Status:
COMPLETED
The Role of Endocannabinoids in Insulin Production and Action
Lead Sponsor:
National Institute on Aging (NIA)
Conditions:
Healthy Volunteers
Eligibility:
All Genders
21-55 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
Objectives and Specific Aims: We plan to investigate whether the endocannabinoid system is involved in the regulation of insulin secretion from Beta cells and in the modulation of insulin action in p...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Healthy men only
- (We want to study men because the magnitude of acute insulin response for men and women is different. In addition, as women may become pregnant in the course of the study, and since this is a physiology study only, and not one related to treatments, we want to remove any confounders and lessen any chance of drop-out.)
- Age 21-55 (Age restriction is used to remove age as a confounding factor because Beta cells function tends to deteriorate and first phase secretion becomes less defined with age.
- Screening laboratory evaluations with no clinically significant abnormal results (minor deviations from normal lab results will be at the discretion of the principal investigator):
- fasting comprehensive metabolic panel
- complete blood count with differential and platelet
- thyroid function test (TSH, free T4)
- urinalysis
- urine drug screen
- BMI less than 30 (Men with BMI greater than or equal to 30 are excluded because obesity has been associated with altered beta cell function.
- Have NOT participated in another clinical trial involving any pharmacologic agents within the past 30 days
- Able to complete an inform consent
- Agree to not participate in other clinical trials within the study period (at the discretion of the study investigator)
- EXCLUSION CRITERIA:
- 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
Exclusion
Key Trial Info
Start Date :
January 5 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2014
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01517100
Start Date
January 5 2012
End Date
October 6 2014
Last Update
January 9 2026
Active Locations (1)
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1
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, United States, 21224