Hemoglobin A1c and Immediate Postsurgical Complications Diabetes Type 2 (HbA1c)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Hemoglobin A1c and Immediate Postsurgical Complications Diabetes Type 2 (HbA1c)|
- Compare incidence of immediate post surgery complications in diabetic patients with HbA1c > 7 and patients with HbA1c ≤ 7 [ Time Frame: 30 days postsurgery ] [ Designated as safety issue: No ]Incidence of death, infections, cardiovascular o brainvascular disease
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
HbA1c > 7
Diabetic patients with HbA1c > 7
HbA1c ≤ 7
Diabetic patients with HbA1c ≤ 7
The diabetes is a highly prevalent disease in patients who undergo an evaluation previous to a surgery. The most efficient glucose control, in patients with diabetes type II, reduces the risk of microvascular complications. Diabectic patients who underwent scheduled cardivacular or noncardiovascular surgeries show an increase rate of immediate and long-term complications. The most frequent complications are infections, cardiovascular events and death.
Intensive insulinisation during cardiovascular surgery reduces the risk of a new coronary event in the immediate post surgery. No studies have been found that show the evaluation of Hemoglobin A1c values before the surgery and the immediate post surgery complications.
A poor glycemic control has been associated to a large number of chronic complications like diabetic neuropathy, nephropathy, retinopathy and infection disease. The Hemoglobin A1c is used like a marker of the glycemic control in the last 120 days and has a correlation with the no enzyme glicosilation. This marker could have a relation with the complication after the programmed surgery.
This study will evaluate the incidence of complications in the immediate post operatory in patients with diabetes type II in relation to the hemoglobin A1c before the surgery. If the hemoglobin A1c has a correlation with the incidence of cardiovascular complications, this could mark a change in the therapeutic measures prior the programmed surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403961
|Contact: Javier Giunta, MD||+541149590200 ext firstname.lastname@example.org|
|Hospital Italiano de Buenos Aires||Recruiting|
|Buenos Aires, Argentina, C1181ACH|
|Contact: Javier Giunta, MD 541149590200 ext 4419 email@example.com|
|Principal Investigator: Diego Giunta, MD|
|Principal Investigator:||Diego Giunta, MD||AIMI. HIBA.|
|Study Director:||Javier GIunta, MD||HIBA|
|Study Chair:||Carlos Bonofiglio, MD||HIBA|
|Study Chair:||Leon Litwak, MD||HIBA|