Combined Effects of Diabetes Self-Management Education and Nutritional Supplementation on Visual Function and Retinopathy

ZeaVision

Status: Unknown

Conditions: Diabetes Mellitus; Diabetic Retinopathy

Treatments: Dietary Supplement: EyePromise DVS, EyePromise DVS plus EyePromise EZTears

Study type: Interventional

Funder types: Industry

Identifiers

NCT04120077

KNOC-001

Details and patient eligibility

About

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.

Full 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™).

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups, including a placebo group

DSME + placebo supplement (group 1)

Placebo Comparator group

Description:

Subjects will receive 10-session DSME delivered in a group setting by their optometrist. Subjects be instructed to consume two capsules (canola oil soft-gels) per day in the morning and two capsules per day in the evening along with food and six to eight ounces of water, and continue their normal dietary, exercise and medication regimens. Baseline and 3,6,9, 12-month assessments of color perception, 10-degree visual field, flicker electroretinogram (ffERG), glycosylated hemoglobin, diabetic retinopathy severity and optical coherence tomography/optical coherence tomography angiography (OCT/OCTA) parameters will be assessed. Serum vitamin D, glycohemoglobin and high-sensitivity C-reactive protein (hsCRP) and macular pigment density will be assessed at baseline, 6 and 12 months.

Treatment:

Dietary Supplement: EyePromise DVS, EyePromise DVS plus EyePromise EZTears

DSME + DVS supplement (group 2)

Experimental group

Description:

Subjects will receive 10-session DSME delivered in a group setting by their optometrist. Subjects will be instructed to consume two capsules per day (EyePromise DVS nutritional supplement) in the morning and two capsules per day (canola oil placebo) in the evening along with food and six to eight ounces of water, and continue their normal dietary, exercise and medication regimens. Baseline and 3,6,9, 12-month assessments of color perception, 10-degree visual field, flicker electroretinogram (ffERG), glycosylated hemoglobin, diabetic retinopathy severity and optical coherence tomography/optical coherence tomography angiography (OCT/OCTA) parameters will be assessed. Serum vitamin D, glycohemoglobin and high-sensitivity C-reactive protein (hsCRP) and macular pigment density will be assessed at baseline, 6 and 12 months.

Treatment:

Dietary Supplement: EyePromise DVS, EyePromise DVS plus EyePromise EZTears

DSME + DVS supplement + omega-3 supplement (group 3)

Experimental group

Description:

Subjects will receive 10-session DSME delivered in a group setting by their optometrist. Subjects will be instructed to consume two capsules per day (EyePromise DVS nutritional supplement) in the morning and two capsules per day (EyePromise EZTears) in the evening along with food and six to eight ounces of water, and continue their normal dietary, exercise and medication regimens. Baseline and 3,6,9, 12-month assessments of color perception, 10-degree visual field, flicker electroretinogram (ffERG), glycosylated hemoglobin, diabetic retinopathy severity and optical coherence tomography/optical coherence tomography angiography (OCT/OCTA) parameters will be assessed. Serum vitamin D, glycohemoglobin and high-sensitivity C-reactive protein (hsCRP) and macular pigment density will be assessed at baseline, 6 and 12 months.

Treatment:

Dietary Supplement: EyePromise DVS, EyePromise DVS plus EyePromise EZTears