NCT03490019

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

Treatment of Infantile and Juvenile Patients With Bardet-Biedl-Syndrome With Metformin. Evaluation of a Visual Improvement as a Side Effect of the Pediatric Treatment of Adipositas - a Prospective Pilot Study Without Control

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 10 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Bardet-Biedl Syndrome
• Visual Impairment

Interventions

Type	Name	Description
DRUG	Metformin	500, 850 or 1000 mg depending on body weight once daily for 24 weeks

Timeline

• Start date: 2018-04-01
• Primary completion: 2019-10-01
• Completion: 2020-08-01
• First posted: 2018-04-06
• Last updated: 2019-04-18