- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03446183
Short Term Effect of Smoking Cessation on Human Metabolism
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Objective: To examine metabolic aspects occurring during the first 6-12 months following smoking cessation in participants of smoking cessation workshops.
Design: A two armed study: prospective and retrospective. Prospective: Weight, BMI, waist circumference and waist: hip ratio were measured before, during and 6 months post cessation program. Retrospective: Blood test data for Blood fasting glucose (BFG) and lipid profile from the year preceding the workshops and the year after them were analyzed from participants' files. Smoking status was verified by phone conversation.
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Volunteers who were recruited from the smoking cessation workshops of the Meuhedet HMO (Israeli Health Services) during 2016-2017.
Exclusion Criteria:
- Candidates with benign tumors, bariatric surgeries, and endoscopic bariatric procedures before or during the study period were excluded
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Smoking cessation prospective
Smoking cessation workshops
|
All the participants took part in smoking cessation workshops.
The comparison of metabolic aspects was made between the smokers and non-smokers
|
|
Smoking cessation retrospective
File review of former workshop participants
|
All the participants took part in smoking cessation workshops.
The comparison of metabolic aspects was made between the smokers and non-smokers
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in weight
Tidsramme: 6 months from baseline
|
Weight in meters
|
6 months from baseline
|
|
Change in BMI
Tidsramme: 6 months from baseline
|
BMI in kg/m2
|
6 months from baseline
|
|
Change in waist and hip circumference
Tidsramme: 6 months from baseline
|
Waist and hip curcumference in centimeters
|
6 months from baseline
|
|
Change in Blood fasting glucose according to patient files (unspecified time points up to a year before and a year after the workshops)
Tidsramme: up to 2 years from baseline
|
BFG in mg/dl
|
up to 2 years from baseline
|
|
Change in lipid profile according to patient files (unspecified time points up to a year before and a year after the workshops)
Tidsramme: up to 2 years from baseline
|
Lipid particle measurements in mg/dl
|
up to 2 years from baseline
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- smoking cessation
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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-
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-
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-
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-
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-
University Hospital, Clermont-FerrandRekruttering