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The VA Diabetes Trial Follow-up Study (VADT-FS)
trial in Diabetes in 1,044 participants. Completed in 31 December 2017.
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,044 |
| Start date | 1 February 2008 |
| Primary completion | 31 December 2015 |
| Estimated completion | 31 December 2017 |
| Sites | 2 locations across United States |
VA Office of Research and Development — full company profile →
40 and older, any sex, with Diabetes or Glycemic Control. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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).
| Group | Value | 95% CI |
|---|---|---|
| 465 VADT Participants - Standard | 336 | |
| 465 VADT Participants -Intensive | 325 |
The major secondary end-point of cardiovascular (CV) mortality will measure the cause of death (end-stage renal disease, amputation for either ischemic or non-ischemic gangrene, CV-related death, or nonfatal myocardial infarction (MI), stroke, or new congestive heart failure (CHF)) retrieved by the National Death Index (NDI). Survival analysis will analyzed by time of event to death.
| Group | Value | 95% CI |
|---|---|---|
| 465 VADT Participants - Standard | 366 | |
| 465 VADT Participants -Intensive | 376 |
The major secondary end-point of total mortality will measure all deaths with data retrieved from VA Information Resource Center (VIREC) Cooperate Data Warehouse (CDW) . Survival analysis will analyzed by time to death.
| Group | Value | 95% CI |
|---|---|---|
| 465 VADT Participants - Standard | 125 | |
| 465 VADT Participants -Intensive | 118 |
End-stage renal disease, amputation for either ischemic or non-ischemic gangrene, CV-related death, or nonfatal MI, stroke, or new CHF.
| Group | Value | 95% CI |
|---|---|---|
| 465 VADT Participants - Standard | 355 | |
| 465 VADT Participants -Intensive | 342 |
Self-reported health status using an instrument adapted for type 2 diabetes mellitus patients from the Diabetes Control and Complications Trial (DCCT) (Duckworth, 1998; Saudek 1996). This survey tool has been used since the inception of the VADT and will be continued in the annual survey. The minimum value is 0 and the maximum value is 100. The higher score is a better outcome.
| Group | Value | 95% CI |
|---|---|---|
| 465 VADT Participants - Standard | 62.2 | ± 17.6 |
| 465 VADT Participants -Intensive | 63.8 | ± 17.2 |
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 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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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