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The Role of Apathy in Glycemic Control

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ClinicalTrials.gov Identifier: NCT00844090
Recruitment Status : Completed
First Posted : February 13, 2009
Results First Posted : April 21, 2014
Last Update Posted : April 21, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Apathy Diabetes Drug: methylphenidate or placebo

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Apathy in Glycemic Control
Study Start Date : July 2009
Primary Completion Date : August 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Arm 1
placebo tablets
Drug: methylphenidate or placebo
treat apathy to improve diabetes self care behaviors thereby improving glycemic control
Experimental: Arm 2
methylphenidate tablets
Drug: methylphenidate or placebo
treat apathy to improve diabetes self care behaviors thereby improving glycemic control

Outcome Measures

Primary Outcome Measures :
  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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00844090

United States, Nebraska
VA Medical Center, Omaha
Omaha, Nebraska, United States, 68105-1873
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Cyrus DeSouza, MD VA Medical Center, Omaha
More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00844090     History of Changes
Other Study ID Numbers: CLIN-011-08F
First Posted: February 13, 2009    Key Record Dates
Results First Posted: April 21, 2014
Last Update Posted: April 21, 2014
Last Verified: March 2014

Keywords provided by VA Office of Research and Development:
Self-care behaviors

Additional relevant MeSH terms:
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents