Viewing Study NCT01403961


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Study NCT ID: NCT01403961
Status: COMPLETED
Last Update Posted: 2019-08-13
First Post: 2011-07-26
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Hemoglobin A1c and Immediate Postsurgical Complications Diabetes Type 2
Sponsor: Hospital Italiano de Buenos Aires
Organization:

Study Overview

Official Title: Hemoglobin A1c and Immediate Postsurgical Complications Diabetes Type 2 (HbA1c)
Status: COMPLETED
Status Verified Date: 2019-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: HbA1c
Brief Summary: The purpose of this study is to evaluate Hemoglobin A1c values previous to a surgery in patients with diabetes type II and the complication incidence in immediate post surgery.
Detailed Description: 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.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: