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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

Page last updated: August 23, 2015

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