THC Effects on Glucose in Type 2 Diabetes
The Effects of THC on Glucose Metabolism and Endothelial Function in Subjects With Type 2 Diabetes
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 21 Years to 70 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 10 visits
- Time periods mentioned: 16 weeks
- Procedures mentioned: Blood draws, Heart tracing (ECG), Physical exams
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The participants will complete blood tests and tests to measure energy expenditure, CVD risks, and glucose metabolism."
- "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."
- "Safety Follow-up - Collect weight, vital signs, ECG and fasting laboratory tests."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how THC affects blood sugar use and how well blood vessels work in adults with type 2 diabetes. Participants will have blood and other tests before treatment and after 2 weeks of THC or a placebo (a treatment with no active drug).
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 21 to 70 years old.
- Women who can become pregnant must use two birth control methods throughout the study. Other women must have had surgery that prevents pregnancy or have been past menopause for at least 1 year.
- Men must agree to use an accepted birth control method throughout the study.
- Have type 2 diabetes and have been on a stable medicine plan for at least 3 months.
- Have a BMI (a measure of weight compared with height) above 25.
- Have an HbA1c (a blood test showing average blood sugar) below 10%.
- Have a negative urine drug test at screening.
- Be able to give written consent to join the study.
Who can't join
- Have a major illness that could make the study unsafe, such as serious mental health, kidney, or liver disease. Liver test levels at least twice the upper normal limit or signs of liver disease also rule you out.
- Have a history of heart attack, stroke, or heart failure.
- Donated 1 pint (500 mL) of whole blood within 8 weeks before screening, or have hemoglobin below 9 g/dL (low levels of the protein that carries oxygen in blood). Study staff may allow smaller donations or donations of blood parts.
- Have had a serious reaction to cannabis, such as severe panic, loss of touch with reality, a lasting fast heartbeat, or very low blood pressure. A history of seizures or brain injury that raises seizure risk also rules you out.
- Used any THC product within 30 days before screening, or currently use tobacco.
- Are pregnant or breastfeeding.
- Currently use insulin to treat type 2 diabetes.
- Cannot or will not follow study rules or attend visits, or have another condition that could affect safety, study results, or your ability to give informed consent.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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.
Study sites (1)
CA
- UC San Diego Altman Clinical & Translational Research Institute · La Jolla, CA 92037Todd May, MS · Study contact · t1dresearch@health.ucsd.eduJeremy Pettus, MD · Principal investigatorMore trials in La Jolla