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

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ClinicalTrials.gov Identifier: NCT01403961
Recruitment Status : Recruiting
First Posted : July 27, 2011
Last Update Posted : November 10, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
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 Design

Study Type : Observational
Estimated Enrollment : 1760 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hemoglobin A1c and Immediate Postsurgical Complications Diabetes Type 2 (HbA1c)
Study Start Date : July 2011
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Compare incidence of immediate post surgery complications in diabetic patients with HbA1c > 7 and patients with HbA1c ≤ 7 [ Time Frame: 30 days postsurgery ]
    Incidence of death, infections, cardiovascular o brainvascular disease


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Diego Hernan Giunta, MD, MD, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT01403961     History of Changes
Other Study ID Numbers: 1439
First Posted: July 27, 2011    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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