The VA Diabetes Trial Follow-up Study (VADT-FS)
| Status: | Completed |
|---|---|
| Conditions: | Endocrine, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 10/5/2017 |
| Start Date: | February 1, 2008 |
| End Date: | May 1, 2017 |
CSP #465FS - VA Diabetes Trial Long Term Follow-up Study
CSP #465, "Glycemic Control and Complications in Diabetes Mellitus Type 2," was a randomized
unblinded clinical trial comparing tight glycemic control to standard glycemic control. Tight
glycemic control consisted of giving patients appropriate diabetic medications to lower the
patient's HbA1c to around 7%, whereas standard control attempted to lower the patient's HbA1c
to between 8% and 9%. The study was conducted at 20 VA medical centers. One thousand seven
hundred and ninety two patients were randomized over the 2 year accrual period and then
followed for an additional 5 years. Follow-up averaged between 5 and 7 years depending upon
when the patient was enrolled in the study. Patients were seen on average every three months
in the VA Outpatient Clinics. High blood pressure and elevated cholesterol were aggressively
treated in patients in both treatment arms. Education regarding diet, exercise, smoking
cessation and management of very high and very low glucose was also provided. Data were
collected throughout the study on the patients' physical status, adverse and serious adverse
events, concomitant medications, and study end points including mortality, heart attack,
stroke and surgery to fix the arteries in the heart, legs or neck. The study consisted of
broad use of all anti-diabetic treatments commercially available between 2000 and 2008
including oral medications and insulin. Study required medications and all study clinic
visits were provided free of the usual VA co-pay. Active clinical follow-up of the sample
ended on May 31, 2008. With the end of the clinical trial the patients were transitioned back
to usual patient care services, treatment regimens were adjusted where appropriate and future
treatment will be dictated by the patient's health and his/her health care provider.
It is important to clarify that with the completion of the active clinical trial and
transitioning of patients to this observational trial, all responsibility for the care,
treatment and oversight of the study patients will become the responsibility of the patients'
Primary Care Physician. The Long Term Follow-up will not collect adverse or serious adverse
events, or actively treat or have any "hands-on" care responsibility for the study
participants.
The proposed Long Term Follow-up Study will consist of centralized computer database searches
and annual survey questionnaires related to quality of life and self-reported events
pertinent to the CSP #465 study.
unblinded clinical trial comparing tight glycemic control to standard glycemic control. Tight
glycemic control consisted of giving patients appropriate diabetic medications to lower the
patient's HbA1c to around 7%, whereas standard control attempted to lower the patient's HbA1c
to between 8% and 9%. The study was conducted at 20 VA medical centers. One thousand seven
hundred and ninety two patients were randomized over the 2 year accrual period and then
followed for an additional 5 years. Follow-up averaged between 5 and 7 years depending upon
when the patient was enrolled in the study. Patients were seen on average every three months
in the VA Outpatient Clinics. High blood pressure and elevated cholesterol were aggressively
treated in patients in both treatment arms. Education regarding diet, exercise, smoking
cessation and management of very high and very low glucose was also provided. Data were
collected throughout the study on the patients' physical status, adverse and serious adverse
events, concomitant medications, and study end points including mortality, heart attack,
stroke and surgery to fix the arteries in the heart, legs or neck. The study consisted of
broad use of all anti-diabetic treatments commercially available between 2000 and 2008
including oral medications and insulin. Study required medications and all study clinic
visits were provided free of the usual VA co-pay. Active clinical follow-up of the sample
ended on May 31, 2008. With the end of the clinical trial the patients were transitioned back
to usual patient care services, treatment regimens were adjusted where appropriate and future
treatment will be dictated by the patient's health and his/her health care provider.
It is important to clarify that with the completion of the active clinical trial and
transitioning of patients to this observational trial, all responsibility for the care,
treatment and oversight of the study patients will become the responsibility of the patients'
Primary Care Physician. The Long Term Follow-up will not collect adverse or serious adverse
events, or actively treat or have any "hands-on" care responsibility for the study
participants.
The proposed Long Term Follow-up Study will consist of centralized computer database searches
and annual survey questionnaires related to quality of life and self-reported events
pertinent to the CSP #465 study.
Diabetes mellitus is a major health problem in the U.S., especially in the VA population. The
majority of diabetics are Type 2, and they are at risk for microvascular (e.g. eye, kidney)
and macrovascular (e.g.
cardiovascular) complications. It is probable that many of the macrovascular and
microvascular complications potentially prevented by the 5-7 years of good Glycemic control
achieved in the VADT (median follow-up 6.25 years) will occur years after completion of the
VADT experimental protocol. This follow-up study will provide the opportunity to see if this
holds true up to 9 years following the end of 465.
The results will help the VA in evaluating most appropriate treatments and costs of such
treatment.
This is a longitudinal observational follow-up study of CSP #465, "Glycemic Control and
Complications in Diabetes Mellitus Type 2",the VA Diabetes Trial (VADT). The objectives are:
1) to determine the long term effects of intensive glycemic control in type 2 diabetes on
major cardiovascular complications (primary outcome), and 2) to determine the long term
effects of intensive glycemic control in type 2 diabetes on four secondary outcomes: a)
cardiovascular mortality, b) major microvascular complications, c) health-related quality of
life, and d) total mortality. All patients active at the end of VADT will be approached for
participation in VADT-FS. The only exclusion reason will be failure to receive consent for
participation. Consented VADT-FS patients will be followed until the end of the study unless
they withdraw their consent. Patients will be sent a short, standardized self-administered
survey annually. Information collected will include: 1) self-reported health status; 2)
occurrence of study endpoints; and 3) VA or non-VA outpatient visits, hospitalizations and
procedures. A variety of data sources will be searched to verify endpoints. These sources
include: 1) VA and non-VA medical records; 2) data from the Centers for Medicare and Medicaid
Services (CMS); and 3) VA and US death records. Patients who do not respond to 3 mailed
surveys will be contacted by phone.
If still unsuccessful, their designated surrogate will be contacted. Certain endpoints will
be adjudicated by the same committee that was utilized by VADT. Endpoints that will be
adjudicated will include: 1) cause of death; 2) reason for amputation; and 3) cardiac-related
non-VA hospitalizations. Endpoints of interest in this study include: 1) mortality; 2) acute
myocardial infarction requiring hospitalization; 3) stroke; 4) new onset congestive heart
failure; 5) coronary revascularization; 6) amputation; 7) peripheral revascularization; 8)
renal insufficiency; 9) severe visual impairment; and 10) self-reported health status
(diabetes-related quality of life).
majority of diabetics are Type 2, and they are at risk for microvascular (e.g. eye, kidney)
and macrovascular (e.g.
cardiovascular) complications. It is probable that many of the macrovascular and
microvascular complications potentially prevented by the 5-7 years of good Glycemic control
achieved in the VADT (median follow-up 6.25 years) will occur years after completion of the
VADT experimental protocol. This follow-up study will provide the opportunity to see if this
holds true up to 9 years following the end of 465.
The results will help the VA in evaluating most appropriate treatments and costs of such
treatment.
This is a longitudinal observational follow-up study of CSP #465, "Glycemic Control and
Complications in Diabetes Mellitus Type 2",the VA Diabetes Trial (VADT). The objectives are:
1) to determine the long term effects of intensive glycemic control in type 2 diabetes on
major cardiovascular complications (primary outcome), and 2) to determine the long term
effects of intensive glycemic control in type 2 diabetes on four secondary outcomes: a)
cardiovascular mortality, b) major microvascular complications, c) health-related quality of
life, and d) total mortality. All patients active at the end of VADT will be approached for
participation in VADT-FS. The only exclusion reason will be failure to receive consent for
participation. Consented VADT-FS patients will be followed until the end of the study unless
they withdraw their consent. Patients will be sent a short, standardized self-administered
survey annually. Information collected will include: 1) self-reported health status; 2)
occurrence of study endpoints; and 3) VA or non-VA outpatient visits, hospitalizations and
procedures. A variety of data sources will be searched to verify endpoints. These sources
include: 1) VA and non-VA medical records; 2) data from the Centers for Medicare and Medicaid
Services (CMS); and 3) VA and US death records. Patients who do not respond to 3 mailed
surveys will be contacted by phone.
If still unsuccessful, their designated surrogate will be contacted. Certain endpoints will
be adjudicated by the same committee that was utilized by VADT. Endpoints that will be
adjudicated will include: 1) cause of death; 2) reason for amputation; and 3) cardiac-related
non-VA hospitalizations. Endpoints of interest in this study include: 1) mortality; 2) acute
myocardial infarction requiring hospitalization; 3) stroke; 4) new onset congestive heart
failure; 5) coronary revascularization; 6) amputation; 7) peripheral revascularization; 8)
renal insufficiency; 9) severe visual impairment; and 10) self-reported health status
(diabetes-related quality of life).
Inclusion Criteria:
- All patients active at the end of VADT will be approached for participation.
Exclusion Criteria:
- The only exclusion criterion will be failure to achieve consent for continued
participation.
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2
sites
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