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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Hospital Italiano de Buenos Aires
Sponsor:
Information provided by (Responsible Party):
Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier:
NCT01403961
First received: July 26, 2011
Last updated: March 19, 2015
Last verified: March 2015
  Purpose

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.


Condition
Postoperative Complications

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hemoglobin A1c and Immediate Postsurgical Complications Diabetes Type 2 (HbA1c)

Resource links provided by NLM:


Further study details as provided by Hospital Italiano de Buenos Aires:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 1760
Study Start Date: July 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
HbA1c > 7
Diabetic patients with HbA1c > 7
HbA1c ≤ 7
Diabetic patients with HbA1c ≤ 7

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

adult diabetic patients

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403961

Contacts
Contact: Javier Giunta, MD +541149590200 ext 4419 javier.giunta@hospitalitaliano.org.ar

Locations
Argentina
Hospital Italiano de Buenos Aires Recruiting
Buenos Aires, Argentina, C1181ACH
Contact: Javier Giunta, MD    541149590200 ext 4419    javier.giunta@hospitalitaliano.org.ar   
Principal Investigator: Diego Giunta, MD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Diego Hernan Giunta, MD, MD, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT01403961     History of Changes
Other Study ID Numbers: 1439
Study First Received: July 26, 2011
Last Updated: March 19, 2015
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Postoperative Complications
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 28, 2015