A Study to Assess the Effect of a 3-month Folate Supplementation on Systemic Homocysteine Plasma Concentration and Ocular Blood Flow in Patients With Diabetes

NCT03997032 | Completed

• 1 other identifier: 23022017
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

There is evidence that a folate deficiency - and as the biological consequence of the latter - higher homocysteine plasma levels are associated with an increased risk of vascular associated diseases. For the eye, it has been shown that higher intake of folate reduces the risk of vascular related diseases such as age related macular degeneration. Further studies suggest that decreased serum levels of folate and vitamin B12 may be an independent risk factor for diabetic retinopathy. The reason for the association of low folate levels and the increased risk for vascular-associated ocular diseases is not entirely clear but may be at least partially related to an impairment of local blood flow regulation in these patients. Whether supplementation with folate may improve vascular regulation has not yet been sufficiently investigated. However, given that the potential effect size of a folate substitution on blood flow and systemic blood parameters is unclear, a proper statistical design for a large, controlled, randomized study is difficult. Thus, the present pilot study should (1) provide information about the homocysteine lowering potential of the formulation under study and (2) identify potential vascular related outcome parameters for further, larger, placebo-controlled studies and provide sufficient data to allow for a proper statistical planning for such a study. Consequently, the current study seeks to investigate the effect of a 3-month supplementation with folate on systemic homocysteine plasma levels. Further, ocular blood flow and endothelial function in the ocular microcirculation will be assessed. For this purpose, a group of 25 patients with diabetes mellitus will be included in the study. Outcome parameters will be assessed at baseline and after a 3-month supplementation with folate.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Plasma homocysteine level

  Laboratory analysis for plasma homocysteine level in µmol/L

  Change from Baseline plasma homocysteine level at 3 months

Secondary Outcomes (2)

• Retinal blood flow

  Change from Baseline retinal blood flow at 3 months

• Retinal vessel diameters

  Change from Baseline retinal vessel diameters at 3 months

Other Outcomes (1)

• Intraocular pressure

  Change from Baseline intraocular pressure at 3 months

Study Arms (1)

Patients with Diabetes

EXPERIMENTAL

Patients with Type 1 or Type 2 Diabetes

Dietary Supplement: Ocufolin

Interventions

Ocufolin DIETARY_SUPPLEMENT

Ocufolin, Aprofol AG, Switzerland Dose: 1 capsule per day

Patients with Diabetes

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Diabetes mellitus type 1 or 2
• No or mild non-proliferative diabetic retinopathy
• Normal findings in the medical history except diabetes unless the investigator considers an abnormality to be clinically irrelevant
• Normal ophthalmic findings except mild non-proliferative retinopathy
• Ametropy ≤ 6 diopters

You may not qualify if:

• Participation in a clinical trial in the 3 weeks preceding the screening visit
• Symptoms of a clinically relevant illness in the 3 weeks before the first study day
• Presence or history of a severe medical condition relevant to the study, except diabetes, as judged by the clinical investigator
• Intake of dietary supplements containing folate within the three months before the screening visit
• Untreated or uncontrolled arterial hypertension (defined as either systolic blood pressure \>150 mmHg or diastolic blood pressure \>95 mmHg)
• Blood donation during the previous three weeks
• Moderate to severe non-proliferative or proliferative diabetic retinopathy
• Previous laser photocoagulation treatment
• History or family history of epilepsy
• Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
• Best corrected visual acuity \< 0.8 Snellen
• Ametropy \> 6 Dpt
• Pregnancy, planned pregnancy or lactating

Sponsors & Collaborators

• Medical University of Vienna: lead
• Aprofol AG: collaborator

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• Schmidl D, Howorka K, Szegedi S, Stjepanek K, Puchner S, Bata A, Scheschy U, Aschinger G, Werkmeister RM, Schmetterer L, Garhofer G. A pilot study to assess the effect of a three-month vitamin supplementation containing L-methylfolate on systemic homocysteine plasma concentrations and retinal blood flow in patients with diabetes. Mol Vis. 2020 Apr 24;26:326-333. eCollection 2020.

  PMID: 32355442 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Ocufolin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 25, 2019
• Study Start: July 31, 2017
• Primary Completion: March 12, 2018
• Study Completion: July 17, 2018
• Last Updated: June 25, 2019

Record last verified: 2019-06

Locations

AU (1)