Exploring the Anti-inflammatory Properties of Cannabis and Their Relevance to Insulin Sensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 233
- 试验地点
- 1
- 主要终点
- Markers of Inflammation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Study A
Adults balanced across the weight spectrum who have tried cannabis at least once with no negative reaction but are not regular users.
干预措施: Study A: Single use of cannabis flower product (Other)
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.
干预措施: Study B: Ad libitum cannabis use for four weeks or no cannabis use (Other)
结局指标
主要结局
Markers of Inflammation
时间窗: 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 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
Change in Matsuda Index of Insulin Sensitivity
时间窗: Study A: Baseline versus after acute use one week later of cannabis product. Study B: The two tests will be separated by four weeks
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.
Change in Plasma Glucose
时间窗: 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 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.
Change in Plasma Insulin
时间窗: Study A: Baseline versus one week later after acute use of cannabis product. Study B: Baseline versus four weeks later
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.
次要结局
- Stanford Seven-Day Physical Activity Recall (PAR)(Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline)
- Nutrition Data System for Research 24-Hour Dietary Recall(Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline)
- Stanford Leisure-Time Activity Categorical Item (L-Cat)(Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline)
- Sleep Quality(Study A: Baseline only Study B: Baseline to four weeks following baseline)
- Marijuana Consumption Questionnaire(Study A: Baseline only. Study B: Baseline and four weeks following baseline)
- Marijuana Dependence Scale(Study A: Baseline only. Study B: Baseline and four weeks following baseline)
- Marijuana Withdrawal Checklist(Study A: Assessed at follow-up, one week following baseline. Study B: Assessed at follow-up, four weeks following baseline.)
- The Alcohol Use Disorder Identification Test (AUDIT)(Study A: Baseline only. Study B: Baseline and four weeks following baseline)
- Timeline Follow-Back of Substance Use(Study A: Baseline only. Study B: Baseline and four weeks following baseline)
- SF-12 Health Survey(Study A: Baseline only. Study B: Baseline and four weeks following baseline)
研究者
Angela Bryan
PI
University of Colorado, Boulder