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NCT02374996 · ClinicalTrials.gov registry record
Pharmacoepigenetics of Bipolar Disorder Treatment
A clinical trial, sponsored by Wayne State University.
- Completed
- Registry status
- 40
- Enrollment target
NCT02374996 is a clinical trial that has completed, run by Wayne State University. The registered enrollment target is 40 participants.
The verdict
NCT02374996 has completed, sponsored by Wayne State University.
- COMPLETED
- Registry status
- 40 participants
- Enrollment target
Study Summary
Insulin is a hormone produced by the body to regulate blood sugar. Insulin resistance is a state when the body is not using insulin correctly, and more insulin is needed to maintain normal blood sugar. Insulin resistance is common in bipolar patients and even more common in bipolar patients treated with antipsychotics. Insulin resistance from antipsychotics can lead to type 2 diabetes, metabolic syndrome and cardiovascular disease and is known to lead to worse psychiatric outcomes (less mood stability) and lower life expectancies in bipolar disorder. Abnormal regulation of the folate cycle is known to play a role in antipsychotic-induced insulin resistance and the main endpoint to the folate cycle is the production of methyl donors for DNA methylation. DNA methylation is critical as it regulates how genes are expressed. Thus, changes in DNA methylation may play a role in the disease process of antipsychotic-induced insulin resistance. The purpose of this study is to examine the differences in the DNA methylation of candidate tissues known to have a role in the development of insulin resistance. The three groups of bipolar patients to be studied are 1) antipsychotic treated patients with impaired glucose tolerance, 2) antipsychotic treated patients with normal glucose tolerance and 3) lithium treated patients with normal glucose tolerance. Group 1 will be compared to groups 2 and 3 in order to assess how DNA methylation in the skeletal muscle and fat tissue changes due to medication effects (group 2 vs. 3) and medication side effects (group 1 vs. 2). Secondary analyses include the analysis of how fats are processed in skeletal muscle and fat tissue in relation to antipsychotic-induced insulin resistance and the correlation of DNA methylation across different tissues. The investigators hypothesize that antipsychotic-induced insulin resistance is to due changes in the way DNA is expressed (through epigenetic changes) which causes further changes in the way fats are pro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2015-11 |
| Est. Completion | 2017-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02374996
The ClinicalTrials.gov registry entry for NCT02374996 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wayne State University, which has 163 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT02374996 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02374996 about?
NCT02374996 is a clinical study titled "Pharmacoepigenetics of Bipolar Disorder Treatment". Insulin is a hormone produced by the body to regulate blood sugar. Insulin resistance is a state when the body is not using insulin correctly, and more insulin is needed to maintain normal blood sugar. Insulin resistance is common in bipolar patients and even more common in bipolar patients treated ...
What is the current status of trial NCT02374996?
This trial is currently completed. The enrollment target is 40 participants. The study started on 2015-11. Estimated completion is 2017-09.
Who is sponsoring clinical trial NCT02374996?
This trial is sponsored by Wayne State University, which has 163 total clinical trials registered on ClinicalTrials.gov.
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