THC Effects on Glucose in Type 2 Diabetes

NCT ID: NCT05322213

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-22
• Study Completion Date: 2028-06-30

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 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.

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 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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Active THC

Daily, inhaled, flexible dose of cannabis product with THC.

Group Type: ACTIVE_COMPARATOR

THC

Intervention Type: DRUG

2-Week, once daily, flexible dose, inhaled THC

Placebo

Intervention Type: DRUG

2-Week, once daily, flexible dose, inhaled placebo

Placebo Cannabis

Daily, inhaled, flexible dose of cannabis product without THC.

Group Type: PLACEBO_COMPARATOR

THC

Intervention Type: DRUG

2-Week, once daily, flexible dose, inhaled THC

Placebo

Intervention Type: DRUG

2-Week, once daily, flexible dose, inhaled placebo

Interventions

THC

2-Week, once daily, flexible dose, inhaled THC

Intervention Type: DRUG

Placebo

2-Week, once daily, flexible dose, inhaled placebo

Intervention Type: DRUG

Other Intervention Names

Cannabis

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center for Medicinal Cannabis Research

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Jeremy Pettus, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UC San Diego Altman Clinical & Translational Research Institute

La Jolla, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Todd May, MS

Role: CONTACT

tmay@health.ucsd.edu

858-246-2169

Facility Contacts

Todd May, MS

Role: primary

t1dresearch@health.ucsd.edu

Other Identifiers

802153

Identifier Type: -

Identifier Source: org_study_id