Effect of Short Term Atypical Antipsychotic Administration Compared to Placebo on Hepatic Insulin… (NCT02447835) | Clinical Trial Compass
CompletedPhase 1
Effect of Short Term Atypical Antipsychotic Administration Compared to Placebo on Hepatic Insulin Extraction
United States15 participantsStarted 2012-08
Plain-language summary
Within the past 20 years, there has been a striking increase in the incidence of obesity 1;2, type 2 diabetes mellitus (T2DM) 3-5, and cardiovascular diseases (CVD) in the schizophrenic population 6-8 . Large NIH-funded trials indicate that the prevalence of metabolic syndrome is twice to three times greater in schizophrenic patients on a specific class of drug termed the "atypical antipsychotics" (AAPs), of which olanzapine is an example, as compared to matched controls 8. Identification of the pathophysiological mechanisms contributing to metabolic disease in schizophrenic patients on AAPs has been hampered by the inability to differentiate underlying disease from treatment-emergent complications. In addition, despite falling within the same drug class, different AAPs exhibit differential associations with metabolic disease. Olanzapine is one of the AAPs associated with the greatest weight gain and degree of metabolic impairments.
Who can participate
Age range18 Years – 40 Years
SexALL
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Inclusion criteria
✓. Men and women ages 18-40
✓. BMI 19-24.5kg/m2
✓. Systolic BP \<130mm Hg
✓. Diastolic BP \<85mm Hg
✓. Subjects capable of giving informed consent, with no past or present psychiatric history
✓. Only women on oral contraceptives with constant dosing regimens or Depo-Provera for \>3 months, to ensure uniform hormonal delivery throughout the study duration
✓. No medications except as above noted
✓. Weight stable
Exclusion criteria
✕. History of heart disease, colitis, autonomic neuropathy, hepatic or renal disease
✕. DSM-IV diagnosis of past or present psychiatric history, including clinically significant depression
✕
What they're measuring
1
Determine the vagal contribution to the olanzapine-induced increase in circulating insulin levels.