Diabetes MellitusNCT02750098
Comparison of Aqueous and Plasma Glucose Level in Diabetic Patients
A study testing Glucose measurement in people with Diabetes Mellitus, run by Sheba Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Glucose measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic patients planed for elective cataract surgery
Who cannot join
- s/p traumatic eye injury
- past or current uveitis
- patients using prescription eye drops except lubricants
Trial locations and contacts
No sites are listed yet.
Irit Barequet, MD contact
About this study
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.
- Conditions
- Diabetes Mellitus
- Being tested
- Glucose measurement
- Keywords
- Diabetes Mellitus, Cataract, Aqueous humor
- Medical subject headings
- Diabetes Mellitus, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose measurementOther
- Elective cataract surgery
- Blood glucose measurement - glucometer
- Aqueous humor glucose measurement - at beginning of cataract surgery - glucometer
- Perioperative Hemoglobin A1c level - blood laboratory test
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients | Experimental | Diabetic patients planned to undergo elective cataract surgery Receives: Other: Glucose measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aqueous humor glucose concentration
Measured: Day of cataract surgery
Secondary outcomes (2)
Plasma glucose concentrations
Measured: Day of cataract surgery
Hemoglobin A1c
Measured: Perioperative month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Irina Barequet, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750098
- Sponsor's protocol ID
- 296416
- Status last verified
- Apr 2016
- First submitted
- 11 Apr 2016
- Last updated
- 25 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Aqueous and Plasma Glucose Level in Diabetic Patients
- ClinicalTrials.gov ID
- NCT02750098
- Acronym / sponsor ID
- 296416
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Cataract, Aqueous humor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- May 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients | Experimental | Other: Glucose measurementDiabetic patients planned to undergo elective cataract surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetic patients planed for elective cataract surgery
Key exclusion criteria (3 listed)
- s/p traumatic eye injury
- past or current uveitis
- patients using prescription eye drops except lubricants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose measurement1. 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 | Other | Diabetic patients |
Primary outcome
Aqueous humor glucose concentration
Time frame: Day of cataract surgery
2 secondary outcomes
Plasma glucose concentrations
Time frame: Day of cataract surgery
Hemoglobin A1c
Time frame: Perioperative month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irit Barequet, MD contact
Questions about this trial
What is this clinical trial studying?
A study testing Glucose measurement in people with Diabetes Mellitus, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lior Lipsky, MD (972-52-7360416, lior.lipsky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aqueous humor glucose concentration (time frame: Day of cataract surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2016.