thc effects on glucose in type 2 diabetes

Conditions: 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.

a single-center, double-blind, placebo-controlled, cross-over study designed to evaluate the effects of thc on glucose metabolism and endothelial functioning in individuals with type 2 diabetes. to accomplish the specific aims proposed, a single clinical trial will be conducted in which a maximum of 30 subjects with t2d, who are otherwise healthy, will be treated with thc and matching placebo in a cross-over study design. each treatment period will be 2 weeks in duration with metabolic and endothelial assessments done post-therapy. subjects will be randomized on a 1:1 basis to either receive either thc or placebo for the first 2 weeks of therapy. then following a 4-week washout, they will receive the opposite investigational product for the second 2 weeks of therapy. subjects will remain on their standard treatment for t2d throughout the entire course of the study. there will be a total of 10 study visits and subjects will be enrolled for approximately 16 weeks. 1. screening - complete consenting process, complete medical history and physical exam, review of current medications, collect height/weight, vital signs, ecg and fasting laboratory (blood and urine) tests. 2. visit 2 - treatment session 1 start - collect weight, vital signs and fasting laboratory tests. receive investigational product and training on its use. 3. visit 3 - monitory investigational product compliance and adjust dosing. 4. visit 4 - complete endothelial function tests including flow mediated dilation and endopat, complete vital signs, weight and laboratory tests for safety. 5. visit 5 - complete a 2-step hyperinsulinemic/euglycemic clamp and indirect calorimetry. begin 4-week washout. 6. visit 6 - treatment session 2 start - collect weight, vital signs and receive investigational product and training on its use. 7. visit 7 - monitory investigational product compliance and adjust dosing. 8. visit 8 - complete endothelial function tests including flow mediated dilation and endopat, complete vital signs, weight and laboratory tests for safety. 9. visit 9 - complete a 2-step hyperinsulinemic/euglycemic clamp and indirect calorimetry. discontinue use of investigational product. 10. safety follow-up - collect weight, vital signs, ecg and fasting laboratory tests. receive investigational product and training on its use.

Eligibility criteria:
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.

Keywords: thc