The Role of Apathy in Glycemic Control

Study Overview
=================
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 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.

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 self-care behaviors such as measuring blood sugars regularly, following diet, exercise and medication programs may be due to apathy. Apathy is the lack of motivation, persistence and novelty. We have found this to be very prevalent in the VA diabetes population. We now do a randomized placebo controlled trial to see if treatment of apathy with methylphenidate will improve glycemic control in patients with A1c >8. Treatment will be for 6 months. The primary end point is HbA1c.

Official Title
-----------------
The Role of Apathy in Glycemic Control

Conditions
-----------------
Apathy, Diabetes

Intervention / Treatment
-----------------
* Drug: methylphenidate or placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm 1<br>placebo tablets | Drug: methylphenidate or placebo<br>* treat apathy to improve diabetes self care behaviors thereby improving glycemic control<br>|
| Experimental: Arm 2<br>methylphenidate tablets | Drug: methylphenidate or placebo<br>* treat apathy to improve diabetes self care behaviors thereby improving glycemic control<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c Over Baseline | measure of longer term glycemic control. A1c measured at baseline 6 weeks and 6 months | 6 months from baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Apathy, Diabetes, Self-care behaviors