THC Effects on Glucose in Type 2 Diabetes

Summary

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.

Eligibility

Inclusion Criteria:

* Males and Females 21-70 years old at the time of screening.
* Females of non-child bearing potential must be ≥ 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 ≥ 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.

Conditions2

Locations1 site

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