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The Role of Endocannabinoids in Insulin Production and Action

NCT01517100 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-06-01

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

OTHER

Nabilone

CB agonist

DRUG

CP-945,598

Cannabinoid Receptor 1 antagonist

OTHER

hyperglycemic clamp

assesses beta cell response

OTHER

euglycemic-hyperinsulinemic clamp

measures insulin sensitivity

OTHER

Nabilone

cannabinoid receptor agonist

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    lead NIH

Principal Investigators

  • Chee W Chia, M.D. · National Institute on Aging (NIA)

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-05
Primary Completion
2014-10-06
Completion
2014-10-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01517100 on ClinicalTrials.gov