Metformin in Children With Fragile X Syndrome

• Status: Not yet recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This study is a controlled trial of metformin in children with fragile X syndrome(FXS). The age of FXS children range from 2 to 16 years old. Participants will be randomized in a double-blind design to either drug or placebo for 6-month period. The primary objectives are to assess metformin in treatment of behavior problems, cognitive and language with fragile X syndrome.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Fudan University
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Genetic testing confirms the diagnosis of FXS

• Participate in the study with the informed consent of the guardian

• BMI>the 3rd percentile

• Not taking more than 2 therapeutic drugs

• Able to receive regular follow-up visits

Exclusion Criteria:

• Malnutrition

• Primary heart disease

• Severe infection or acute clinical illness

• Gastrointestinal, renal, or hepatic disease

• Previous history of lactic acidosis

• previous use of metformin intolerant

• Use of angiotensin converting enzyme inhibitors, use of anticoagulants, vitamin B12 deficiency, alcohol consumption

• Unstable systemic diseases other than FXS

• Changes in clinical medication