THC Effects on Glucose in Type 2 Diabetes

NCT05322213 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 802153
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

THC

Outcome Measures

Primary Outcomes (3)

• Change in Glucose Uptake

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

  6 weeks

• Change in Vascular Endothelial Function

  The change in vascular endothelial function from placebo treatment to THC treatment as measured by flow mediated dilation (brachial artery diameter).

  6 weeks

• 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).

  6 weeks

Study Arms (2)

Active THC

ACTIVE COMPARATOR

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

Drug: THC; Drug: Placebo

Placebo Cannabis

PLACEBO COMPARATOR

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

Drug: THC; Drug: Placebo

Interventions

THC DRUG

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

Also known as: Cannabis

Active THC; Placebo Cannabis

Placebo DRUG

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

Active THC; Placebo Cannabis

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• Center for Medicinal Cannabis Research: collaborator

Study Sites (1)

UC San Diego Altman Clinical & Translational Research Institute

La Jolla, California, 92037, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Dronabinol; nabiximols

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Central Study Contacts

Todd May, MS

CONTACT

858-246-2169; tmay@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single-Center, double-blind, placebo-controlled, crossover study.

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 11, 2022
• Study Start: August 22, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)