No registrations found.
ID
Source
Health condition
mitochondrial myopathy
Sponsors and support
Erasmus Medical Center
Maxima Medical Center
Univerisity Medical Centre Maastricht
University Medical Center Groningen
Intervention
Outcome measures
Primary outcome
1. Steady state oxygen consumption at 50%Wmax;
2. In vivo mitochondrial function (31P MRS);
3. In vitro mitochondrial function (state 3, 4, U respiration).
Secondary outcome
1. mtDNA copy number;
2. C1, C2, C3, C4, F1F0ATPase, ANT content;
3. Muscle fiber type composition.
Background summary
The objective of the study is to test if supplementation of dietary inorganic nitrate (8.5 mg/kg body wt/day) to normal diet improves exercise performance in patients with mitochondrial myopathy. The main study parameters to asses the effect of nitrate intake will be: (i) steady state oxygen consumption at 50%Wmax, (ii)
in vivo mitochondrial function (31P MRS), (iii)
in vitro mitochondrial function (state 3, 4, U respiration).
Study objective
Dietary inorganic nitrate supplementation will decrease O2 cost of exercise in patients with mitochondrial myopathy.
Study design
Day 1 and day 8.
Intervention
8 days dietary inorganic nitrate supplementation (sodium nitrate 8.5mg/kg body wt/day dissolved in 250 ml water).
P.O. box 513
J.P.J. Schmitz
Eindhoven 5600 MB
The Netherlands
+31 (0)40 2472449
J.P.J.Schmitz@tue.nl
P.O. box 513
J.P.J. Schmitz
Eindhoven 5600 MB
The Netherlands
+31 (0)40 2472449
J.P.J.Schmitz@tue.nl
Inclusion criteria
1. Diagnosis mitochondrial myopathy;
2. Age 18+.
Exclusion criteria
1. Pacemaker / ICS or other contra indication for MRI;
2. Claustrophobia;
3. Use of beta blocker therapy;
4. Use of oral anti-coagulants;
5. Use of aspirine NSAID's;
6. Use of calcium antagonists;
7. Use of inorganic nitrate;
8. Cardio-vascular disease;
9. Cerebro-vascular complications;
10. Neurological diseases of deficits;
11. Vascular complications.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3177 |
| NTR-old | NTR3321 |
| CCMO | NL36927.015.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON39110 |