Exploring the Anti-inflammatory Properties of Cannabis and Their Relevance to Insulin Sensitivity (SONIC)

University of Colorado Boulder (CU)

Status: Completed

Conditions: Cannabis Use; Obesity; Type 2 Diabetes; Insulin Sensitivity

Treatments: Other: Study A: Single use of cannabis flower product; Other: Study B: Ad libitum cannabis use for four weeks or no cannabis use

Study type: Observational

Funder types: Other

Identifiers

NCT04114903

1R01DA050515

Details and patient eligibility

About

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.

Full 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.

Enrollment: 255 patients

Sex: All

Ages: 21 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

255 participants in 2 patient groups

Study A

Description:

Adults balanced across the weight spectrum who have tried cannabis at least once with no negative reaction but are not regular users.

Treatment:

Other: Study A: Single use of cannabis flower product

Study B

Description:

Sample of current cannabis users and non-users balanced across the weight spectrum who are matched on age, gender, BMI and physical activity.

Treatment:

Other: Study B: Ad libitum cannabis use for four weeks or no cannabis use