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THC Effects on Glucose in Type 2 Diabetes

RecruitingPhase 1Ages 21 Years - 70 YearsAllUniversity of California, San Diego
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In plain words

What the trial is, and whether it could suit you

This study will examine the effects THC has on Glucose Metabolism and Endothelial Functioning in participants with Type 2 Diabetes. The participants will complete blood tests and tests to measure energy expenditure, CVD risks, and glucose metabolism. These tests will be performed prior to start of treatment and again after 2-weeks of treatment with the THC or placebo.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Males and Females 21-70 years old at the time of screening. * Females of non-child bearing potential must be โ‰ฅ 1 year post-menopausal or documented as being surgically sterile. Females of child bearing potential must agree to use two methods of contraception during the entire study. * Male subjects must be willing to use clinically acceptable method of contraception during the entire study. * Have a clinical diagnosis of Type 2 Diabetes on a stable medication regimen for at least 3 months. * BMI \> 25 kg/m2). * HbA1c \< 10%). * Negative urine toxicology result at screening visit. * Able to provide written informed consent approved by an Institutional Review Board (IRB). Exclusion Criteria: * History or presence of any clinically significant illness, as detected by history, physical examination, and/or laboratory tests, that might put the participant at increased risk of adverse events (e.g., history of psychotic disorder, clinically significant mood and/or anxiety disorder, liver, or renal disease). * No prior history of myocardial infarction, stroke or heart failure. * Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening. Donations of plasma, packed RBCs, platelets or quantities less than 500 mL are allowed at investigator discretion. * Hemoglobin \< 9g/dL. * Liver enzymes โ‰ฅ 2 times upper normal limit and/or clinical signs/symptoms consistent with liver disease, including but not limited to nausea, vomiting, jaundice, itching, abdominal pain, or edema. * History of clinically significant adverse events associated with cannabis intoxication (e.g., severe anxiety and panic, paranoia and psychosis, sustained tachycardia, or severe hypotension). * History of seizures, head trauma, or other history of CNS insult that could predispose the participant to seizures. * Use of any THC containing products within 30 days prior to the screening visit. * Current use of tobacco products. * Individuals who are pregnant or lactating/breastfeeding. * Current use of insulin to treat Type 2 Diabetes. * Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits. * Any other condition(s) that might reduce the chance of obtaining study data, or that might cause safety concerns, or that might compromise the ability to give truly informed consent.
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What it tests

  • THC
  • Placebo
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Where

1 site
UC San Diego Altman Clinical & Translational Research Institute
La Jolla, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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