Combined Effects of Diabetes Self-Management Education and Nutritional Supplementation on Visual Function and Retinopathy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetes Mellitus
- Diabetic Retinopathy
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
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....
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™).
Tracking Information
- NCT #
- NCT04120077
- Collaborators
- Not Provided
- Investigators
- Not Provided
Get Well Soon