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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Placebo Comparator | placebo tablets |
|
| Arm 2 | Experimental | methylphenidate tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylphenidate or placebo | Drug | treat apathy to improve diabetes self care behaviors thereby improving glycemic control |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c Over Baseline | measure of longer term glycemic control. A1c measured at baseline 6 weeks and 6 months | 6 months from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cyrus DeSouza, MD | VA Medical Center, Omaha | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Omaha | Omaha | Nebraska | 68105-1873 | United States |
All participants underwent a stress echo after consent. If stress echo was positive patient was not assigned to randomized arms
recruitment period Oct 2009- Jan 2012.Participants recruited from Omaha VA outpatient clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Methylphenidate | methylphenidate methylphenidate 10mg twice daily P.O. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control |
| FG001 | Placebo | placebo placebo only to treat apathy to improve diabetes self care behaviors thereby improving glycemic control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The number of participants for analysis was 92 in total since only 92 participants completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Methylphenidate | methylphenidate methylphenidate : treat apathy to improve diabetes self care behaviors thereby improving glycemic control |
| BG001 | Placebo | placebo methylphenidate : treat apathy to improve diabetes self care behaviors thereby improving glycemic control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in HbA1c Over Baseline | measure of longer term glycemic control. A1c measured at baseline 6 weeks and 6 months | per protocol | Posted | Median | Standard Deviation | percentage of HbA1c | 6 months from baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Methyphenidate | methylphenidate methylphenidate 10mg bid p.o.: treat apathy to improve diabetes self care behaviors thereby improving glycemic control |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood Pressure and pulse | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gastrointestinal | Gastrointestinal disorders | Systematic Assessment | nausea , bloating collected as GI organ system. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cyrus Desouza MD | Omaha VA Medical Center | 402-995-5506 | cyrus.desouza@va.gov |
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| ID | Term |
|---|---|
| D053609 | Lethargy |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 7 |
| 46 |
| 28 |
| 46 |
| EG001 | Placebo | placebo Placebo bid p.o. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control | 6 | 46 | 25 | 46 |
| abdominal pain, nausea, loose stool | Gastrointestinal disorders | Systematic Assessment | adverse events only collected by organ system. |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| renal failure | Renal and urinary disorders | Systematic Assessment |
|
| cellulitis | Infections and infestations | Non-systematic Assessment | hospitalization for cellulitis |
|
|
| fatigue | General disorders | Non-systematic Assessment |
|
| dizziness | General disorders | Non-systematic Assessment | mild self limited |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |