The Role of Apathy in Glycemic Control
Completed · Not applicable · Has a placebo group
Conditions studied: Apathy, Diabetes
In brief
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 out regular activities and self-care behaviors such as taking meds regularly, keeping a good diet, exercise etc. This inability to carry out self care lifestyle changes may be due to a condition called apathy. Apathy is a lack of motivation and persistence. In this study we will attempt to treat apathy with a medication called methylphenidate for 6 months and see if blood sugar/diabetes control improves.
Key facts
- Study ID
- NCT00844090
- Run by
- US Department of Veterans Affairs
- People needed
- 106
- Starts
- 2009-07-01
- Expected to finish
- 2012-10-01
- Last updated by the study team
- 2014-04-21
Who can join
Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- VA Medical Center, Omaha — Omaha, Nebraska, United States
Full record on ClinicalTrials.gov
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