The Role of Apathy in Glycemic Control

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00844090
• Collaborator: (none)
• Enrollment: 106
• Location: 1
• Arms: 2
• Duration (Months): 39
• Patients Per Site Per Month: 2.7

Study Details

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	Phase
Apathy; Diabetes	Drug: methylphenidate or placebo	N/A

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
• 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: Jul 1, 2009
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Oct 1, 2012

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 [6 months from baseline]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 75 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	VA Medical Center, Omaha	Omaha	Nebraska	United States	68105-1873

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

• Principal Investigator: Cyrus DeSouza, MD, VA Medical Center, Omaha

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00844090
• Other Study ID Numbers: CLIN-011-08F
• First Posted: Feb 13, 2009
• Last Update Posted: Apr 21, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by US Department of Veterans Affairs: Apathy; Diabetes; Self-care behaviors
• Additional relevant MeSH terms: Methylphenidate

Study Results

Participant Flow

Recruitment Details	recruitment period Oct 2009- Jan 2012.Participants recruited from Omaha VA outpatient clinics
Pre-assignment Detail	All participants underwent a stress echo after consent. If stress echo was positive patient was not assigned to randomized arms

Arm/Group Title	Methylphenidate	Placebo
Arm/Group Description	methylphenidate methylphenidate 10mg twice daily P.O. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control	placebo placebo only to treat apathy to improve diabetes self care behaviors thereby improving glycemic control
Period Title: Overall Study
STARTED	52	54
COMPLETED	46	46
NOT COMPLETED	6	8

Baseline Characteristics

Arm/Group Title	Methylphenidate	Placebo	Total
Arm/Group Description	methylphenidate methylphenidate : treat apathy to improve diabetes self care behaviors thereby improving glycemic control	placebo methylphenidate : treat apathy to improve diabetes self care behaviors thereby improving glycemic control	Total of all reporting groups
Overall Participants	46	46	92
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	30 65.2%	29 63%	59 64.1%
>=65 years	16 34.8%	17 37%	33 35.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.7 (9.9)	56.0 (8.4)	55.3 (9.1)
Sex: Female, Male (Count of Participants)
Female	4 8.7%	3 6.5%	7 7.6%
Male	42 91.3%	43 93.5%	85 92.4%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

per protocol

Arm/Group Title	Methylphenidate	Placebo
Arm/Group Description	methylphenidate methylphenidate 10mg BID P.O. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control	placebo Placebo tabs BID P.O. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control
Measure Participants	46	46
Median (Standard Deviation) [percentage of HbA1c]	-1.0 (1.02)	-0.1 (1.04)

Adverse Events

Arm/Group Title	Methyphenidate		Placebo
Arm/Group Description	methylphenidate methylphenidate 10mg bid p.o.: treat apathy to improve diabetes self care behaviors thereby improving glycemic control		placebo Placebo bid p.o. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control
All Cause Mortality
	Methyphenidate		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Methyphenidate		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/46 (15.2%)		6/46 (13%)
Cardiac disorders
Blood Pressure and pulse	2/46 (4.3%)	3	2/46 (4.3%)	2
Gastrointestinal disorders
abdominal pain, nausea, loose stool	3/46 (6.5%)	3	2/46 (4.3%)	4
Infections and infestations
cellulitis	0/46 (0%)	0	1/46 (2.2%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer	1/46 (2.2%)	1	0/46 (0%)	0
Renal and urinary disorders
renal failure	1/46 (2.2%)	1	1/46 (2.2%)	1
Other (Not Including Serious) Adverse Events
	Methyphenidate		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	28/46 (60.9%)		25/46 (54.3%)
Gastrointestinal disorders
gastrointestinal	20/46 (43.5%)	32	17/46 (37%)	24
General disorders
fatigue	5/46 (10.9%)	5	7/46 (15.2%)	7
dizziness	3/46 (6.5%)	3	1/46 (2.2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.