The Effects of THC on Glucose Metabolism and Endothelial Function in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Glucose Uptake
研究概览
简要总结
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.
详细描述
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.
- 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.
- Visit 2 - Treatment Session 1 Start - Collect weight, vital signs and fasting laboratory tests. Receive investigational product and training on its use.
- Visit 3 - Monitory investigational product compliance and adjust dosing.
- Visit 4 - Complete endothelial function tests including flow mediated dilation and EndoPat, complete vital signs, weight and laboratory tests for safety.
- Visit 5 - Complete a 2-Step Hyperinsulinemic/Euglycemic clamp and Indirect Calorimetry. Begin 4-week washout.
- Visit 6 - Treatment Session 2 Start - Collect weight, vital signs and receive investigational product and training on its use.
- Visit 7 - Monitory investigational product compliance and adjust dosing.
- Visit 8 - Complete endothelial function tests including flow mediated dilation and EndoPat, complete vital signs, weight and laboratory tests for safety.
- Visit 9 - Complete a 2-Step Hyperinsulinemic/Euglycemic clamp and Indirect Calorimetry. Discontinue use of investigational product.
- Safety Follow-up - Collect weight, vital signs, ECG and fasting laboratory tests. Receive investigational product and training on its use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Active THC
Daily, inhaled, flexible dose of cannabis product with THC.
干预措施: THC (Drug)
Active THC
Daily, inhaled, flexible dose of cannabis product with THC.
干预措施: Placebo (Drug)
Placebo Cannabis
Daily, inhaled, flexible dose of cannabis product without THC.
干预措施: THC (Drug)
Placebo Cannabis
Daily, inhaled, flexible dose of cannabis product without THC.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Glucose Uptake
时间窗: 6 weeks
The change in glucose uptake from placebo treatment to THC treatment as measure by the hyperinsulinemic/euglycemic clamp.
Change in Vascular Endothelial Function
时间窗: 6 weeks
The change in vascular endothelial function from placebo treatment to THC treatment as measured by reactive hyperemia-peripheral arterial tonometry (reactive hyperemia index).
次要结局
未报告次要终点
研究者
Jeremy Pettus, MD
Principal Investigator
University of California, San Diego