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THC Effects on Glucose in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT05322213
Recruitment Status : Not yet recruiting
First Posted : April 11, 2022
Last Update Posted : January 25, 2023
Sponsor:
Collaborator:
Center for Medicinal Cannabis Research
Information provided by (Responsible Party):
Jeremy Pettus, MD, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE March 30, 2022
First Posted Date  ICMJE April 11, 2022
Last Update Posted Date January 25, 2023
Estimated Study Start Date  ICMJE May 1, 2023
Estimated Primary Completion Date April 30, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2022)
  • 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.
  • 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).
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE THC Effects on Glucose in Type 2 Diabetes
Official Title  ICMJE The Effects of THC on Glucose Metabolism and Endothelial Function in Subjects With Type 2 Diabetes
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: THC
    2-Week, once daily, flexible dose, inhaled THC
    Other Name: Cannabis
  • Drug: Placebo
    2-Week, once daily, flexible dose, inhaled placebo
Study Arms  ICMJE
  • Active Comparator: Active THC
    Daily, inhaled, flexible dose of cannabis product with THC.
    Interventions:
    • Drug: THC
    • Drug: Placebo
  • Placebo Comparator: Placebo Cannabis
    Daily, inhaled, flexible dose of cannabis product without THC.
    Interventions:
    • Drug: THC
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 8, 2022)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2027
Estimated Primary Completion Date April 30, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Todd May, MS 858-246-2169 tmay@health.ucsd.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05322213
Other Study ID Numbers  ICMJE 802153
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Jeremy Pettus, MD, University of California, San Diego
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, San Diego
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Center for Medicinal Cannabis Research
Investigators  ICMJE Not Provided
PRS Account University of California, San Diego
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP