Myelin, Glia and Depression in Type 2 Diabetes
2 other identifiers
observational
400
1 country
1
Brief Summary
The purpose of the study is to examine the relationship between brain structure and depression in adults aged 30 or older with Diabetes. This relationship is determined using magnetic resonance imaging technology (MRI), a scanner with a magnet that is used to create images of the brain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 19, 2009
CompletedFirst Submitted
Initial submission to the registry
March 30, 2011
CompletedFirst Posted
Study publicly available on registry
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedMay 20, 2025
May 1, 2025
5 years
March 30, 2011
May 14, 2025
Conditions
Keywords
Study Arms (4)
Depressed
Patients with Major Depressive Disorder
Diabetic
Patients with Type 2 Diabetes
Diabetic/Depressed
Patients with both diabetes and major depressive disorder
Healthy Controls
Eligibility Criteria
Patients of all subject types will be recruited through the general medical, psychiatric, and endocrinology clinics associated with the UIC Medical Center. Patients will be first cleared for participation in the study by their primary physicians. The patient and family will be approached by the PI or another investigator who will explain the research and its goals. We also plan to recruit subjects through flyers and advertisements.
You may qualify if:
- Age: 30 to 80 years old
- Diagnosis of type 2 diabetes
- Diagnosis of major depressive disorder using standard diagnostic and statistical manual (DSM) criteria
- Score of 15 or greater on the 17-item Hamilton Depression rating scale
- Mini Mental Status Exam score of 24 or greater
- No evidence of clinical dementia or any other clinical brain disorder
- Free of psychotropic/psychoactive medications for at least 2 weeks
- First episode of depression diagnosed either after or around the time type 2 diabetes was diagnosed since we are interested in the relationship between the cerebrovascular effect of diabetes and the pathophysiology of major depression
You may not qualify if:
- Presence of dementia or any other clinical brain disorder (Parkinson's, Alzheimer's)
- Mini Mental Status Exam score of less than 24
- Unstable medical illness (grade 4 on the Cumulative Illness Rating Scale)
- Presence of any metallic implant that would preclude an MRI scan (pacemaker, etc.)
- Concurrent Axis 1 disorder (schizophrenia, bipolar)
- Use of atypical neuroleptics for the current episode and/or strong clinical suspicion that the diabetes is secondary to the use of atypical neuroleptics;
- Recurrent major depression, operationally defined as two or more, well-characterized episodes of depression, prior to the onset/diagnosis of diabetes
- Seizure disorder
- Stroke/Transient Ischemic Attack
- Central nervous system disorder (multiple sclerosis)
- Trauma to head/Loss of Consciousness
- Claustrophobia
- Eating disorder (anorexia, bulimia)
- Weight of over 350 pounds
- Learning disorder (dyslexia, ADHD)
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois
Chicago, Illinois, 60612, United States
Related Publications (4)
Ajilore O, Narr K, Rosenthal J, Pham D, Hamilton L, Watari K, Elderkin-Thompson V, Darwin C, Toga A, Kumar A. Regional cortical gray matter thickness differences associated with type 2 diabetes and major depression. Psychiatry Res. 2010 Nov 30;184(2):63-70. doi: 10.1016/j.pscychresns.2010.07.003. Epub 2010 Sep 15.
PMID: 20832254RESULTNguyen TT, Wong TY, Islam FM, Hubbard L, Ajilore O, Haroon E, Darwin C, Esser B, Kumar A. Evidence of early retinal microvascular changes in patients with type 2 diabetes and depression. Psychosom Med. 2010 Jul;72(6):535-8. doi: 10.1097/PSY.0b013e3181da90f4. Epub 2010 Apr 5.
PMID: 20368470RESULTKumar A, Gupta R, Thomas A, Ajilore O, Hellemann G. Focal subcortical biophysical abnormalities in patients diagnosed with type 2 diabetes and depression. Arch Gen Psychiatry. 2009 Mar;66(3):324-30. doi: 10.1001/archgenpsychiatry.2008.548.
PMID: 19255382RESULTWatari K, Elderkin-Thompson V, Ajilore O, Haroon E, Darwin C, Pham D, Kumar A. Neuroanatomical correlates of executive functioning in depressed adults with type 2 diabetes. J Clin Exp Neuropsychol. 2008 May;30(4):389-97. doi: 10.1080/13803390701440486.
PMID: 18938677RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anand Kumar, MD
University of Illinois at Chicago
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2011
First Posted
April 1, 2011
Study Start
October 19, 2009
Primary Completion
October 7, 2014
Study Completion
November 1, 2014
Last Updated
May 20, 2025
Record last verified: 2025-05