Glycemic Control Based on Serum Fructosamine Concentration vs. hemoglobinA1c (HbA1c) in Diabetic Patients

September 21, 2021 updated by: Barbara Rogers, Ohio State University

Prospective, Observational Study Evaluating the Glycemic Control Based on Serum Fructosamine Concentration vs. hemoglobinA1c (HbA1c) in Diabetic Patients Undergoing Surgeries

Diabetes mellitus is associated with negative outcomes in patients undergoing surgery. Blood sugar levels are monitored by measuring a values that include but are not limited to hemoglobin A1c, capillary blood glucose, and fructosamine . This study is being done to investigate if there is an associated between these values and postsurgical outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to compare the predictive capacity of both fructosamine and HbA1c on preoperative basal glucose level, as well as adverse events (cardiovascular events, surgical site infection, and mortality) and length of post-anesthesia care unit (PACU) stay in both Type I and Type II diabetic patients. Secondary outcomes include length of anesthesia administration, an indicator of intraoperative complications, and perioperative glucose level.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diabetic patients sover 18 years of age, scheduled to undergo surgery

Description

Inclusion Criteria:

  1. Male or female patients able to consent.
  2. Patients with either Type I or Type II diabetes mellitus (DM)
  3. Patients undergoing non-cardiac surgeries under general anesthesia
  4. ≥ 18 years of age

Exclusion Criteria:

  1. Inability to read, understand or sign the consent form
  2. End-stage renal disease
  3. Special populations (Incarcerated individuals, pregnant female patients)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical patients
Diabetic patients scheduled to undergo non-cardiac surgery
Diagnostic test: Capillary blood glucose blood draw
Capillary blood glucose (CBG), HbA1c, fructosamine, albumin, BUN, and creatinine values will be obtained from a blood draw as a standard of care
Other Names:
  • CBG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fasting capillary blood glucose level
Time Frame: 1 hour
Association between pre-operative HbA1c and fructosamine with pre-operative, fasting capillary blood glucose level measured the morning of surgery in preoperative holding area.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hypoglycemia
Time Frame: 1 day
i. Incidence of hypoglycemia, defined as CBG < 70 mg/dL, during the perioperative period
1 day
hyperglycemia
Time Frame: 1 day
ii. Incidence of hyperglycemia, defined as CBG > 180 mg/dL, during the perioperative period
1 day
infection
Time Frame: 1 day
Incidence of wound infection
1 day
wound healing
Time Frame: 1 day
Incidence of poor wound healing
1 day
delirium
Time Frame: 1 day
Incidence of post-operative delirium
1 day
reoperation
Time Frame: 1 day
Incidence of reoperation procedure
1 day
LOS
Time Frame: 1 day
Length of PACU stay
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

September 3, 2019

First Submitted That Met QC Criteria

September 3, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018H0320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No IPD will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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