Status:
COMPLETED
The Role of Apathy in Glycemic Control
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Apathy
Diabetes
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
In spite of several new medications and insulins for the control of blood sugars in patients with diabetes, a large number of patients do not have good control. This likely due to inability to carry o...
Detailed Description
The incidence of diabetes in the US is at epidemic proportions. A large number of diabetes patients in the VA system have uncontrolled diabetes with high HbA1c. The inability to carry out important se...
Eligibility Criteria
Inclusion
- Poor glycemic control HbA1c\>8
- Presence of apathy, a score of \>30 on AES
- Subjects should be on stable dose of metformin, thiozolidinediones, and sulfonylureas, statins and ACE inhibitors for at least two months
- Subjects should have a negative cardiac stress test within the previous year
Exclusion
- Presence of major depressive disorder, psychosis, suicidal ideations, and history of stimulant dependence as evaluated by MINI.
- Patient currently being treated or a history hypersensitivity to methylphenidate
- Hypertension with BP\>140/90
- History of renal disease with GFR\<60
- History of hepatic failure with AST/ALT \> three times the normal range
- History of seizure disorder, or Tourette's syndrome or presence of motor tics
- Patients with glaucoma
- Patients being treated with monoamine oxidase inhibitors (MAOIs) or Clonidine
- Patients with active cancer.
- Patients with acute illness needing hospitalization
- Patients with cardiovascular events such as myocardial infarction, stroke, amputation, unstable angina within the last six months.
- HbA1c\> 12
- Planned elective surgery in next 6 months
- Pregnancy
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00844090
Start Date
July 1 2009
End Date
October 1 2012
Last Update
April 21 2014
Active Locations (1)
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1
VA Medical Center, Omaha
Omaha, Nebraska, United States, 68105-1873