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

Completed

• Conditions: Diabetes

• Registration Number: NCT04079660
• Lead Sponsor: Ohio State University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2019-09-03
• Study First Submitted QC: 2019-09-03
• Study First Posted: 2019-09-06
• Study Start: 2021-02-01
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fasting capillary blood glucose level	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States