To boost amino acid oxidation in diabetes
- Conditions
- type 2 diabetessodium phenyl butyrateinsulin resistancebranched-chain amino acidsmitochondrial functionenergy metabolism
- Registration Number
- NL-OMON28825
- Lead Sponsor
- Maastricht UniversityNUTRIMUniversiteitssingel 406229 ER Maastricht+31 43 3881476secretariaat-nutrim@maastrichtuniversity.nl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
1.Patients are able to provide signed and dated written informed consent prior to any study specific procedures
2.Women are post-menopausal (defined as at least 1 year post cessation of menses) and aged =45 and =75 years. Males are aged =40 years and =75 years
3.Patients should have suitable veins for cannulation or repeated venipuncture
4.Caucasians
5.BMI: 25-38 kg/m2
6.Diagnosed with T2D at least 1.5 years before the start of the study
1.Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator
2.Participate in physical activity more than 3 times a week
3.Unstable body weight (weight gain or loss > 5 kg in the last three months)
4.Insulin dependent T2D
5.Patients with congestive heart failure and and/or severe renal and or liver insufficiency or known sodium retention with oedema
6.Patients using Probalan (probenecid), Haldol (haloperidol), Depakene (valproate) or medical products containing corticosteroids
7.Men: Hb <8.4 mmol/L, Women: Hb <7.8 mmol/l
8. Any contra-indication MRI scanning. These contra-indications include patients with e.g. the following:
• Central nervous system aneurysm clip
• Implanted neural stimulator
• Implanted cardiac pacemaker of defibrillator
• Cochlear implant
• Metal containing corpora aliena in the eye or brains
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary objective is the delta change in whole body insulin sensitivity expressed as glucose disposal rate (µmol/kg/min) upon 2 weeks of Na-PB vs. placebo treatment.
- Secondary Outcome Measures
Name Time Method •muscle mitochondrial function upon 2 days and 2 weeks treatment periods expressed as O2-flux in pmol/mg/s<br>•whole-body energy metabolism upon 2 days and 2 weeks treatment periods expressed as respiratory exchange ratio (RER) and kJ/kg/min<br>•fat accumulation in muscle and the liver expressed as % upon 2 days and 2 weeks treatment periods<br>