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

University Hospital Tuebingen

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Bardet-Biedl Syndrome Visual Impairment

Interventions

MetforminDRUG

500, 850 or 1000 mg depending on body weight once daily for 24 weeks

Eligibility

Sex: ALLMin age: 10 YearsMax age: 25 Years

Medical Language ↔ Plain English

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