Udforsk de antiinflammatoriske egenskaber ved cannabis og deres relevans for insulinfølsomhed (SONIC)
14. juli 2026 opdateret af: Angela Bryan, University of Colorado, Boulder
Denne undersøgelse tester virkningerne af cannabinoidniveauer i blodet på inflammation og insulinfølsomhed både akut og kronisk hos individer på tværs af vægtspektret.
Til det formål anvender undersøgelsen to observationsdesigns: 1) En undersøgelse af akutte effekter med intermitterende cannabisbrugere og 2) En undersøgelse, hvor nuværende cannabisbrugere vil vælge en af tre cannabisstammer i fire uger og sammenlignes med en matchet kontrolgruppe som ikke bruger cannabis til at studere kroniske effekter.
Blodniveauer af THC og CBD, inflammatoriske biomarkører og insulinresistens vil blive målt i begge undersøgelser.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Ifølge National Institute of Diabetes and Digestive and Kidney Diseases har over 30 millioner mennesker i USA diabetes, og lidt over 84 millioner mennesker har præ-diabetes. Samtidig har 30 stater og District of Columbia legaliseret cannabis til medicinsk og/eller rekreativt brug, og i løbet af det sidste årti er cannabisbrug blandt voksne mere end fordoblet.
Offentlig opfattelse og nogle videnskabelige data tyder på, at cannabis forårsager akut overspisning, hvilket skaber bekymring for, at offentlig og juridisk accept af cannabisbrug vil forværre fedmeepidemien i USA, hvor mere end to tredjedele af amerikanske voksne (68,8 %) i øjeblikket er overvægtige eller fede. Paradoksalt nok viser tværsnitsdata sammenhænge mellem kronisk cannabisbrug og lavere kropsmasseindeks (BMI), forekomst af fedme, insulinresistens, taljeomkreds og faktiske rater af type 2-diabetes på trods af data, der understøtter højere kalorieindtag akut.
Denne undersøgelse undersøger virkningerne af cannabinoidniveauer i blodet på inflammation og insulinfølsomhed både akut og kronisk hos individer på tværs af vægtspektret. Til det formål anvender undersøgelsen to observationsdesigns: 1) En undersøgelse af akutte effekter med intermitterende cannabisbrugere og 2) En undersøgelse, hvor nuværende cannabisbrugere vil vælge en af tre cannabisstammer i fire uger og sammenlignes med en matchet kontrolgruppe som ikke bruger cannabis til at studere kroniske effekter.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
233
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Colorado
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Boulder, Colorado, Forenede Stater, 80301
- Center for Innovation and Creativity
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
21 år til 40 år (Voksen)
Tager imod sunde frivillige
N/A
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Samfundsprøve
Beskrivelse
Inklusionskriterier:
- Kan give informeret samtykke
- Cannabisbrugere i undersøgelse A skal have røget eller dampet cannabis mindst én gang siden 1. januar 2014 uden negative effekter, men IKKE brugt inden for de seneste tre måneder
- Cannabisbrugere i undersøgelse B skal have været en almindelig (mindst ugentlig) bruger i mindst et år
- Ikke-brugere i undersøgelse B kan ikke have brugt cannabis i det foregående år
- Vægt stabil (<5 pund udsving inden for de seneste seks måneder)
- Planlægger at blive i Boulder-Denver-området i den næste måned
- Fastende blodsukker større end eller lig med 55 mg/dl og mindre end eller lig med 126 mg/dl
- Cannabisbrugere i undersøgelse A skal godkende viden om procedurerne for rygning eller dampning af cannabis
Ekskluderingskriterier:
- Kendt autoimmun sygdom
- Indberetning af andet stofbrug (kokain, opiater, metamfetamin) inden for de seneste 90 dage eller mislykket urinscreening for nogen af disse stoffer
- Daglig tobaksbruger (cigaret, E-cigs, røgfri) i betragtning af tobaksrygningens indvirkning på insulinfunktionen
- Blodpromille højere end 0 ved screening
- Nuværende brug af medicin til glukosesænkende, immunsuppression eller anti-inflammation
- Akut sygdom
- Nuværende brug af psykotrope lægemidler
- Nuværende diagnose af diabetes
- Stærkt drikkeri som defineret af en alkoholforbrugsforstyrrelsestest (AUDIT)
- Kvinder kan ikke være gravide eller forsøge at blive gravide
- Kvinder kan ikke være ammende mødre
- Har doneret blod i de 8 uger før undersøgelsen eller har til hensigt at donere blod i de 8 uger efter undersøgelsen.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Undersøgelse A
Voksne balancerede på tværs af vægtspektret, som har prøvet cannabis mindst én gang uden negativ reaktion, men som ikke er regelmæssige brugere.
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Deltagerne bliver bedt om at købe og bruge en af tre cannabisblomststammer med forskellige niveauer af THC og CBD: 1) CBD (~14% CBD/0% THC), 2) THC (~14% THC/0% CBD) eller 3) THC+CBD (~7% THC/7% CBD).
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Studie B
Udvalg af aktuelle cannabisbrugere og ikke-brugere balanceret på tværs af vægtspektret, som matches på alder, køn, BMI og fysisk aktivitet.
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Deltagerne vælger, om de vil bruge et cannabisblomstprodukt ad libitum i fire uger eller ikke at bruge cannabis i fire uger.
Deltagere, der vælger at bruge cannabis, bliver bedt om at købe og bruge en af tre cannabisblomststammer med forskellige niveauer af THC og CBD: 1) CBD (~14% CBD/0% THC), 2) THC (~14% THC/0) % CBD), eller 3) THC+CBD (~7 % THC/7 % CBD).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Markers of Inflammation
Tidsramme: Study A: Difference between cytokines at baseline and cytokines one week later after acute use of cannabis product. Study B: Change from baseline to four weeks
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Change in Circulating Levels of Cytokines (TNF-α, IL-6, IL-1β, IL-12, IFNG, and IL-4).
Results are reported as a composite score of TNF-α, IL-6, IL-1β, IL-12, IFNG, and IL-4
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Study A: Difference between cytokines at baseline and cytokines one week later after acute use of cannabis product. Study B: Change from baseline to four weeks
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Change in Matsuda Index of Insulin Sensitivity
Tidsramme: Study A: Baseline versus after acute use one week later of cannabis product. Study B: The two tests will be separated by four weeks
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Calculation of Insulin Sensitivity using changes in fasting plasma glucose (FPG) and fasting plasma insulin (FPI). Measurements are collected on venous blood samples at 0, 30, 60, 90, and 120 minutes after ingestion of 75 grams oral glucose during oral glucose tolerance test (OGTT). Values across the timepoints were combined to create a Matsuda Index score as follows: 10000/sqrt ((FPG X FPI) X (Mean OGTT glucose concentration X Mean OGTT insulin concentration)). Higher scores mean higher sensitive to insulin and that your body more efficiently clears glucose from your bloodstream, thus higher scores are better. |
Study A: Baseline versus after acute use one week later of cannabis product. Study B: The two tests will be separated by four weeks
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Change in Plasma Glucose
Tidsramme: Study A: Baseline versus one week later after acute use of cannabis product. Study B: The two tests will be separated by four weeks
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Change in glucose over time after ingestion of 75 grams oral glucose measured during during oral glucose tolerance test (OGTT).
Measurements are collected on venous blood samples at 0, 30, 60, 90, and 120 minutes and averaged across these timepoints for a mean score.
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Study A: Baseline versus one week later after acute use of cannabis product. Study B: The two tests will be separated by four weeks
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Change in Plasma Insulin
Tidsramme: Study A: Baseline versus one week later after acute use of cannabis product. Study B: Baseline versus four weeks later
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Change in insulin over time after ingestion of 75 grams oral glucose measured during OGTT.
Measurements are collected on venous blood samples at 0, 30, 60, 90, and 120 minutes and averaged across these timepoints for a mean score.
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Study A: Baseline versus one week later after acute use of cannabis product. Study B: Baseline versus four weeks later
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Stanford Seven-Day Physical Activity Recall (PAR)
Tidsramme: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
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Interviewer administered assessment of number of minutes of moderate to vigorous physical activity over the previous seven days.
Scores are reported as total minutes in the last week summed across moderate, hard, and very hard activity levels.
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Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
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Sleep Quality
Tidsramme: Study A: Baseline only Study B: Baseline to four weeks following baseline
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Pittsburgh Sleep Quality Index: Measurement of the quality and patterns of sleep from poor to good measuring seven domains (e.g., latency, duration, disturbances) over the last 2 weeks.
Participants' scores are reported as a global score of the summed seven component scores together ranging from 0 to 21, where higher scores indicate worse sleep and a global score of 5 or above indicates poor sleep quality.
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Study A: Baseline only Study B: Baseline to four weeks following baseline
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Marijuana Consumption Questionnaire
Tidsramme: Study A: Baseline only. Study B: Baseline and four weeks following baseline
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Times per day of cannabis flower use from 0 to 6. Includes all participants in Study A and only cannabis users in Study B.
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Study A: Baseline only. Study B: Baseline and four weeks following baseline
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Marijuana Dependence Scale
Tidsramme: Study A: Baseline only. Study B: Baseline and four weeks following baseline
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This is a self-report scale based on DSM-5 criteria to assess dependence and other problems related to the use of cannabis.
Scores are reported as a sum across the 11 items with yes/no options, ranging from 0 to 11, with higher scores indicating more dependence symptoms.
Includes all participants in Study A and only cannabis users in Study B.
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Study A: Baseline only. Study B: Baseline and four weeks following baseline
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Marijuana Withdrawal Checklist
Tidsramme: Study A: Assessed at follow-up, one week following baseline. Study B: Assessed at follow-up, four weeks following baseline.
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A 15-item scale used to collect information on withdrawal symptoms that participants may be experiencing due to the lack of use of marijuana.
Options range from 0 (none) to 3 (severe) for each question and are summed to create a final score ranging from 0 to 45. Includes all participants in Study A and only cannabis users in Study B.
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Study A: Assessed at follow-up, one week following baseline. Study B: Assessed at follow-up, four weeks following baseline.
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The Alcohol Use Disorder Identification Test (AUDIT)
Tidsramme: Study A: Baseline only. Study B: Baseline and four weeks following baseline
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Standardized assessment of the extent of alcohol use and problems related to alcohol use.
Scores are summed and range from 0 to 40 with higher scores indicating more hazardous alcohol use.
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Study A: Baseline only. Study B: Baseline and four weeks following baseline
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Timeline Follow-Back of Substance Use
Tidsramme: Study A: Baseline only. Study B: Baseline and four weeks following baseline
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Calendar-based assessment of daily substance use for the 30 days prior to the baseline session for both studies.
The average days of smoked cannabis use in the last 30 days are reported.
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Study A: Baseline only. Study B: Baseline and four weeks following baseline
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SF-12 Health Survey
Tidsramme: Study A: Baseline only. Study B: Baseline and four weeks following baseline
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The SF-12 Health Survey is a 12-item questionnaire used to assess general health and well-being and includes domains of physical functioning, role-physical, pain, general health, vitality, social functioning, role-emotional and mental health.
Only the mental component was analyzed.
Scores are calculated using a weighted algorithm with scores ranging from 0 to 100; scores greater than 50 meaning better than average health and scores worse than 50 meaning worse than average health.
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Study A: Baseline only. Study B: Baseline and four weeks following baseline
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Nutrition Data System for Research 24-Hour Dietary Recall
Tidsramme: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
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Interviewer administered recall measure developed by the University of Minnesota Nutrition Coordinating Center (NCC), that facilitates the standardized collection of 24-hour dietary recall data.
Healthy Eating Index (HEI) total scores are reported for each participant, which is a measure of healthy eating on a scale of 0 (poor eating) to 100 (very healthy eating).
Scores above 80 indicate a good diet, and scores below 80 indicate a diet in need of improvement.
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Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
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Stanford Leisure-Time Activity Categorical Item (L-Cat)
Tidsramme: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
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Self-report measure of a single item comprising six descriptive categories ranging from inactive (1) to very active (6).
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Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Daily Online Survey of Alcohol Use
Tidsramme: Study B only: Daily for four weeks between baseline and second study visit
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Daily surveys sent to Study B participants during the four-week period between study visits querying alcohol use.
This is reported as average number of drinks/day of alcohol use.
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Study B only: Daily for four weeks between baseline and second study visit
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Daily Only Survey of Exercise
Tidsramme: Study B only: Daily for four weeks between baseline and second study visit
|
Daily surveys sent to Study B participants during the four-week period between study visits querying minutes of exercise.
This is reported as average minutes/day on exercise days.
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Study B only: Daily for four weeks between baseline and second study visit
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Daily Only Survey of Fruit/Vegetable Consumption
Tidsramme: Study B only: Daily for four weeks between baseline and second study visit
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Daily surveys sent to Study B participants during the four-week period between study visits querying consumption of fruits and vegetables.
This is reported as average servings/day on fruit/vegetable consumption days.
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Study B only: Daily for four weeks between baseline and second study visit
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Daily Online Survey on Cannabis Use
Tidsramme: Study B only: Daily for four weeks between baseline and second study visit
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Daily surveys sent to Study B participants during the four-week period between study visits querying amount of cannabis used.
This is reported as average grams/cannabis use day.
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Study B only: Daily for four weeks between baseline and second study visit
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Bryan AD, Skrzynski CJ, Yang J, Chrystal KA, Bidwell LC, Hutchison KE, Perreault L. Inhaling high THC cannabis acutely increases inflammation but not insulin sensitivity: a quasi-randomized trial. Sci Rep. 2026 Jul 16. doi: 10.1038/s41598-026-62837-0. Online ahead of print.
- Skrzynski CJ, Bryan AD, Schmiege SJ. Quasi-randomization to Cannabinoid Condition in Studies of US Legal Market Cannabis: Characteristics of Accepters Versus Decliners of Condition Assignment. Prev Sci. 2026 Mar;27(3):441-450. doi: 10.1007/s11121-026-01893-4. Epub 2026 Mar 13.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
8. november 2019
Primær færdiggørelse (Faktiske)
1. december 2024
Studieafslutning (Faktiske)
1. december 2024
Datoer for studieregistrering
Først indsendt
6. september 2019
Først indsendt, der opfyldte QC-kriterier
1. oktober 2019
Først opslået (Faktiske)
3. oktober 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i det endokrine system
- Psykiske lidelser
- Ernæringsforstyrrelser
- Metaboliske sygdomme
- Overernæring
- Kropsvægt
- Glukosemetabolismeforstyrrelser
- Stof-relaterede lidelser
- Kemisk inducerede lidelser
- Hyperinsulinisme
- Overvægtig
- Patologiske tilstande, tegn og symptomer
- Ernæringsmæssige og metaboliske sygdomme
- Tegn og symptomer
- Fedme
- Diabetes mellitus, type 2
- Diabetes mellitus
- Misbrug af marihuana
- Insulin resistens
Andre undersøgelses-id-numre
- 1R01DA050515 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .