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

• Status: Withdrawn
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Tuebingen
• Treatments: Metformin

Criteria

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