The Role of Apathy in Glycemic Control

Diabetes Clinical Trial

Official title:

The Role of Apathy in Glycemic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00844090
• Other study ID #: CLIN-011-08F
• Status: Completed
• Phase: N/A
• First received: February 12, 2009
• Last updated: March 18, 2014
• Start date: July 2009
• Est. completion date: October 2012

Study information

• Verified date: March 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: October 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apathy
• Diabetes

Intervention

Drug:
• methylphenidate or placebo
treat apathy to improve diabetes self care behaviors thereby improving glycemic control

Locations

Country	Name	City	State
United States	VA Medical Center, Omaha	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c Over Baseline	measure of longer term glycemic control. A1c measured at baseline 6 weeks and 6 months	6 months from baseline	No