Apathy, Diabetes
Conditions
Keywords
Apathy, Diabetes, Self-care behaviors
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.
Interventions
DRUGmethylphenidate or placebo
treat apathy to improve diabetes self care behaviors thereby improving glycemic control
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c Over Baseline | 6 months from baseline | measure of longer term glycemic control. A1c measured at baseline 6 weeks and 6 months |
Countries
United States
Participant flow
Recruitment details
recruitment period Oct 2009- Jan 2012.Participants recruited from Omaha VA outpatient clinics
Pre-assignment details
All participants underwent a stress echo after consent. If stress echo was positive patient was not assigned to randomized arms
Participants by arm
| Arm | Count |
|---|---|
| Methylphenidate methylphenidate
methylphenidate : treat apathy to improve diabetes self care behaviors thereby improving glycemic control | 46 |
| Placebo placebo
methylphenidate : treat apathy to improve diabetes self care behaviors thereby improving glycemic control | 46 |
| Total | 92 |
Baseline characteristics
| Characteristic | Total | Methylphenidate | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 33 Participants | 16 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 59 Participants | 30 Participants | 29 Participants |
| Age, Continuous | 55.3 years STANDARD_DEVIATION 9.1 | 54.7 years STANDARD_DEVIATION 9.9 | 56.0 years STANDARD_DEVIATION 8.4 |
| Sex: Female, Male Female | 7 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Male | 85 Participants | 42 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 28 / 46 | 25 / 46 |
| serious Total, serious adverse events | 7 / 46 | 6 / 46 |
Outcome results
Primary
Change in HbA1c Over Baseline
measure of longer term glycemic control. A1c measured at baseline 6 weeks and 6 months
Time frame: 6 months from baseline
Population: per protocol
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Methylphenidate | Change in HbA1c Over Baseline | -1.0 percentage of HbA1c | Standard Deviation 1.02 |
| Placebo | Change in HbA1c Over Baseline | -0.1 percentage of HbA1c | Standard Deviation 1.04 |