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Completed

NCT Number: NCT03917212

Energy Metabolism in Branched-chain Organic Acidemias

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

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Key information

Conditions

Energy Metabolism Digestive System Diseases Dyslipidemias Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Lipid Metabolism Disorders Liver Diseases Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of General Pediatrics, Neonatology and Pediatric Cardiology of the University Children's Hospital Düsseldorf, Düsseldorf, North Rhine-Westphalia, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention, observational study with metabolic characterisation

Primary outcomes

  1. Hepatic and skeletal muscle energy metabolism

    Time frame: At baseline

    Hepatic and skeletal muscle energy metabolism assessed by magnetic resonance spectroscopy

Secondary outcomes

  1. Insulin sensitivity

    Time frame: At baseline

    Insulin sensitivity measured from oral glucose tolerance test

Sponsors and collaborators

Lead sponsor

German Diabetes Center

Other

Collaborators

  • University Children's Hospital, Düsseldorf

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Apr 16, 2019
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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