Comparison of Aqueous and Plasma Glucose Level in Diabeti... | NCT02750098

Studies
Comparison of Aqueous and Plasma Glucose Level in Diabetic Patients

NCT02750098

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Apr 25, 2016Estimated

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Diabetes Mellitus

Interventions

Glucose measurement

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

Dec 2017Estimated

Completion Date

Mar 2018Estimated

First Submitted Date

Apr 11, 2016

First Submission Date that Met QC Criteria

Apr 20, 2016

First Posted Date

Apr 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2016

Last Update Posted Date

Apr 25, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Irina Barequet, Cornea and refractive surgery specialist, Sheba Medical CenterPrincipal Investigator

Lead Sponsor

Sheba Medical CenterOTHER_GOV

Collaborators

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diabetic patients	Experimental	Diabetic patients planned to undergo elective cataract surgery	Other: Glucose measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glucose measurement	Other	Elective cataract surgery Blood glucose measurement - glucometer Aqueous humor glucose measurement - at beginning of cataract surgery - glucometer Perioperative Hemoglobin A1c level - blood laboratory test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Aqueous humor glucose concentration		Day of cataract surgery

Secondary Outcomes

Measure	Description	Time Frame
Plasma glucose concentrations		Day of cataract surgery
Hemoglobin A1c		Perioperative month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lior Lipsky, MD	Contact	972-52-7360416		lior.lipsky@gmail.com
Irit Barequet, MD	Contact			ibarequet@yahoo.com

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D002386	Cataract

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided