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

NCT04120077 | Unknown DMC

• 1 other identifier: KNOC-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Diabetic Retinopathy

Outcome Measures

Primary Outcomes (3)

• full-field flicker electroretinogram (ffERG) implicit time (milliseconds)

  The Flicker ERG will be recorded using a commercially available system, (RetEval, Konan Medical, Irvine, CA). The test will be performed in an illuminated room, free of visual and audible distractions. Subjects will be instructed to fixate on a target using the fellow eye (eye not been tested) and results will be consecutively recorded from both eyes by means of skin electrodes

  Change from baseline to 12 months

• full-field flicker electroretinogram (ffERG) amplitude (microvolts)

  The Flicker ERG will be recorded using a commercially available system, (RetEval, Konan Medical, Irvine, CA). The test will be performed in an illuminated room, free of visual and audible distractions. Subjects will be instructed to fixate on a target using the fellow eye (eye not been tested) and results will be consecutively recorded from both eyes by means of skin electrodes

  Change from baseline to 12 months

• glycosylated hemoglobin (HbA1c) percentage

  HbA1c is a measure of mean blood glucose over a 8-12 week duration and requires a simple fingerstick blood draw.

  Change from baseline to 12 months

Secondary Outcomes (4)

• Diabetic Retinopathy Severity using International Diabetic Retinopathy Severity Scale (DRSS)

  Change comparing Baseline to 12 months

• body mass index (BMI) Kg/meter(squared)

  Change comparing Baseline to 12 months

• Ocular Surface Disease Index Score (OSDI)

  Change comparing Baseline score and score at 12 months

• Color Contrast Threshold Sensitivity (minimal percentage contrast detection for each pre-specified wavelength)

  Change comparing Baseline and 12 months

Other Outcomes (1)

• Macular pigment optical density (MPOD) in relative density units

  Change comparing Baseline and 12 months

Study Arms (3)

DSME + placebo supplement (group 1)

PLACEBO COMPARATOR

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.

Dietary Supplement: EyePromise DVS, EyePromise DVS plus EyePromise EZTears

DSME + DVS supplement (group 2)

EXPERIMENTAL

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.

Dietary Supplement: EyePromise DVS, EyePromise DVS plus EyePromise EZTears

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

EXPERIMENTAL

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.

Dietary Supplement: EyePromise DVS, EyePromise DVS plus EyePromise EZTears

Interventions

EyePromise DVS, EyePromise DVS plus EyePromise EZTears DIETARY_SUPPLEMENT

Placebo Comparator: American Association of Diabetes Educators (AADE) certified Diabetes Self-Management Education (DSME) with placebo nutritional supplements

DSME + DVS supplement (group 2); DSME + DVS supplement + omega-3 supplement (group 3); DSME + placebo supplement (group 1)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ZeaVision, LLC: lead

Study Sites (1)

Advantage Vision Center

Charlotte, North Carolina, 28203, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 26089210 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications

Central Study Contacts

Paula R. Newsome, OD

CONTACT

(704) 375-3935; paulanews@aol.com

Ansel T. Johnson, OD

CONTACT

(708) 385-0013; nfo@visionsalon.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Bottle sets (three bottles per set) of the two nutritional supplements and identically packaged placebo will be coded by number and randomly assigned by the supplement manufacturer (ZeaVision, LLC, Chesterfield, MO) to enrolled subjects and distributed at co-investigators' offices. All investigators and enrolled subjects will be naïve as to subjects' supplement/placebo status throughout the study period and during all data analysis by an independent bio-statistician. Subjects will be randomly assigned to take either placebo (group 1), EyePromise DVS™ (group 2) or EyePromise DVS™ combined with EyePromise EZTears™ (group 3) in a ratio of 1:1:1.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 9, 2019
• Study Start: January 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)