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Influence of lactate on the brain and lipid metabolism.


- candidate number8424
- NTR NumberNTR2522
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-sep-2010
- Secondary IDs09/010 METC
- Public TitleInfluence of lactate on the brain and lipid metabolism.
- Scientific TitleInfluence of lactate on the brain and triglyceride metabolism.
- ACRONYMlactate
- hypothesisLactate decreases TG-VLDL synthesis by the liver by decreased production. Since patients with FCH have a higher production, we hypothesize that they will have a significant decrease in their production.
- Healt Condition(s) or Problem(s) studiedFamilial combined hyperlipidemia
- Inclusion criteriaHealthy participants inclusion:
1. Male;
2. BMI < 26 kg/m2;
3. Age 18-65 yrs;
4. Normal HbA1c level;
5. Normal renal and liver function (creatinine < 150 umol/L, normal liver enzymes);
6. Not on any medication affecting glucose or lipid metabolism or affecting brain regulation (anti-depressants/anti-convulsants);
7. Alcohol intake less than 2 units per day;
8. No claustrophobia in the view of the MRS;
9. No foreign metal devices in the view of the MRS;
10. No panic disorder.

Inclusion criteria for people with FCH:
1. FCH patients meet the criteria of the nomogram of Veerkamp(37);
2. Inclusion criteria 3-9 are identical to healthy participants;
3. Males, matched with healthy participants for age;
4. BMI<27 kg/m2;
5. Triglyceride levels >2.5 mmol/l;
6. No relevant active disease;
7. No known cardiovascular disease;
8. No statins intake for at least 6 weeks.
- Exclusion criteriaMedication influencing the brain.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2010
- planned closingdate1-dec-2010
- Target number of participants20
- Interventions1. One day of venous lactate infusion and one day of saline infusion as a control, in healthy subjects and FCH patients;
2. MRS scan of the brain will be done before the start of the infusion and at the end of the infusion.
- Primary outcomeTG-VLDL synthesis by the liver measured by stable glycerol isotopes every hour. With the rate of disappearance curve synthesis will be calculated.
- Secondary outcomeMRS changes in brain to define lactate levels in the brain.
- Timepoints8 hours per intervention. There are two visits with one intervention with two weeks between them.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES B.M. Sondermeijer
- CONTACT for SCIENTIFIC QUERIESDr. Stroes
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryTG-VLDL synthesis by the liver will be studied during lactate vs saline infusion and in some patients MRS will be applied.
- Main changes (audit trail)
- RECORD7-sep-2010 - 3-okt-2010


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