Effects of THC on glucose metabolism in Type 2 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.