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NCT03917212 Clinical Trial

Energy Metabolism in Branched-chain Organic Acidemias

Metabolic Syndrome Clinical Trial

Official title:
Non-invasive Measurement of Energy Metabolism in Patients With Primary and Secondary Mitochondrial Diseases

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03917212
Other study ID # MITO-MRS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2012
Est. completion date March 2018

Study information
Verified date April 2019
Source German Diabetes Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Energy metabolism and insulin sensitivity were assessed in a case-control study in patients with branched-chain organic acidemias.

Description:

Children and adults with branched-chain organic acidemias and matched healthy humans underwent deep metabolic phenotyping using non-invasive magnetic resonance spectroscopy, oral glucose tolerance tests and measurements of leucocyte respirometry in order to assess changes in energy metabolism and insulin sensitivity.

Recruitment information / eligibility
Status Completed
Enrollment 57
Est. completion date March 2018
Est. primary completion date November 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years and older
Eligibility Inclusion Criteria:

- known branched-chain organic acidemia diagnosed by enzymatic or genetic test

- age>5 years

Exclusion Criteria:

- acute inflammatory conditions with fever, cold symptoms, gastro-intestinal infection within the last 24 hours

- contraindications for an oral glucose tolerance test such as fasting blood glucose >126 mg/dl, severe chronic gastrointestinal conditions, allergy against black currant

- contraindications for magnetic resonance tomography (MRT) such as claustrophobia, metallic implants which are not MRT compatible

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
No intervention, observational study with metabolic characterisation

Locations
Country Name City State
Germany Department of General Pediatrics, Neonatology and Pediatric Cardiology of the University Children's Hospital Düsseldorf Düsseldorf NRW
Germany Institute for Clinical Diabetology, German Diabetes Center Düsseldorf NRW

Sponsors (2)
Lead Sponsor Collaborator
German Diabetes Center University Children’s Hospital, Düsseldorf

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hepatic and skeletal muscle energy metabolism Hepatic and skeletal muscle energy metabolism assessed by magnetic resonance spectroscopy At baseline
Secondary Insulin sensitivity Insulin sensitivity measured from oral glucose tolerance test At baseline
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