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RecruitingNCT05322213Updated Jun 15, 2026

THC Effects on Glucose in Type 2 Diabetes

A Phase 1 interventional study of THC and Placebo in Type 2 Diabetes, sponsored by University of California, San Diego. Recruiting at 1 site in United States. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by University of California, San Diego · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Started Aug 2024; still recruiting 2 years 1 month later.
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
21 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Type 2 Diabetes

Keywords

  • THC
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's planned enrollment of 30 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Active THC

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

    Drug: THC · Drug: Placebo

  • Placebo comparator
    Placebo Cannabis

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

    Drug: THC · Drug: Placebo

Interventions

  • DrugTHC

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

    Also known as: Cannabis

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Change in Glucose Disposal Rate

    The change in glucose uptake from placebo treatment to THC treatment as measure by the hyperinsulinemic/euglycemic clamp.

    Time frame: 6 weeks

  2. Change in Vascular Endothelial Function

    The change in vascular endothelial function from placebo treatment to THC treatment as measured by reactive hyperemia-peripheral arterial tonometry (reactive hyperemia index).

    Time frame: 6 weeks

07

Study locations

1 of 1 sites recruiting
  • UC San Diego Altman Clinical & Translational Research Institute
    La Jolla, California 92037, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05322213
Lead sponsor
University of California, San Diego
Collaborators
Center for Medicinal Cannabis Research
Responsible party
Jeremy Pettus, MD (Principal Investigator, University of California, San Diego) — Principal investigator
First posted
Apr 11, 2022
Start date
Aug 22, 2024
Primary completion
Dec 2027 (estimated)
Completion
Jun 2028 (estimated)
Last update
Jun 15, 2026

Study contacts

Todd May, MS
Contact
tmay@health.ucsd.edu
858-246-2169

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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