CompletedNCT00844090Updated Apr 21, 2014Results posted

The Role of Apathy in Glycemic Control

An interventional study of methylphenidate or placebo in Apathy and Diabetes, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-04-21.

Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 106
Allocation: Randomized
Ages: 21 Years to 75 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Apathy
Diabetes

Keywords

Apathy
Diabetes
Self-care behaviors

In context

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 75 Years
Sexes eligible: 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

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 106 participants (actual)

Study arms

Placebo comparator
Arm 1
placebo tablets
Drug: methylphenidate or placebo
Experimental
Arm 2
methylphenidate tablets
Drug: methylphenidate or placebo

Interventions

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

What researchers measure

Primary outcomes

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

Results

Posted Apr 21, 2014

Participant flow

recruitment period Oct 2009- Jan 2012.Participants recruited from Omaha VA outpatient clinics

Participant flow — Overall Study
Milestone	Methylphenidate	Placebo
Started	52	54
Completed	46	46
Not completed	6	8

Outcome measures

PrimaryChange in HbA1c Over Baseline

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

Time frame:: 6 months from baseline
Reported as:: Median · percentage of HbA1c

Change in HbA1c Over Baseline
percentage of HbA1c	Methylphenidate	Placebo
Change in HbA1c Over Baseline	-1.0 ± 1.02	-0.1 ± 1.04

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Methyphenidate	—	7/46 (15.2%)	28/46 (60.9%)
Placebo	—	6/46 (13%)	25/46 (54.3%)

Most frequent serious events

Most frequent serious events
Event	Methyphenidate	Placebo
abdominal pain, nausea, loose stoolGastrointestinal disorders	3/46	2/46
Blood Pressure and pulseCardiac disorders	2/46	2/46
Prostate CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/46	0/46
renal failureRenal and urinary disorders	1/46	1/46
cellulitisInfections and infestations	0/46	1/46

Most frequent other events

Most frequent other events
Event	Methyphenidate	Placebo
gastrointestinalGastrointestinal disorders	20/46	17/46
fatigueGeneral disorders	5/46	7/46
dizzinessGeneral disorders	3/46	1/46

Baseline characteristics

The number of participants for analysis was 92 in total since only 92 participants completed the study.

Age, Categorical
Age, Categorical(Participants)	Methylphenidate	Placebo	Total
<=18 years	0	0	0
Between 18 and 65 years	30	29	59
>=65 years	16	17	33

Age, Continuous
Age, Continuous(years)	Methylphenidate	Placebo	Total
Mean	54.7 ± 9.9	56.0 ± 8.4	55.3 ± 9.1

Sex: Female, Male
Sex: Female, Male(Participants)	Methylphenidate	Placebo	Total
Female	4	3	7
Male	42	43	85

Study locations

1 site

VA Medical Center, Omaha
Omaha, Nebraska 68105-1873, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00844090
Lead sponsor: US Department of Veterans Affairs
Responsible party: Sponsor
First posted: Feb 13, 2009
Start date: Jul 2009
Primary completion: Aug 2012
Completion: Oct 2012
Results posted: Apr 21, 2014
Last update: Apr 21, 2014

Study contacts

Cyrus DeSouza, MD

principal investigator · VA Medical Center, Omaha

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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