Hemoglobin A1c and Immediate Postsurgical Complications Diabetes Type 2 (HbA1c)

Hemoglobin A1c and Immediate Postsurgical Complications Diabetes Type 2 (HbA1c)

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications

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 Type: Observational
• Enrollment (Actual): 1760

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1181ACH
    • Hospital Italiano de Buenos Aires

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

adult diabetic patients

Description

Inclusion Criteria

1. Patients older than 18 years with diagnosed of diabetes type 2
2. Programmed major surgery with expected hospitalization longer than 24 hours

Exclusion Criteria

1. Refusal to participate in the study or the informed consent process.
2. Programmed cardiac or coronary surgery
3. Technical complications inherent to surgical or anatomical abnormalities.
4. Pregnant women.
5. Active infection prior to performing surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HbA1c > 7; Diabetic patients with HbA1c > 7
HbA1c ≤ 7; Diabetic patients with HbA1c ≤ 7

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare incidence of immediate post surgery complications in diabetic patients with HbA1c > 7 and patients with HbA1c ≤ 7	Incidence of death, infections, cardiovascular o brainvascular disease	30 days postsurgery

Collaborators and Investigators

• Sponsor: Hospital Italiano de Buenos Aires
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2011
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: July 26, 2011
• First Submitted That Met QC Criteria: July 26, 2011
• First Posted (Estimate): July 27, 2011

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 9, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Postoperative Complications
• Other Study ID Numbers: 1439

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO