Targeting branched-chain amino acid oxidation to improve glycaemic control in patients with type 2 diabetes

Conditions

Type 2 diabetes

Brief summary

Glucose levels will be measured after an overnight fast expressed in mmol/l.

Detailed description

Glucose clearance in ml/kg determined during an OGTT at 6 weeks and glucose disposal rate (Rd) in mol/kg/min measured with the clamp at 12 weeks, O2-flux in pmol/mg/s measured with high resolution respirometry, insulin-stimulated change in respiratory exchange ratio (RER) with use of indirect calorimetry during the clamp, PCr/ATP-ratio determined with phosphorus magnetic resonance spectroscopy, Cardiac function will be measured in 2 ways: 1) ejection fraction (microL) with use of cine-MRI 2) diastolic cardiac function with use of ultrasound (transthoracic echocardiography) and will be assessed with the following parameters: • Left atrial maximum volume (ml) • Peak E-wave velocity (cm/sec) • Peak A-wave velocity (cm/sec) • Pulsed wave TDI e’velocity (cm/sec) at lateral and septal basal regions • Tricuspid regurgitation systolic jet velocity (m/sec), Cognitive function will be assessed in 2 ways: 1) Use of CANTAB 2) Questionnaires (Beck’s Depression Inventory and Pittsburgh Sleep Quality Index), Continuous glucose and ketone profile will be measure with use of the CGKM sensor

Related papers

No related papers found yet.

Interventions

DRUGPHEBURANE 483 mg/g granules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Glucose levels will be measured after an overnight fast expressed in mmol/l.	—

Secondary

Measure	Time frame
Glucose clearance in ml/kg determined during an OGTT at 6 weeks and glucose disposal rate (Rd) in mol/kg/min measured with the clamp at 12 weeks, O2-flux in pmol/mg/s measured with high resolution respirometry, insulin-stimulated change in respiratory exchange ratio (RER) with use of indirect calorimetry during the clamp, PCr/ATP-ratio determined with phosphorus magnetic resonance spectroscopy, Cardiac function will be measured in 2 ways: 1) ejection fraction (microL) with use of cine-MRI 2) diastolic cardiac function with use of ultrasound (transthoracic echocardiography) and will be assessed with the following parameters: • Left atrial maximum volume (ml) • Peak E-wave velocity (cm/sec) • Peak A-wave velocity (cm/sec) • Pulsed wave TDI e’velocity (cm/sec) at lateral and septal basal regions • Tricuspid regurgitation systolic jet velocity (m/sec), Cognitive function will be assessed in 2 ways: 1) Use of CANTAB 2) Questionnaires (Beck’s Depression Inventory and Pittsburgh Slee	—

Measure

Time frame

Glucose clearance in ml/kg determined during an OGTT at 6 weeks and glucose disposal rate (Rd) in mol/kg/min measured with the clamp at 12 weeks, O2-flux in pmol/mg/s measured with high resolution respirometry, insulin-stimulated change in respiratory exchange ratio (RER) with use of indirect calorimetry during the clamp, PCr/ATP-ratio determined with phosphorus magnetic resonance spectroscopy, Cardiac function will be measured in 2 ways: 1) ejection fraction (microL) with use of cine-MRI 2) diastolic cardiac function with use of ultrasound (transthoracic echocardiography) and will be assessed with the following parameters: • Left atrial maximum volume (ml) • Peak E-wave velocity (cm/sec) • Peak A-wave velocity (cm/sec) • Pulsed wave TDI e’velocity (cm/sec) at lateral and septal basal regions • Tricuspid regurgitation systolic jet velocity (m/sec), Cognitive function will be assessed in 2 ways: 1) Use of CANTAB 2) Questionnaires (Beck’s Depression Inventory and Pittsburgh Slee

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Countries

Netherlands

Outcome results

None listed