The Role of Endocannabinoids in Insulin Production and Action
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 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.
Timeline
- Start
- 2012-01-05
- Primary completion
- 2014-10-06
- Completion
- 2014-10-06
Publications
- Background Pratley RE, Weyer C. The role of impaired early insulin secretion in the pathogenesis of Type II diabetes mellitus. Diabetologia. 2001 Aug;44(8):929-45. doi: 10.1007/s001250100580.
- Background Straub SG, Sharp GW. Hypothesis: one rate-limiting step controls the magnitude of both phases of glucose-stimulated insulin secretion. Am J Physiol Cell Physiol. 2004 Sep;287(3):C565-71. doi: 10.1152/ajpcell.00079.2004.
- Background Elahi D, Muller DC, McAloon-Dyke M, Tobin JD, Andres R. The effect of age on insulin response and glucose utilization during four hyperglycemic plateaus. Exp Gerontol. 1993 Jul-Oct;28(4-5):393-409. doi: 10.1016/0531-5565(93)90066-m.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OTENABANT | Small molecule | 15 mg | — |
| Subject | OTENABANT | Small molecule | 45 mg | — |
Indications
No indication recorded.