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CompletedNCT01403961HbA1cUpdated Aug 13, 2019

Hemoglobin A1c and Immediate Postsurgical Complications Diabetes Type 2

An observational study in Postoperative Complications, sponsored by Hospital Italiano de Buenos Aires. Completed at 1 site in Argentina. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-13.

Sponsored by Hospital Italiano de Buenos Aires · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,760
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Postoperative Complications
03

In context

Postoperative Complications

1,269 studies on the registry are indexed under Postoperative Complications; 299 are open to participants now.

This study's enrollment of 1,760 is above the median of 251 across 531 observational studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

Hospital Italiano de Buenos Aires is the lead sponsor of 133 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

adult diabetic patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,760 participants (actual)

Groups and cohorts

  • HbA1c > 7

    Diabetic patients with HbA1c \> 7

  • HbA1c ≤ 7

    Diabetic patients with HbA1c ≤ 7

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 30 days postsurgery

07

Study locations

1 site
  • Hospital Italiano de Buenos Aires
    Buenos Aires, C1181ACH, Argentina
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2011 to primary completion in Dec 2016, 65 months.

Of 266 non-industry observational studies under Postoperative Complications, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's 65 months is above that.

Counting every sponsor, half of 270 studies reached it within 23 months; a quarter within 11 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 26, 2011
First posted
Jul 27, 2011
StartActual
Jul 2011
Primary completionActual
Dec 2016
CompletionActual
Dec 2017
Last update
Aug 13, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01403961
Responsible party
Diego Hernan Giunta, MD (MD, Hospital Italiano de Buenos Aires) — Principal investigator
First posted
Jul 27, 2011
Start date
Jul 2011
Primary completion
Dec 2016
Completion
Dec 2017
Last update
Aug 13, 2019

Study contacts

Diego Giunta, MD
principal investigator · AIMI. HIBA.
Javier GIunta, MD
study director · HIBA
Carlos Bonofiglio, MD
study chair · HIBA
Leon Litwak, MD
study chair · HIBA

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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