THC Effects on Glucose in Type 2 Diabetes

ConditionType 2 Diabetes

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age21-70

SponsorUniversity of California, San Diego

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

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

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Active THCActive comparator 2 interventions

Group B: Placebo CannabisPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Diego

Lead sponsor

Center for Medicinal Cannabis Research

Collaborator

Source ClinicalTrials.gov

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