WithdrawnPhase 2

Treatment of Bardet-Biedl-Syndrome With Metformin for Evaluation of a Possible Visual Improvement

Stopped: unrealizable wishes of national authorities

0Started 2018-04-01

Plain-language summary

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.

Who can participate

Age range10 Years – 25 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * clinically confirmed Bardet-Biedl-syndrome * Visual acuity between 0.05 and 0.8 * Age \>=10 year to \<25 years * Visual field III4e or V4e with diameter \>=5°, if II4e not seen * informed consent of patient and/or legal representative Exclusion Criteria: * Hypoglycaemia (\<50mg/dl) * Therapy with Metformin within the last three months * Participation in another clinical trial * pregnancy, lactation * any contra indication concerning Metformin therapy * Renal failure (creatinine clearance \< 60ml/min) * any acute disorder accompanied by clouding of consciousness * acute or chronic disorders possible accompanied by tissue hypoxia * Liver insufficiency, alcohol abuse * not fluent in German language

What they're measuring

Visual acuity

Timeframe: Baseline to day 210

Trial details

NCT IDNCT03490019

SponsorUniversity Hospital Tuebingen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10

View on ClinicalTrials.gov More Bardet-Biedl Syndrome trials