RECRUITING

THC Effects on Glucose in Type 2 Diabetes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effects of THC on Glucose Metabolism and Endothelial Function in Subjects With Type 2 Diabetes

Quick Facts

Study Start:2024-08-22

Study Completion:2028-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05322213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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.

Inclusion Criteria

Exclusion 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).

* 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.

Contacts and Locations

Study Contact

Todd May, MS

CONTACT

858-246-2169

tmay@health.ucsd.edu

Study Locations (Sites)

UC San Diego Altman Clinical & Translational Research Institute

La Jolla, California, 92037

United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-22

Study Completion Date2028-06

Study Record Updates

Study Start Date2024-08-22

Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

Additional Relevant MeSH Terms

Type 2 Diabetes