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HbA1c: Hemoglobin A1c and Immediate Postsurgical Complications Diabetes Type 2

Sponsor
Hospital Italiano de Buenos Aires (Other)
Overall Status
Completed
CT.gov ID
NCT01403961
Collaborator
(none)
1,760
Enrollment
1
Location
77
Actual Duration (Months)
22.8
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase

    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
    Actual Enrollment :
    1760 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Hemoglobin A1c and Immediate Postsurgical Complications Diabetes Type 2 (HbA1c)
    Actual Study Start Date :
    Jul 1, 2011
    Actual Primary Completion Date :
    Dec 1, 2016
    Actual Study Completion Date :
    Dec 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    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 [30 days postsurgery]

      Incidence of death, infections, cardiovascular o brainvascular disease

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Locations

    Site City State Country Postal Code
    1 Hospital Italiano de Buenos Aires Buenos Aires Argentina C1181ACH

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Diego Hernan Giunta, MD, MD, Hospital Italiano de Buenos Aires
    ClinicalTrials.gov Identifier:
    NCT01403961
    Other Study ID Numbers:
    • 1439
    First Posted:
    Jul 27, 2011
    Last Update Posted:
    Aug 13, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2
    Postoperative Complications

    Study Results

    No Results Posted as of Aug 13, 2019