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Completed

NCT Number: NCT00844090

The Role of Apathy in Glycemic Control

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.

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Key information

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Medical Center, Omaha

Omaha, Nebraska, 68105-1873, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methylphenidate or placebo

Drug

treat apathy to improve diabetes self care behaviors thereby improving glycemic control

Primary outcomes

  1. Change in HbA1c Over Baseline

    Time frame: 6 months from baseline

    measure of longer term glycemic control. A1c measured at baseline 6 weeks and 6 months

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Feb 13, 2009
Registry last updated
Apr 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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