A Phase 2 interventional study of Metformin in Bardet-Biedl Syndrome and Visual Impairment, sponsored by University Hospital Tuebingen. Withdrawn. Open to participants aged 10 Years to 25 Years. Per ClinicalTrials.gov, last updated 2019-04-18.
Sponsored by University Hospital Tuebingen · Phase 2, Interventional, and Treatment
In this prospective pilot study without control group children and young adults (10-25 years old) diagnosed with Bardet-Biedl syndrome and treated with Metformin for their adipositas will be evaluated for a possible additional effect of Metformin on visual acuity.
Within experiments with animals a positive effect of Metformin concerning the photo receptors was shown. Several patients of the university hospital Tübingen with Bardet-Biedl-Syndrome and Metformin therapy due to their adipositas reported a subjective improvement of the visual acuity which was confirmed by opthalmologic tests.
This will be checked in a prospective pilot study without control group including children and young adults (10-25 years old) diagnosed with Bardet-Biedl syndrome and treated with Metformin for their adipositas. Therefore a possible additional effect of Metformin on visual acuity will be evaluated under controlled conditions.
360 studies on the registry are indexed under Vision Disorders; 84 are open to participants now.
Browse Vision Disorders studies →University Hospital Tuebingen is the lead sponsor of 490 studies on the registry; 108 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metformin therapy once daily for 24 weeks with a dose of 500, 850 or 1000 mg depending on body weight
Drug: Metformin
500, 850 or 1000 mg depending on body weight once daily for 24 weeks
Visual acuity
Course of visual acuity according to appropriate table
Time frame: Baseline to day 210
Number of letters read
Course visual acuity defined as number of letters read
Time frame: Baseline to day 210
Results of Static perimetry
Course of results of static perimetry given by measurement of light contrast sensitivity within at least 5 central points.
Time frame: Baseline to day 210
Results of Kinetic perimetry
Course of results of kinetic perimetry given by mapping the visual field sensitivity boundaries using Goldmann perimetry
Time frame: Baseline to day 210
Electroretinogram (ERG) dim-flash
Course of values of ERG dim-flash
Time frame: Baseline to day 210
Electroretinogram (ERG) standard flash
Course of values of ERG standard flash at 3 ods/m2
Time frame: Baseline to day 210
Electroretinogram (ERG) cone-single-flash
Course of values of ERG cone-single-flash at 30cd/m2
Time frame: Baseline to day 210
Electroretinogram (ERG) 30-Hz-Flicker
Course of values of ERG measured by 30-Hz-Flicker in all patients
Time frame: Baseline to day 210
Visual evoked potential (VEP) - amplitude
Course of results of measurement of VEP amplitude
Time frame: Baseline to day 210
Visual evoked potential (VEP) - latency time
Course of results of measurement of VEP latency time
Time frame: Baseline to day 210
FST
Full-Field-Stimulus Threshold
Time frame: Baseline to day 210
optical coherence tomography (OCT)
Course of central thickness of retina measured by OCT
Time frame: Baseline to day 210
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Apr 2018; primary completion for Oct 2019, 18 months later.
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This study is withdrawn, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Metformin
University Hospital Tuebingen →