Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Antipsychotic Drugs in Healthy Humans
Information source: Leiden University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insulin Resistance; Dyslipidemia
Intervention: olanzapine (Drug); Haloperidol (Drug)
Phase: N/A
Status: Completed
Sponsored by: Leiden University Medical Center Official(s) and/or principal investigator(s):
Hanno Pijl, Phd MD, Study Chair, Affiliation: Leiden University Medical Center
Summary
We hypothesized that short-term treatment with AP drugs induces insulin resistance through a
mechanistic route that is independent of weight gain and that atypical drugs exert stronger
effects than typical compounds in this respect. We therefore treated healthy non-obese men
with olanzapine (atypical AP) or haloperidol (typical AP) for 8 days, and studied the impact
of these interventions on glucose and lipid metabolism by hyperinsulinemic euglycemic clamp,
isotope dilution technology and indirect calorimetry.
Clinical Details
Official title: Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Antipsychotic Drugs in Healthy Humans
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
Primary outcome: To determine the effect of subchronic olanzapine and haloperidol treatment on HGO, whole body peripheral glucose disposal, fatty acid flux and fuel oxidation.
Eligibility
Minimum age: 20 Years.
Maximum age: 40 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Healthy men, with and without a positive family history of schizophrenia.
- 20 kg/m2 < BMI < 26 kg/m2
- Age 20-40 years
- Fasting plasma glucose < 6 mmo/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.
- 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)
Locations and Contacts
Leiden University Medical Center, Leiden 2300 RC, Netherlands
Additional Information
Starting date: May 2004
Last updated: February 19, 2008
|
