THC Effects on Glucose in Type 2 Diabetes

Официальное название

The Effects of THC on Glucose Metabolism and Endothelial Function in Subjects With Type 2 Diabetes

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат THC
  2-Week, once daily, flexible dose, inhaled THC
• Препарат Placebo
  2-Week, once daily, flexible dose, inhaled placebo

Первичные конечные точки

• Change in Glucose Disposal Rate [Срок оценки: 6 weeks]
• Change in Vascular Endothelial Function [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• UC San Diego Altman Clinical & Translational Research Institute — La Jolla

Идентификаторы

NCT: NCT05322213 · 802153

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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