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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04079660
Enrollment
50
Registered
2019-09-06
Start date
2021-02-01
Completion date
2021-02-01
Last updated
2021-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

hemoglobinA1c, serum fructosamine, glycemic control

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.

Interventions

DIAGNOSTIC_TESTCapillary 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

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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)

Design outcomes

Primary

MeasureTime frameDescription
fasting capillary blood glucose level1 hourAssociation between pre-operative HbA1c and fructosamine with pre-operative, fasting capillary blood glucose level measured the morning of surgery in preoperative holding area.

Secondary

MeasureTime frameDescription
hyperglycemia1 dayii. Incidence of hyperglycemia, defined as CBG \> 180 mg/dL, during the perioperative period
infection1 dayIncidence of wound infection
wound healing1 dayIncidence of poor wound healing
hypoglycemia1 dayi. Incidence of hypoglycemia, defined as CBG \< 70 mg/dL, during the perioperative period
reoperation1 dayIncidence of reoperation procedure
LOS1 dayLength of PACU stay
delirium1 dayIncidence of post-operative delirium

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026