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出境医 / 临床实验 / 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

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

Study Description
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.


Condition or disease Intervention/treatment Phase
Diabetes Dietary Supplement: Ocufolin Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Pilot Study to Assess the Effect of a 3-month Folate Supplementation on Systemic Homocysteine Plasma Concentration and Ocular Blood Flow in Patients With Diabetes
Actual Study Start Date : July 31, 2017
Actual Primary Completion Date : March 12, 2018
Actual Study Completion Date : July 17, 2018
Arms and Interventions
Arm Intervention/treatment
Experimental: Patients with Diabetes
Patients with Type 1 or Type 2 Diabetes
Dietary Supplement: Ocufolin
Ocufolin, Aprofol AG, Switzerland Dose: 1 capsule per day

Outcome Measures
Primary Outcome Measures :
  1. Plasma homocysteine level [ Time Frame: Change from Baseline plasma homocysteine level at 3 months ]
    Laboratory analysis for plasma homocysteine level in µmol/L


Secondary Outcome Measures :
  1. Retinal blood flow [ Time Frame: Change from Baseline retinal blood flow at 3 months ]
    Retinal blood flow will be assessed using Fourier domain optical coherence tomography, providing values in µl/min

  2. Retinal vessel diameters [ Time Frame: Change from Baseline retinal vessel diameters at 3 months ]

Other Outcome Measures:
  1. Intraocular pressure [ Time Frame: Change from Baseline intraocular pressure at 3 months ]
    Intraocular pressure will be assessed using Goldmann Applanation Tonometry, values will be provided in mmHg


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations

Locations
Layout table for location information
Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Aprofol AG
Tracking Information
First Submitted Date  ICMJE June 19, 2019
First Posted Date  ICMJE June 25, 2019
Last Update Posted Date June 25, 2019
Actual Study Start Date  ICMJE July 31, 2017
Actual Primary Completion Date March 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
Plasma homocysteine level [ Time Frame: Change from Baseline plasma homocysteine level at 3 months ]
Laboratory analysis for plasma homocysteine level in µmol/L
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • Retinal blood flow [ Time Frame: Change from Baseline retinal blood flow at 3 months ]
    Retinal blood flow will be assessed using Fourier domain optical coherence tomography, providing values in µl/min
  • Retinal vessel diameters [ Time Frame: Change from Baseline retinal vessel diameters at 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 24, 2019)
Intraocular pressure [ Time Frame: Change from Baseline intraocular pressure at 3 months ]
Intraocular pressure will be assessed using Goldmann Applanation Tonometry, values will be provided in mmHg
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE A Pilot Study to Assess the Effect of a 3-month Folate Supplementation on Systemic Homocysteine Plasma Concentration and Ocular Blood Flow in Patients With Diabetes
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Diabetes
Intervention  ICMJE Dietary Supplement: Ocufolin
Ocufolin, Aprofol AG, Switzerland Dose: 1 capsule per day
Study Arms  ICMJE Experimental: Patients with Diabetes
Patients with Type 1 or Type 2 Diabetes
Intervention: Dietary Supplement: Ocufolin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2019)
25
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 17, 2018
Actual Primary Completion Date March 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03997032
Other Study ID Numbers  ICMJE 23022017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Gerhard Garhofer, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Aprofol AG
Investigators  ICMJE Not Provided
PRS Account Medical University of Vienna
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP