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Comparison of Aqueous and Plasma Glucose Level in Diabetic Patients

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ClinicalTrials.gov Identifier: NCT02750098
Recruitment Status : Unknown
Verified April 2016 by Prof. Irina Barequet, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 25, 2016
Last Update Posted : April 25, 2016
Sponsor:
Information provided by (Responsible Party):
Prof. Irina Barequet, Sheba Medical Center

Tracking Information
First Submitted Date  ICMJE April 11, 2016
First Posted Date  ICMJE April 25, 2016
Last Update Posted Date April 25, 2016
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
Aqueous humor glucose concentration [ Time Frame: Day of cataract surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
  • Plasma glucose concentrations [ Time Frame: Day of cataract surgery ]
  • Hemoglobin A1c [ Time Frame: Perioperative month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Aqueous and Plasma Glucose Level in Diabetic Patients
Official Title  ICMJE Comparison of Aqueous and Plasma Glucose Level in Diabetic Patients
Brief Summary

Comparison of aqueous and plasma glucose level in diabetic patients

High glucose concentrations in aqueous humor are thought to be related of diabetic ocular injury, including cataract and diabetic keratopathy. The primary mechanisms are nonenzymatic glycation, oxidative stress and activation of polyol pathway. However, glucose concentrations in aqueous humor of diabetic patients was only examined in a few patients in the past.

This study will compare glucose concentration in blood plasma and aqueous humor in diabetic patients undergoing cataract surgery. Perioperative Hemoglobin A1c concentrations will also be examined. Correlation between these parameters will be analyzed.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE Other: Glucose measurement
  1. Elective cataract surgery
  2. Blood glucose measurement - glucometer
  3. Aqueous humor glucose measurement - at beginning of cataract surgery - glucometer
  4. Perioperative Hemoglobin A1c level - blood laboratory test
Study Arms  ICMJE Experimental: Diabetic patients
Diabetic patients planned to undergo elective cataract surgery
Intervention: Other: Glucose measurement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 20, 2016)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- Diabetic patients planed for elective cataract surgery

Exclusion Criteria:

  • s/p traumatic eye injury
  • past or current uveitis
  • patients using prescription eye drops except lubricants
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02750098
Other Study ID Numbers  ICMJE 296416
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Irina Barequet, Sheba Medical Center
Study Sponsor  ICMJE Sheba Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sheba Medical Center
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP