Effects of THC on glucose metabolism in Type 2 Diabetes
The Effects of THC on Glucose Metabolism and Endothelial Function in Subjects With Type 2 Diabetes
PHASE1 · University of California, San Diego · NCT05322213
This study is testing whether THC can improve how the body processes sugar and supports heart health in people with Type 2 Diabetes.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 21 Years to 70 Years |
| Sex | All |
| Sponsor | University of California, San Diego (other) |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT05322213 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates how THC influences glucose metabolism and endothelial function in individuals diagnosed with Type 2 Diabetes. It employs a single-center, double-blind, placebo-controlled, cross-over design involving 30 participants who will receive either THC or a placebo over two-week treatment periods, separated by a four-week washout. Participants will undergo various assessments, including blood tests and evaluations of cardiovascular risks and energy expenditure, both before and after treatment. The study aims to provide insights into the metabolic effects of THC in this patient population.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 21-70 with a stable Type 2 Diabetes diagnosis and a BMI over 25.
Not a fit: Patients with significant comorbid conditions or those with a history of psychotic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new therapeutic approaches for managing glucose levels in patients with Type 2 Diabetes.
How similar studies have performed: While studies on THC's effects on various health conditions exist, this specific approach to glucose metabolism in Type 2 Diabetes is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
La Jolla, California
- UC San Diego Altman Clinical & Translational Research Institute — La Jolla, California, United States (RECRUITING)
Study contacts
- Study coordinator: Todd May, MS
- Email: tmay@health.ucsd.edu
- Phone: 858-246-2169
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes, THC