The Role of Apathy in Glycemic Control

Not Applicable

Completed

• Conditions: Apathy; Diabetes
• Interventions: Drug: methylphenidate or placebo

• Registration Number: NCT00844090
• Lead Sponsor: US Department of Veterans Affairs

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.

Study Timeline

• Study First Submitted: 2009-02-12
• Study First Submitted QC: 2009-02-12
• Study First Posted: 2009-02-13
• Study Start: 2009-07
• Primary Completion: 2012-08
• Study Completion: 2012-10
• Results First Submitted: 2013-12-02
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-18
• Last Update Submitted: 2014-03-18
• Results First Posted: 2014-04-21
• Last Update Posted: 2014-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	methylphenidate or placebo	placebo tablets
Arm 2	methylphenidate or placebo	methylphenidate tablets

Primary Outcome Measures

Name	Time	Method
Change in HbA1c Over Baseline	6 months from baseline	measure of longer term glycemic control. A1c measured at baseline 6 weeks and 6 months

Trial Locations

Locations (1)

VA Medical Center, Omaha; 🇺🇸 Omaha, Nebraska, United States