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

Obesity Clinical Trial

— SONIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04114903
• Other study ID #: 1R01DA050515
• Status: Recruiting
• Start date: November 8, 2019
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2023
• Source: University of Colorado, Boulder
• Contact: Gregory Giordano, MS
• Phone: 303-492-9549
• Email: sonic.custudy[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Gender: All
• Age group: 21 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cannabis Use
• Hypersensitivity
• Insulin Resistance
• Insulin Sensitivity
• Marijuana Abuse
• Obesity
• Type 2 Diabetes

Locations

Country	Name	City	State
United States	Center for Innovation and Creativity	Boulder	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Boulder	University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Daily online survey of cannabis use, alcohol use, exercise and diet	Daily surveys sent to Study B participants during the four-week period between study visits querying for cannabis use, alcohol use, minutes of exercise, and consumption of fruits and vegetables	Study B only: Daily for four weeks between baseline and second study visit
Primary	Markers of Inflammation	Change in Circulating Levels of Cytokines (TNF-a, IL-1B, IL-4, IL-6, IL-10, IL-13, MCP-1)	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
Primary	Change in Matsuda Index of Insulin Sensitivity	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); Matsuda Index is calculated as follows: 10000/sqrt ((FPG X FPI) X (Mean OGTT glucose concentration X Mean OGTT insulin concentration))	Study A: Baseline versus after acute use one week later of cannabis product. Study B: The two tests will be separated by four weeks
Primary	Change in Plasma Glucose	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.	Study A: Baseline versus one week later after acute use of cannabis product. Study B: The two tests will be separated by four weeks
Primary	Change in Plasma Insulin	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.	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	Stanford Seven-Day Physical Activity Recall (PAR)	Interviewer administered assessment of number of minutes of mild, moderate, and vigorous physical activity over the previous seven days.	Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
Secondary	Sleep Quality	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.	Study A: Baseline to one week following baseline Study B: Baseline to four weeks following baseline
Secondary	Marijuana Consumption Questionnaire	Frequency and quantity of cannabis use, age of first use, peer use, perceived risk from cannabis, and perceived availability of cannabis	Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
Secondary	Marijuana Dependence Scale	Based on DSM V criteria that were converted to a self-report to assess dependence and other problems related to the use of cannabis	Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
Secondary	Marijuana Withdrawal Checklist	A 15-item scale used to collect information on withdrawal symptoms participants may be experiencing due to lack of use of marijuana	Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
Secondary	The Alcohol Use Disorder Identification Test (AUDIT)	Standardized assessment of the extent of alcohol use and problems related to alcohol use	Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
Secondary	Timeline Follow-Back of Substance Use	Calendar-based assessment of daily substance use for the 30 days prior to the baseline session only for both studies	Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
Secondary	SF-12 Health Survey	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	Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
Secondary	Nutrition Data System for Research 24-Hour Dietary Recall	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	Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
Secondary	Stanford Leisure-Time Activity Categorical Item (L-Cat)	Self-report measure of a single item comprising six descriptive categories ranging from inactive to very active	Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline