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The Relationship Between Stage of Diabetic Retinopathy and Retinal Blood Flow in Patients With IDDM During Euglycemic Clamp
Plain-language guide to NCT00814008: phase 2 non-randomized trial of Insulin (regular human), diabetic retinopathy and glaucoma, 64 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00814008
- Phase
- phase 2
- Status
- completed
- Start
- 1999-03
- Completion (planned or actual)
- 2000-04
- Participants
- 64 (estimated)
- Design
- non-randomized, open label (everyone knows who gets what), diagnostic
- Conditions studied
- Diabetes Mellitus, Type 1; Insulin; Retina; Regional Blood Flow
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Insulin (regular human) for diabetic retinopathy and glaucoma.
Impaired retinal blood flow has been implicated in the pathogenesis of diabetic retinopathy.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 64 planned participants were the target.
It was open to people of any sex aged from 19 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Age \>= 19 years. Best corrected visual acuity \>= 0.8. Ametropia \< 6 dpt. Age and sex matched to the subjects in the patients group. Best corrected visual acuity \>= 0.8.
The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: presence of intraocular pathology other than diabetic retinopathy (for example: cataract, glaucoma, ocular hypertension); hypertension (systolic blood pressure \> 160 mm hg or diastolic blood pressure \> 90 mm hg); previous laser photocoagulation treatment.
How the Study Was Run
The set-up was non-randomized, parallel-group and open-label.
The Insulin (regular human) group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Insulin (regular human) study: the diabetic retinopathy and glaucoma participants and staff both knew the treatment.
It started in 1999-03 with completion listed for 2000-04.
It ran at 1 site in Austria.
Its stated primary purpose is diagnostic.
What Was Measured
Primary outcome: retinal blood flow after 1 hour of insulin clamp (time frame: 2 x 2 minutes).
It also tracked 1 secondary outcome, for example Mean blood velocities in ophthalmic artery, posterior ciliary arteries and central retinal artery after 1 hour of insulin clamp.
What This Means in Plain Language
Put simply, this is a phase 2, non-randomized trial of Insulin (regular human) in 64 people with diabetic retinopathy and glaucoma.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin (regular human) compound page, Diabetic retinopathy and glaucoma research.
Our Notes on the Compound
Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.