The Role of Apathy in Glycemic Control

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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