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THC Effects on Glucose in Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05322213
Recruitment Status : Not yet recruiting
First Posted : April 11, 2022
Last Update Posted : April 11, 2022
Sponsor:
Collaborator:
Center For Medicinal Cannabis Research at UC San Diego Health
Information provided by (Responsible Party):
Jeremy Pettus, MD, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: THC Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Single-Center, double-blind, placebo-controlled, crossover study.
Masking: Double (Participant, Investigator)
Masking Description: Double-blind
Primary Purpose: Basic Science
Official Title: The Effects of THC on Glucose Metabolism and Endothelial Function in Subjects With Type 2 Diabetes
Estimated Study Start Date : August 1, 2022
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Active Comparator: Active THC
Daily, inhaled, flexible dose of cannabis product with THC.
Drug: THC
2-Week, once daily, flexible dose, inhaled THC
Other Name: Cannabis

Drug: Placebo
2-Week, once daily, flexible dose, inhaled placebo

Placebo Comparator: Placebo Cannabis
Daily, inhaled, flexible dose of cannabis product without THC.
Drug: THC
2-Week, once daily, flexible dose, inhaled THC
Other Name: Cannabis

Drug: Placebo
2-Week, once daily, flexible dose, inhaled placebo




Primary Outcome Measures :
  1. Change in Glucose Uptake [ Time Frame: 6 weeks ]
    The change in glucose uptake from placebo treatment to THC treatment as measure by the hyperinsulinemic/euglycemic clamp.

  2. Change in Vascular Endothelial Function [ Time Frame: 6 weeks ]
    The change in vascular endothelial function from placebo treatment to THC treatment as measured by flow mediated dilation (brachial artery diameter).

  3. Change in Vascular Endothelial Function [ Time Frame: 6 weeks ]
    The change in vascular endothelial function from placebo treatment to THC treatment as measured by reactive hyperemia-peripheral arterial tonometry (reactive hyperemia index).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05322213


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

Locations
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United States, California
UC San Diego Altman Clinical & Translational Research Institute
La Jolla, California, United States, 92037
Contact: Todd May, MS       tmay@health.ucsd.edu   
Principal Investigator: Jeremy Pettus, MD         
Sponsors and Collaborators
University of California, San Diego
Center For Medicinal Cannabis Research at UC San Diego Health
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Responsible Party: Jeremy Pettus, MD, Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT05322213    
Other Study ID Numbers: 802153
First Posted: April 11, 2022    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeremy Pettus, MD, University of California, San Diego:
THC
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases