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NCT00756613 · ClinicalTrials.gov registry record
The VA Diabetes Trial Follow-up Study (VADT-FS)
A clinical trial, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- 1,044
- Enrollment target
NCT00756613: Completed study, sponsored by VA Office of Research and Development.
NCT00756613 is a clinical trial that has completed, run by VA Office of Research and Development. The registered enrollment target is 1,044 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00756613 has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- 1,044 participants
- Enrollment target
Study Summary
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. 1791 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 w
Primary Outcome
Major CV events (non-fatal MI resulting in hospitalization, non-fatal stroke, new Congestive Heart Failure (CHF), amputation for ischemic diabetic gangrene, or CV-related death).
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,044 participants |
| Start Date | 2008-02-01 |
| Est. Completion | 2017-12-31 |
What the finished NCT00756613 record still lists
NCT00756613 is an observational study that tracks outcomes without assigning an intervention. Its 1,044 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT00756613 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00756613 about?
NCT00756613 is a clinical study titled "The VA Diabetes Trial Follow-up Study (VADT-FS)". 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 ar...
What is the current status of trial NCT00756613?
This trial is currently completed. The enrollment target is 1,044 participants. The study started on 2008-02-01. Estimated completion is 2017-12-31.
Who is sponsoring clinical trial NCT00756613?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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