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

NCT04114903 | Completed DMC

• 1 other identifier: 1R01DA050515
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Obesity; Cannabis Use; Insulin Sensitivity

Keywords

Diabetes; Obesity; Cannabis; Insulin Sensitivity

Outcome Measures

Primary Outcomes (4)

• Markers of Inflammation

  Change in Circulating Levels of Cytokines (TNF-α, 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

• 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

• 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

• 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 Outcomes (10)

• Stanford Seven-Day Physical Activity Recall (PAR)

  Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline

• Sleep Quality

  Study A: Baseline to one week following baseline Study B: Baseline to four weeks following baseline

• Marijuana Consumption Questionnaire

  Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline

• Marijuana Dependence Scale

  Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline

• Marijuana Withdrawal Checklist

  Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline

Other Outcomes (1)

• Daily online survey of cannabis use, alcohol use, exercise and diet

  Study B only: Daily for four weeks between baseline and second study visit

Study Arms (2)

Study A

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

Other: Study A: Single use of cannabis flower product

Study B

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

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

Interventions

Study A: Single use of cannabis flower product OTHER

Participants are asked to purchase and use one of three cannabis flower strains with differing levels of THC and CBD: 1) CBD (\~14% CBD/0% THC), 2) THC (\~14% THC/0% CBD), or 3) THC+CBD (\~7% THC/7% CBD).

Study A

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

Participants choose whether to use a cannabis flower product ad libitum for four weeks or to not use cannabis for four weeks. Participants who choose to use cannabis are asked to purchase and use one of three cannabis flower strains with differing levels of THC and CBD: 1) CBD (\~14% CBD/0% THC), 2) THC (\~14% THC/0% CBD), or 3) THC+CBD (\~7% THC/7% CBD).

Study B

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Community Sample

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Boulder: lead
• University of Colorado, Denver: collaborator

Study Sites (1)

Center for Innovation and Creativity

Boulder, Colorado, 80301, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples collected for insulin sensitivity, inflammation markers, and cannabinoid quantitation

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Insulin Resistance; Diabetes Mellitus; Marijuana Abuse

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: October 3, 2019
• Study Start: November 8, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)