Insulin Resistance Clinical Trial
Official title:
Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Haloperidol in Healthy Humans
NCT number | NCT00625014 |
Other study ID # | P05.009 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2005 |
Est. completion date | July 2005 |
Verified date | August 2019 |
Source | Leiden University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
We hypothesized that short-term treatment with haloperidol induces insulin resistance through a mechanistic route that is independent of weight gain. We therefore treated healthy non-obese men with haloperidol for 8 days, and studied the impact of these intervention on glucose and lipid metabolism by hyperinsulinemic euglycemic clamp, isotope dilution technology and indirect calorimetry.
Status | Completed |
Enrollment | 8 |
Est. completion date | July 2005 |
Est. primary completion date | July 2005 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Healthy men - 20 kg/m2 < BMI < 26 kg/m2 - Age 20-40 years - FPG < 6 mmol/L Exclusion Criteria: - FPG > 6 mmol/L - BMI > 26 kg/m2 - Psychiatric disorders and/or use of antipsychotic or antidepressants drugs at present or in the past. - A positive family history of schizophrenia - Any significant chronic disease - Renal, hepatic or endocrine disease - Use of medication known to influence lipolysis and/or glucose metabolism - Total cholesterol > 7mmol/L and/or triglycerides > 2 mmol/L - Recent weight changes or attempts to loose weight (> 3 kg weight gain or loss, within the last 3 months) - Difficulties to insert an intravenous catheter - Smoking (current) - Severe claustrophobia (ventilated hood) - Recent blood donation (within the last 2 months) - Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year - Extensive sporting activities (more than 10 hours of exercise per week) |
Country | Name | City | State |
---|---|---|---|
Netherlands | Leiden University Medical Center | Leiden |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center | Dutch Diabetes Research Foundation |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the effect of subchronic haloperidol treatment on HGO, whole body peripheral glucose disposal, fatty acid flux and fuel oxidation. | 8 days |
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