Status:
RECRUITING
THC Effects on Glucose in Type 2 Diabetes
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Center for Medicinal Cannabis Research
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
21-70 years
Phase:
PHASE1
Brief 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 ener...
Detailed Description
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 ac...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05322213
Start Date
August 22 2024
End Date
June 1 2028
Last Update
May 7 2025
Active Locations (1)
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1
UC San Diego Altman Clinical & Translational Research Institute
La Jolla, California, United States, 92037