THC for Type 2 Diabetes

Overseen By Todd May, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, San Diego

Must not be taking: Insulin, THC products

Disqualifiers: Psychotic disorder, Liver disease, others

Compensation: Varies

Number of Visits: 11

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how THC, a compound found in cannabis, affects glucose metabolism and blood vessel function in people with Type 2 Diabetes. The researchers will compare the effects of inhaled THC to a placebo over a two-week period. Participants will undergo various tests to measure sugar processing and assess heart health. Ideal candidates are those with Type 2 Diabetes who have been stable on their medications for at least three months and have a BMI over 25. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must have a stable medication regimen for at least 3 months before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that THC, the active component of cannabis, has been studied for its safety and effects on individuals with diabetes. Some studies suggest that medical cannabis might lower the risk of type 2 diabetes and help manage blood sugar levels. However, one study found that adults with type 1 diabetes who used cannabis faced a higher risk of diabetic ketoacidosis, a serious condition where the body produces too much acid in the blood.

Generally, people often tolerate THC well, but it can cause side effects like mood changes, dizziness, or fatigue. Since this trial is in an early stage, the main goal is to determine if THC is safe for individuals with type 2 diabetes. Researchers are still learning about how participants react to the treatment and what side effects might occur. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Type 2 Diabetes?

Researchers are excited about the potential of using THC to treat Type 2 Diabetes because it offers a novel approach compared to traditional treatments like metformin or insulin, which primarily focus on blood sugar control. THC, the active component of cannabis, may have anti-inflammatory and metabolic effects that address the underlying issues of insulin resistance and inflammation, common in Type 2 Diabetes. Unlike standard treatments, this innovative approach involves inhaling THC, possibly providing a quicker onset and more flexible dosing. By exploring THC's unique properties, researchers hope to discover a completely new way to manage and possibly improve the quality of life for people with Type 2 Diabetes.

What evidence suggests that THC might be an effective treatment for Type 2 Diabetes?

This trial will compare the effects of THC with a placebo in managing type 2 diabetes. Research has shown that medical cannabis, which contains THC, might help people with type 2 diabetes manage their blood sugar better. Some evidence suggests it could also lower the risk of developing type 2 diabetes. THC may help control how the body processes sugar, which is crucial for managing diabetes. However, more detailed studies are needed to fully understand its effects and safety. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Adults aged 21-70 with Type 2 Diabetes, a BMI over 25 kg/m2, and stable diabetes medication for at least 3 months can join. They must not use tobacco or THC products recently, have no significant illnesses or heart issues, and agree to contraception if of childbearing potential.

Inclusion Criteria

I am willing to use contraception throughout the study.

I agree to use two forms of birth control during the study.

I have been on stable diabetes medication for over 3 months.

Exclusion Criteria

You have experienced serious problems from using cannabis, such as extreme anxiety, paranoia, or severe changes in heart rate or blood pressure.

I have a history of conditions like seizures or head injuries that could make me more likely to have seizures.

I am willing and able to follow the study rules and attend all appointments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment Session 1

Participants receive either THC or placebo for 2 weeks with metabolic and endothelial assessments

2 weeks

4 visits (in-person)

Washout

Participants undergo a 4-week washout period before switching treatments

4 weeks

1 visit (in-person)

Treatment Session 2

Participants receive the opposite treatment (THC or placebo) for 2 weeks with metabolic and endothelial assessments

2 weeks

4 visits (in-person)

Safety Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• THC

Trial Overview The trial is testing the effects of THC on glucose metabolism in Type 2 Diabetes patients compared to a placebo. Participants will undergo blood tests and other assessments before and after two weeks of treatment to measure changes.

How Is the Trial Designed?

Group I: Active THC Active Control 2 Interventions

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

Group II: Placebo Cannabis Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Center for Medicinal Cannabis Research

Collaborator

Trials

19

Recruited

630+

Center For Medicinal Cannabis Research at UC San Diego Health

Collaborator

Trials

1

Recruited

30+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7433109/

The effects of recreational cannabis use on glycemic ... In one study of adults with T1D, cannabis use within the previous 12 months was associated with almost double the risk of diabetic ketoacidosis ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S104327602200162X

Cannabinoids and terpenes for diabetes mellitus and its ... While it has been suggested that peripheral blockade of CB1R may improve diabetes and diabetes-related complications, the use of synthetic CB1R antagonists has ...

3. diabetesjournals.org diabetesjournals.org/care/article/39/10/1777/129/Efficacy-and-Safety-of-Cannabidiol-and

Efficacy and Safety of Cannabidiol and ... This prompted the first-ever investigation of the effects of CBD and THCV on dyslipidemia and glycemic control in subjects with type 2 diabetes.

4. mdpi.com mdpi.com/2227-9059/13/10/2406

Long-Term Efficacy and Safety of Inhaled Cannabis ... Medical cannabis use leads to lower type 2 diabetes risk, along with better blood sugar management in patients, according to research observations that ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12011981/

The role of tetrahydrocannabivarin (THCV) in metabolic ... Furthermore, THCV's ability to enhance glucose regulation makes it particularly relevant to manage both obesity and type 2 diabetes [22].

6. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT05322213

THC Effects on Glucose in Type 2 Diabetes This study will examine the effects THC has on Glucose Metabolism and Endothelial Functioning in participants with Type 2 Diabetes.