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

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ClinicalTrials.gov Identifier: NCT04079660
Recruitment Status : Active, not recruiting
First Posted : September 5, 2019
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Barbara Rogers, Ohio State University

Tracking Information
First Submitted Date September 3, 2019
First Posted Date September 5, 2019
Last Update Posted Date September 5, 2019
Actual Study Start Date July 1, 2019
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 3, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 3, 2019)
  • hypoglycemia [ Time Frame: 1 day ]
    i. Incidence of hypoglycemia, defined as CBG < 70 mg/dL, during the perioperative period
  • hyperglycemia [ Time Frame: 1 day ]
    ii. Incidence of hyperglycemia, defined as CBG > 180 mg/dL, during the perioperative period
  • infection [ Time Frame: 1 day ]
    Incidence of wound infection
  • wound healing [ Time Frame: 1 day ]
    Incidence of poor wound healing
  • delirium [ Time Frame: 1 day ]
    Incidence of post-operative delirium
  • reoperation [ Time Frame: 1 day ]
    Incidence of reoperation procedure
  • LOS [ Time Frame: 1 day ]
    Length of PACU stay
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Diabetic patients sover 18 years of age, scheduled to undergo surgery
Condition Diabetes
Intervention 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 Name: CBG
Study Groups/Cohorts Surgical patients
Diabetic patients scheduled to undergo non-cardiac surgery
Intervention: Diagnostic Test: Capillary blood glucose blood draw
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: September 3, 2019)
50
Original Actual Enrollment Same as current
Estimated Study Completion Date December 15, 2020
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04079660
Other Study ID Numbers 2018H0320
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: No IPD will be shared.
Responsible Party Barbara Rogers, Ohio State University
Study Sponsor Ohio State University
Collaborators Not Provided
Investigators Not Provided
PRS Account Ohio State University
Verification Date September 2019