N/A
N=106
The Role of Apathy in Glycemic Control
Apathy · Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00844090 ↗Enrolled (actual)
106
Serious AEs
14.1%
Results posted
Apr 2014
Primary outcome: Primary: Change in HbA1c Over Baseline — -1.0; -0.1 percentage of HbA1c
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- methylphenidate or placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c Over Baseline |
-1.0; -0.1 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT00844090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.