Clinical trial NCT04114903: Exploring the Anti-inflammatory Properties of Cannabis and Their Relevance to Insulin Sensitivity
Official title: Exploring the Anti-inflammatory Properties of Cannabis and Their Relevance to Insulin Sensitivity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Obesity
Cannabis Use
Insulin Sensitivity
Keywords: Diabetes
Obesity
Cannabis
Insulin Sensitivity
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
First posted: 2019-10-03
Enrollment: 255
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community Sample

Brief summary: This study tests the effects of cannabinoid levels in blood on inflammation and insulin sensitivity both acutely and chronically in individuals across the weight spectrum. To that end, the study employs two observational designs: 1) A study of acute effects with intermittent cannabis users and 2) A study in which current cannabis users will select one of three cannabis strains for four weeks and are compared to a matched control group who do not use cannabis to study chronic effects. Blood levels of THC and CBD, inflammatory biomarkers, and insulin resistance will be measured in both studies.

Detailed description: According to the National Institute of Diabetes and Digestive and Kidney Diseases, over 30 million people in the US have diabetes, and just over 84 million people have pre-diabetes. Concurrently, 30 states and the District of Columbia have legalized cannabis for medical and/or recreational use and over the past decade, cannabis use among adults has more than doubled.

Public perception and some scientific data suggest that cannabis causes acute over-eating, creating concern that public and legal acceptance of cannabis use will worsen the obesity epidemic in the United States, where more than two-thirds of US adults (68.8%) are currently overweight or obese. Paradoxically, cross sectional data demonstrate associations between chronic cannabis use and lower body mass index (BMI), prevalence of obesity, insulin resistance, waist circumference, and actual rates of type 2 diabetes despite data supporting higher caloric intake acutely.

This study examines the effects of cannabinoid levels in blood on inflammation and insulin sensitivity both acutely and chronically in individuals across the weight spectrum. To that end, the study employs two observational designs: 1) A study of acute effects with intermittent cannabis users and 2) A study in which current cannabis users will select one of three cannabis strains for four weeks and are compared to a matched control group who do not use cannabis to study chronic effects.

Eligibility criteria: Inclusion Criteria:

* Able to provide informed consent
* Cannabis users in Study A must have smoked or vaped cannabis at least once since January 1st 2014 with no negative effects but NOT used in the past three months
* Cannabis users in Study B must have been a regular (at least weekly) user for at least a year
* Non-users in Study B cannot have used any cannabis in the previous year
* Weight stable (\<5 pound fluctuation in the past six months)
* Planning to remain in the Boulder-Denver area for the next month
* Fasting blood glucose greater than or equal to 55 mg/dl and less than or equal to 126 mg/dl
* Cannabis users in Study A must endorse knowledge of the procedure(s) for smoking or vaping cannabis

Exclusion Criteria:

* Known auto-immune disease
* Report of other drug use (cocaine, opiates, methamphetamine) in the past 90 days or fail urine screen for any of these drugs
* Daily tobacco (cigarette, E-cigs, smokeless) user, given the impact of tobacco smoking on insulin function
* Blood alcohol level greater than 0 at screening
* Current use of medications for glucose lowering, immunosuppression, or anti-inflammation
* Acute illness
* Current use of psychotropic medications
* Current diagnosis of diabetes
* Heavy drinking as defined by an Alcohol Use Disorders Test (AUDIT)
* Females can not be pregnant or trying to become pregnant
* Females can not be nursing mothers
* Have donated blood in the 8 weeks before the study or intend to donate blood in the 8 weeks after the study.

Primary outcomes:
measure: Markers of Inflammation
timeFrame: 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
measure: Change in Matsuda Index of Insulin Sensitivity
timeFrame: Study A: Baseline versus after acute use one week later of cannabis product. Study B: The two tests will be separated by four weeks
measure: Change in Plasma Glucose
timeFrame: Study A: Baseline versus one week later after acute use of cannabis product. Study B: The two tests will be separated by four weeks
measure: Change in Plasma Insulin
timeFrame: Study A: Baseline versus one week later after acute use of cannabis product. Study B: The two tests will be separated by four weeks
Secondary outcomes:
measure: Stanford Seven-Day Physical Activity Recall (PAR)
timeFrame: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
measure: Sleep Quality
timeFrame: Study A: Baseline to one week following baseline Study B: Baseline to four weeks following baseline
measure: Marijuana Consumption Questionnaire
timeFrame: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
measure: Marijuana Dependence Scale
timeFrame: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
measure: Marijuana Withdrawal Checklist
timeFrame: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
measure: The Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
measure: Timeline Follow-Back of Substance Use
timeFrame: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
measure: SF-12 Health Survey
timeFrame: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
measure: Nutrition Data System for Research 24-Hour Dietary Recall
timeFrame: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
measure: Stanford Leisure-Time Activity Categorical Item (L-Cat)
timeFrame: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
Other outcomes:
measure: Daily online survey of cannabis use, alcohol use, exercise and diet
timeFrame: Study B only: Daily for four weeks between baseline and second study visit
Locations:
city: Boulder
country: United States
facility: Center for Innovation and Creativity
state: Colorado
Study officials:
References: