NCT05322213

THC Effects on Glucose in Type 2 Diabetes

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	THC	2-Week, once daily, flexible dose, inhaled THC
DRUG	Placebo	2-Week, once daily, flexible dose, inhaled placebo

Timeline

• Start date: 2024-08-22
• Primary completion: 2027-12-01
• Completion: 2028-06-01
• First posted: 2022-04-11
• Last updated: 2025-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study