Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed study, sponsored by Wayne State University.
NCT02374996 is a clinical trial that has completed, run by Wayne State University. The registered enrollment target is 40 participants. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The prevalence of DNA methylation of cytosine-phosphate-guanosine (CpG) Island 81 of the Fatty Acyl Coenzyme A Reductase gene will be compared amongst the groups. The is reported as % methylation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2015-11 |
| Est. Completion | 2017-09 |
What the finished NCT02374996 record still lists
NCT02374996 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02374996 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01306019 · 40 participants · Phase 1
Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)
- NCT01608152 · 40 participants
Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors
- NCT01668082 · 40 participants · NA
An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection
- NCT02015013 · 40 participants · Phase 2
Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia