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

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ClinicalTrials.gov Identifier: NCT04120077
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
ZeaVision, LLC

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Diabetic Retinopathy Dietary Supplement: EyePromise DVS, EyePromise DVS plus EyePromise EZTears Not Applicable

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™).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: KNOC OUT DIABETES: Combined Effects of Diabetes Self-Management Education and Nutritional Supplementation on Visual Function and Retinopathy
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: DSME + placebo supplement (group 1)
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
Placebo Comparator: American Association of Diabetes Educators (AADE) certified Diabetes Self-Management Education (DSME) with placebo nutritional supplements

Experimental: DSME + DVS supplement (group 2)
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
Placebo Comparator: American Association of Diabetes Educators (AADE) certified Diabetes Self-Management Education (DSME) with placebo nutritional supplements

Experimental: DSME + DVS supplement + omega-3 supplement (group 3)
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
Placebo Comparator: American Association of Diabetes Educators (AADE) certified Diabetes Self-Management Education (DSME) with placebo nutritional supplements




Primary Outcome Measures :
  1. full-field flicker electroretinogram (ffERG) implicit time (milliseconds) [ Time Frame: Change from baseline to 12 months ]
    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

  2. full-field flicker electroretinogram (ffERG) amplitude (microvolts) [ Time Frame: Change from baseline to 12 months ]
    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

  3. glycosylated hemoglobin (HbA1c) percentage [ Time Frame: Change from baseline to 12 months ]
    HbA1c is a measure of mean blood glucose over a 8-12 week duration and requires a simple fingerstick blood draw.


Secondary Outcome Measures :
  1. Diabetic Retinopathy Severity using International Diabetic Retinopathy Severity Scale (DRSS) [ Time Frame: Change comparing Baseline to 12 months ]
    Photographic analysis of the retinal fundus will be conducted to assess severity at baseline and 12 months according to the DRSS: No retinopathy, mild non-proliferative retinopathy, moderate non-proliferative retinopathy, severe non-proliferative retinopathy, proliferative retinopathy

  2. body mass index (BMI) Kg/meter(squared) [ Time Frame: Change comparing Baseline to 12 months ]
    patient height and weight will be assessed to calculate BMI at baseline and 12 months

  3. Ocular Surface Disease Index Score (OSDI) [ Time Frame: Change comparing Baseline score and score at 12 months ]
    A validated questionnaire regarding symptoms of ocular dryness rated on a scale of 0 to 100, with higher scores representing more severe symptoms of dry eye

  4. Color Contrast Threshold Sensitivity (minimal percentage contrast detection for each pre-specified wavelength) [ Time Frame: Change comparing Baseline and 12 months ]
    Extended color vision analysis yielding quantitative measurement of short, medium and long wavelength cone photoreceptor function will be obtained by having subjects ascertain the direction of a Landolt C target (up, down, left, right) of decreasing contrast, using a commercially available color vision testing device (ColorDx Chromatic Contrast Threshold testing, Konan Medical, Irvine, CA);


Other Outcome Measures:
  1. Macular pigment optical density (MPOD) in relative density units [ Time Frame: Change comparing Baseline and 12 months ]
    measurement of macular pigment optical density (MPOD) using heterochromic flicker photometry with a commercially available device (QuantifEye, ZeaVision, LLC, Chesterfield, MO). Subjects are asked to respond when they detect a flickering stimulus .



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04120077


Contacts
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Contact: Paula R. Newsome, OD (704) 375-3935 paulanews@aol.com
Contact: Ansel T. Johnson, OD (708) 385-0013 nfo@visionsalon.com

Locations
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United States, North Carolina
Advantage Vision Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Paula R. Newsome, OD    704-375-3935    paulanews@aol.com   
Contact: Tempest Bryant    704-375-3935    appts@advantagevisioncenter.com   
Sponsors and Collaborators
ZeaVision, LLC

Publications of Results:
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Responsible Party: ZeaVision, LLC
ClinicalTrials.gov Identifier: NCT04120077     History of Changes
Other Study ID Numbers: KNOC-001
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Complications
Retinal Diseases
Diabetic Retinopathy
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases