Diabetes -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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Intervensjonell
Registrering (Faktiske)
15
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Manitoba
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Winnipeg, Manitoba, Canada, R2K 3Z5
- SNI Clinical Research
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Acute Postprandial Blood Sampling
Two-hour postprandial blood sampling following administration of a standardized test meal
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Establishment of proposed Wellness Transformation Network clinical trial procedures.
Tidsramme: 2 Weeks
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Practical feasibility of the proposed Wellness Transformation Network clinical trial procedures (Yes/No)
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2 Weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Time course and curve analysis of serum glucose response after the test meal administration.
Tidsramme: Test: Baseline, every 30 minutes up to 2 hours after test meal administration
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Test: Baseline, every 30 minutes up to 2 hours after test meal administration
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Time course and curve analysis of serum insulin response after the test meal administration.
Tidsramme: Test: Baseline, every 30 minutes up to 2 hours after test meal administration
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Test: Baseline, every 30 minutes up to 2 hours after test meal administration
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Time course and curve analysis of serum triglycerides response after the test meal administration.
Tidsramme: Test: Baseline, every 30 minutes up to 2 hours after test meal administration
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Test: Baseline, every 30 minutes up to 2 hours after test meal administration
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Time course and curve analysis of plasma hepatalin response after the test meal administration.
Tidsramme: Test: Baseline, every 30 minutes up to 2 hours after test meal administration
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Test: Baseline, every 30 minutes up to 2 hours after test meal administration
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Time course and curve analysis of Meal Induced Glycemia (MIG) scores response after the test meal administration.
Tidsramme: Test: Baseline, every 30 minutes up to 2 hours after test meal administration
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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.
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Test: Baseline, every 30 minutes up to 2 hours after test meal administration
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Vanu Ramprasath, PhD, Source Nutraceutical, Inc.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
17. januar 2022
Primær fullføring (Faktiske)
5. april 2022
Studiet fullført (Faktiske)
5. april 2022
Datoer for studieregistrering
Først innsendt
10. februar 2022
Først innsendt som oppfylte QC-kriteriene
5. april 2022
Først lagt ut (Faktiske)
6. april 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. april 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. april 2022
Sist bekreftet
1. april 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- WTN-001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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