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Sponsors and Collaborators: |
National Health Research Institutes, Taiwan Taipei City Hospital Mackay Memorial Hospital Department of Health Yuli Hospital |
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Information provided by: | National Health Research Institutes, Taiwan |
ClinicalTrials.gov Identifier: | NCT00201292 |
Diabetes is prevalent in schizophrenics and may be induced by antipsychotic treatments. Several retrospective studies have suggested that psychiatric patients exposed to atypical antipsychotics may be at a higher risk for developing diabetes and ketoacidosis. The association between these atypical antipsychotics and the onset of diabetes is further strengthened by observations of:
The treatment emergent diabetes, along with other metabolic disturbances, represents a serious issue in the use of atypical antipsychotics. Major current debates and unresolved research issues which are also the focus of this proposal, are:
The policy of some hospitals in Taiwan that discourages the use of atypical antipsychotics for new onset schizophrenia directs the investigators to a study design looking at the associated diabetes of both types of antipsychotics. Such a design may provide some hints to the unresolved research issues mentioned above. Meanwhile, a broader defined term, X-syndrome, or metabolic syndrome, is being used to describe the diabetic condition associated with antipsychotics.
X-syndrome is a risky condition leading to cardiovascular diseases and diabetes, with insulin resistance as the major outcome, associated with two of the following conditions: truncal obesity (deposited in the thorax and abdomen, instead of the hips and thighs), high triglycerides, high low-density lipoprotein (LDL) cholesterol or hypertension. The proposed study will combine the phenotypes of diabetes and X-syndrome to explore the abnormal metabolism caused by antipsychotics, bridge important information gaps, and provide data contributing towards a better understanding of the risk and management of diabetes and X-syndrome associated with the use of antipsychotics. Three assessment tools, namely the Clinical Global Severity (Clinical Global Impressions - Severity) or the Positive and Negative Symptom Scale (PANNS), the Diabetes Risk Assessment (ADA) and the Life Style Survey, together with physical measurements, collect additional information for this study. Diabetes related biochemistry, including glucose, insulin, leptin, lipids and glycohemoglobin, will be measured to form a composite phenotype for further pharmacogenetic studies. Candidate genes involved in pancreatic beta cell insulin secretion will be examined in priority to see if they play a role in the development of the antipsychotics-induced diabetes.
Condition |
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Metabolic Syndrome Diabetes |
Study Type: | Observational |
Official Title: | Pharmacogenetic Profiling of Antipsychotics-Induced X-Syndrome and Diabetes (PAXD) |
Estimated Enrollment: | 1350 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | October 2008 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: El-Wui Loh, PhD | 886-2-26534401 ext 26715 | eloh@nhri.org.tw |
Taiwan | |
Song-de Branch, Taipei City Hospital | Not yet recruiting |
Taipei, Taiwan, 110 | |
Contact: Shih-Ku Lin, MD | |
Principal Investigator: Shih-Ku Lin, MD | |
Mackay Memorial Hospital | Not yet recruiting |
Taipei, Taiwan | |
Contact: Shen-Ing Liu, MD, PhD | |
Principal Investigator: Shen-Ing Liu, MD, PhD | |
Taiwan, Hu-lien County | |
Department of Health-Yuli Hospital | Recruiting |
Yuli, Hu-lien County, Taiwan, 981 | |
Contact: Tsuo Hung Lan, MD, PhD | |
Principal Investigator: Tsuo Hung Lan, MD, PhD |
Principal Investigator: | El-Wui Loh, PhD | Division of Mental Health and Drug Abuse Research, National Health Research Institutes |
Study ID Numbers: | EC0931203, MD-094-PP-04 |
Study First Received: | September 12, 2005 |
Last Updated: | November 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00201292 History of Changes |
Health Authority: | Taiwan: Department of Health |
Metabolic syndrome Diabetes Insulin resistance pharmacogenetics |
Tranquilizing Agents Metabolic Diseases Psychotropic Drugs Diabetes Mellitus Central Nervous System Depressants Endocrine System Diseases |
Endocrinopathy Insulin Resistance Antipsychotic Agents Glucose Metabolism Disorders Metabolic Disorder Insulin |
Metabolic Diseases Disease Tranquilizing Agents Physiological Effects of Drugs Psychotropic Drugs Diabetes Mellitus Endocrine System Diseases Central Nervous System Depressants |
Antipsychotic Agents Pharmacologic Actions Pathologic Processes Therapeutic Uses Syndrome Glucose Metabolism Disorders Central Nervous System Agents |