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Trial record 5 of 18 for:    marijuana | Recruiting, Not yet recruiting, Active, not recruiting, Enrolling by invitation Studies | ( Map: Colorado, United States )

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

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ClinicalTrials.gov Identifier: NCT04114903
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : October 28, 2019
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by (Responsible Party):
Angela Bryan, University of Colorado, Boulder

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.

Condition or disease
Type 2 Diabetes Obesity Cannabis Use Insulin Sensitivity

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.


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Study Type : Observational
Estimated Enrollment : 214 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Exploring the Anti-inflammatory Properties of Cannabis and Their Relevance to Insulin Sensitivity
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Marijuana
Drug Information available for: Insulin

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



Primary Outcome Measures :
  1. Markers of Inflammation [ Time Frame: 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-1B, IL-4, IL-6, IL-10, IL-13, MCP-1)

  2. Change in Matsuda Index of Insulin Sensitivity [ Time Frame: 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)

    Matsuda Index is calculated as follows: 10000/sqrt ((FPG X FPI) X (Mean OGTT glucose concentration X Mean OGTT insulin concentration))


  3. Change in Plasma Glucose [ Time Frame: 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.

  4. Change in Plasma Insulin [ Time Frame: 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 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.


Secondary Outcome Measures :
  1. Stanford Seven-Day Physical Activity Recall (PAR) [ Time Frame: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline ]
    Interviewer administered assessment of number of minutes of mild, moderate, and vigorous physical activity over the previous seven days.

  2. Sleep Quality [ Time Frame: Study A: Baseline to one week following baseline Study B: Baseline to four weeks following baseline ]
    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.

  3. Marijuana Consumption Questionnaire [ Time Frame: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline ]
    Frequency and quantity of cannabis use, age of first use, peer use, perceived risk from cannabis, and perceived availability of cannabis

  4. Marijuana Dependence Scale [ Time Frame: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline ]
    Based on DSM V criteria that were converted to a self-report to assess dependence and other problems related to the use of cannabis

  5. Marijuana Withdrawal Checklist [ Time Frame: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline ]
    A 15-item scale used to collect information on withdrawal symptoms participants may be experiencing due to lack of use of marijuana

  6. The Alcohol Use Disorder Identification Test (AUDIT) [ Time Frame: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline ]
    Standardized assessment of the extent of alcohol use and problems related to alcohol use

  7. Timeline Follow-Back of Substance Use [ Time Frame: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline ]
    Calendar-based assessment of daily substance use for the 30 days prior to the baseline session only for both studies

  8. SF-12 Health Survey [ Time Frame: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline ]
    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

  9. Nutrition Data System for Research 24-Hour Dietary Recall [ Time Frame: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline ]
    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

  10. Stanford Leisure-Time Activity Categorical Item (L-Cat) [ Time Frame: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline ]
    Self-report measure of a single item comprising six descriptive categories ranging from inactive to very active


Other Outcome Measures:
  1. Daily online survey of cannabis use, alcohol use, exercise and diet [ Time Frame: Study B only: Daily for four weeks between baseline and second study visit ]
    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


Biospecimen Retention:   Samples Without DNA
Blood samples collected for insulin sensitivity, inflammation markers, and cannabinoid quantitation


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Community Sample
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04114903


Contacts
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Contact: Gregory Giordano, MS 303-492-9549 sonic.custudy@gmail.com

Locations
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United States, Colorado
Center for Innovation and Creativity Recruiting
Boulder, Colorado, United States, 80301
Contact: Gregory Giordano, MS    303-492-9549      
Principal Investigator: Angela Bryan, PhD         
Sponsors and Collaborators
University of Colorado, Boulder
University of Colorado, Denver

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Responsible Party: Angela Bryan, Professor, University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT04114903     History of Changes
Other Study ID Numbers: 19-0015
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Angela Bryan, University of Colorado, Boulder:
Diabetes
Obesity
Cannabis
Insulin Sensitivity
Additional relevant MeSH terms:
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Marijuana Abuse
Insulin Resistance
Hypersensitivity
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Insulin
Anti-Inflammatory Agents
Hypoglycemic Agents
Physiological Effects of Drugs