The Role of Apathy in Glycemic Control

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00844090
First received: February 12, 2009
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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 Intervention
Apathy
Diabetes
Drug: methylphenidate or placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Apathy in Glycemic Control

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change in HbA1c Over Baseline [ Time Frame: 6 months from baseline ] [ Designated as safety issue: No ]
    measure of longer term glycemic control. A1c measured at baseline 6 weeks and 6 months


Enrollment: 106
Study Start Date: July 2009
Study Completion Date: October 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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<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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844090

Locations
United States, Nebraska
VA Medical Center, Omaha
Omaha, Nebraska, United States, 68105-1873
Sponsors and Collaborators
Investigators
Principal Investigator: Cyrus DeSouza, MD VA Medical Center, Omaha
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00844090     History of Changes
Other Study ID Numbers: CLIN-011-08F
Study First Received: February 12, 2009
Results First Received: December 2, 2013
Last Updated: March 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Apathy
Diabetes
Self-care behaviors

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014