ApathyNCT00844090
The Role of Apathy in Glycemic Control
A study of Apathy and Diabetes, run by US Department of Veterans Affairs at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Oct 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, Omaha
Omaha, Nebraska, 68105-1873
About this study
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.
- Being tested
- methylphenidate or placebo
- Keywords
- Apathy, Diabetes, Self-care behaviors
- Medical subject headings
- Lethargy, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylphenidate or placeboDrug
treat apathy to improve diabetes self care behaviors thereby improving glycemic control
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Placebo comparator | placebo tablets Receives: Drug: methylphenidate or placebo |
| Arm 2 | Experimental | methylphenidate tablets Receives: Drug: methylphenidate or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c Over Baseline
measure of longer term glycemic control. A1c measured at baseline 6 weeks and 6 months
Measured: 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ApathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Cyrus DeSouza, MD, Principal investigator, VA Medical Center, Omaha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844090
- Sponsor's protocol ID
- CLIN-011-08F
- Status last verified
- Mar 2014
- First submitted
- 12 Feb 2009
- Last updated
- 21 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Apathy in Glycemic Control
- ClinicalTrials.gov ID
- NCT00844090
- Acronym / sponsor ID
- CLIN-011-08F
- Keywords
- Apathy, Diabetes, Self-care behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jul 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 13 Feb 2009 (estimated)
- Results
- Posted 21 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Placebo comparator | Drug: methylphenidate or placeboplacebo tablets |
| Arm 2 | Experimental | Drug: methylphenidate or placebomethylphenidate tablets |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylphenidate or placebotreat apathy to improve diabetes self care behaviors thereby improving glycemic control | Drug | Arm 1, Arm 2 |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cyrus DeSouza, MD principal investigator
VA Medical Center, Omaha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Apathy and Diabetes, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c Over Baseline (time frame: 6 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.