Clinical trial NCT04079660: Glycemic Control Based on Serum Fructosamine Concentration vs. hemoglobinA1c (HbA1c) in Diabetic Patients
Official title: Prospective, Observational Study Evaluating the Glycemic Control Based on Serum Fructosamine Concentration vs. hemoglobinA1c (HbA1c) in Diabetic Patients Undergoing Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: hemoglobinA1c
serum fructosamine
glycemic control
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic patients sover 18 years of age, scheduled to undergo surgery

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.

Eligibility criteria: 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)

Primary outcomes:
measure: fasting capillary blood glucose level
timeFrame: 1 hour
Secondary outcomes:
measure: hypoglycemia
timeFrame: 1 day
measure: hyperglycemia
timeFrame: 1 day
measure: infection
timeFrame: 1 day
measure: wound healing
timeFrame: 1 day
measure: delirium
timeFrame: 1 day
measure: reoperation
timeFrame: 1 day
measure: LOS
timeFrame: 1 day
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
References:
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