Clinical trial NCT04120077: Combined Effects of Diabetes Self-Management Education and Nutritional Supplementation on Visual Function and Retinopathy
Official title: KNOC OUT DIABETES: Combined Effects of Diabetes Self-Management Education and Nutritional Supplementation on Visual Function and Retinopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Diabetic Retinopathy
Lead sponsor: ZeaVision, LLC
Sponsor class: INDUSTRY
First posted: 2019-10-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel intervention to assess changes in metabolic control, diabetic retinopathy status and patient knowledge with diabetes self-management education (DSME) in isolation, DSME combined with DVS supplement, or DSME combined with both DVS supplement and omega-3 based supplement (EZTears)
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the combined effects of diabetes self-management education (DSME) and nutritional supplementation on visual function and retinopathy incidence \& progression in patients with type 1 diabetes, type 2 diabetes and pre-diabetes.

Detailed description: This will be an investigator initiated, multi-center, double-blinded prospective study of 150-200 adult subjects with established prediabetes or diabetes. Subjects will be identified and enrolled with informed consent from 4 private optometric practices in the Southeastern and Central United States. Enrollment in the diabetes self-management education (DSME) component of the study will be requisite for participation in the trial and DSME will be provided by designated study investigators trained to deliver AADE7™ curricula in individual and/or group settings. Subjects will be randomized to DSME in isolation or in combination with one of two nutritional supplementation arms of the trial (described below). Supplements will be provided by ZeaVision, LLC of Chesterfield, MO.

Subjects will undergo initial KNOC out Diabetes™ visits with assessment of current diabetes status and provision of DSME curriculum, with follow-up DSME assessments and goal reporting at 1-month, 3-months, 6-months, 9-months and 12-months. Subjects will receive comprehensive dilated eye examinations with additional tests of visual function (described below) at baseline, 3 months, 6 months and 12 months.

KNOC out Diabetes™ is a 10-session, diabetes self-management education program designed to improve patient behaviors and blood glucose over a 12 month period and delivered by doctors of optometry. KNOC is an acronym for "Knowledge, Nutrition, Ocular Health and Coaching. The program features weekly internet learning, experiential learning focused on solving specific, individualized patient diabetes management problems, weekly phone coaching Test nutritional supplements will be: (1) a multi-component formula (EyePromise DVS™) (2) a high-potency marine-sourced omega-3 polyunsaturated fatty acid supplement (EyePromise EZTears™).

Eligibility criteria: Inclusion Criteria:

* diagnosed prediabetes, type 1 or type 2 diabetes
* no diabetic retinopathy (DR), mild DR or moderate DR without center-involved macular edema
* age \> 18 years
* ability to give informed consent
* best corrected visual acuity \> 20/30 in each eye.

Exclusion Criteria:

* no formal diagnosis of prediabetes or diabetes
* age \< 18 years
* inability to give informed consent
* best corrected visual acuity \< 20/30 in either eye
* center-involved DME by spectral domain optical coherence tomography \* evidence of severe non-proliferative or proliferative diabetic retinopathy
* evidence of other serious ocular disease (age-related macular degeneration, glaucoma, significant media opacity)
* history of intraocular surgery, including macular or panretinal photocoagulation or prior intra-ocular injection of anti-Vascular endothelial growth factor (anti-VEGF) drugs (except uncomplicated cataract or keratorefractive surgery more than 6 months prior to enrollment)
* pregnant and nursing women
* known sensitivity to any of the supplement ingredients.

Primary outcomes:
measure: full-field flicker electroretinogram (ffERG) implicit time (milliseconds)
timeFrame: Change from baseline to 12 months
measure: full-field flicker electroretinogram (ffERG) amplitude (microvolts)
timeFrame: Change from baseline to 12 months
measure: glycosylated hemoglobin (HbA1c) percentage
timeFrame: Change from baseline to 12 months
Secondary outcomes:
measure: Diabetic Retinopathy Severity using International Diabetic Retinopathy Severity Scale (DRSS)
timeFrame: Change comparing Baseline to 12 months
measure: body mass index (BMI) Kg/meter(squared)
timeFrame: Change comparing Baseline to 12 months
measure: Ocular Surface Disease Index Score (OSDI)
timeFrame: Change comparing Baseline score and score at 12 months
measure: Color Contrast Threshold Sensitivity (minimal percentage contrast detection for each pre-specified wavelength)
timeFrame: Change comparing Baseline and 12 months
Other outcomes:
measure: Macular pigment optical density (MPOD) in relative density units
timeFrame: Change comparing Baseline and 12 months
Locations:
city: Charlotte
country: United States
facility: Advantage Vision Center
state: North Carolina
Study officials:
References:
citation: Chous AP, Richer SP, Gerson JD, Kowluru RA. The Diabetes Visual Function Supplement Study (DiVFuSS). Br J Ophthalmol. 2016 Feb;100(2):227-34. doi: 10.1136/bjophthalmol-2014-306534. Epub 2015 Jun 18.