The Role of Endocannabinoids in Insulin Production and Action
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
Background: \- The endocannabinoid system is involved in different body functions and processes. It helps regulate appetite and mood, and sends signals to the nervous system. It may also be involved in how the body produces insulin during digestion. Researchers want to test two drugs that work on the endocannabinoid system: nabilone and CP-945,598. These drugs may be able to affect insulin levels in the blood. This information may suggest possible new treatments for people with diabetes. Objectives: \- To study how the endocannabinoid system is involved in insulin production and action. Eligibility: \- Healthy men between 21 and 55 years of age. Design: * Participants will be screened with a physical exam and medical history. They will provide blood and urine samples. They will also have imaging studies to test their brain responses, especially to food-related cues. Some participants will also have a study visit to test their insulin resistance levels. * Participants will have four separate study visits 6 weeks apart. They will keep a food diary before each visit. At each visit, they will have one of the following combinations of drugs: * Double placebo * Placebo and nabilone * Placebo and low dose of CP-945,598 * Placebo and high dose of CP-945,598. * Participants will have follow-up visits 1 week after each study visit. Blood samples will be taken.
Key facts
- Study ID
- NCT01517100
- Run by
- National Institute on Aging (NIA)
- People needed
- 45
- Starts
- 2012-01-05
- Expected to finish
- 2014-10-06
- Last updated by the study team
- 2026-08-07
Who can join
Age: 21 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Women
- FPG greater than or equal to 100 mg/dl or 2-hr OGTT greater than or equal to 140 mg/dL
- Evidence of illicit drug use
- History of substance abuse including marijuana within the past 6 months
- History of smoking any tobacco products within six months prior to screening
- Alcohol intake greater than 30 grams (drink more than 2 beers per day OR equivalent amount of alcohol)
- History of Human Immunodeficiency Virus (HIV) infection
- History of active or chronic Hepatitis B and/or C infection
- History of malignancy
- History of coronary disease
- History of seizures or other neurologic diseases
- History of psychiatric illnesses including major depressive disorder, schizophrenia, bipolar disorder
- Any lifetime history of suicide attempt
- History of suicidal behavior in the last year
- Any suicidal behavior during any follow-up visits
- History of any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale
- (C-SSRS) in the last year
- Any suicidal ideation of type 4 or 5 on the C-SSRS during any follow-up visits.
- Patient Health Questionnaire-9 (PHQ-9) score greater than or equal to 10 during screening visit or any follow-up study visits
- Generalized Anxiety Disorder-7 (GAD-7) score greater than or equal to 10 during screening visit or any follow-up visits
- History of liver or renal diseases
- History of gastrointestinal or endocrine disorders
- History of glucocorticoid use (over one month) or other immunosuppressive agents (any)
- Any condition or non-removable device contraindicated for MRI (pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments, or history of working as a welders or metal worker)
- Any medical history that, in the opinion of the investigator(s), will make participation of the subject in the study unsafe
Where it is running
- National Institute of Aging, Clinical Research Unit — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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