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Glucose metabolism in Familial Hypobetalipoproteinemia.


- candidate number2059
- NTR NumberNTR665
- ISRCTNISRCTN35161775
- Date ISRCTN created7-jun-2006
- date ISRCTN requested16-mei-2006
- Date Registered NTR18-apr-2006
- Secondary IDsN/A 
- Public TitleGlucose metabolism in Familial Hypobetalipoproteinemia.
- Scientific TitleGlucose metabolism in Familial Hypobetalipoproteinemia.
- ACRONYMFHBL study
- hypothesisPatients with Familial Hypobetalipoproteinemia (FHBL) could have increased hepatic glucose production because of hepatic steatosis. Additionally, peripheral insulin sensitivity could be enhanced since these patients have lower concentrations of intramyocellular lipids.
- Healt Condition(s) or Problem(s) studiedFamilial Hypobetalipoproteinemia (FHBL), Hepatic steatosis
- Inclusion criteria1. Male;
2. Age > 18 y;
3. BMI 20-35 kg/m2.
- Exclusion criteria1. Known somatic illness;
2. Use of medication influencing metabolism/ blood clotting;
3. Seropositive for HbsAg, HbcAg, HCV, HAV or HIV;
4. Having metal device in the body.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 11-mei-2006
- planned closingdate1-okt-2006
- Target number of participants22
- InterventionsA hyperinsulinaemic clamp will be performed for 4 hours using stabile isotopes (d2-glucose and D5-glycerol). Additionally, muscle biopsies will be taken and fat distribution will be studied by a DEXA-, a CT-scan and MRS-spectroscopy. Patients with FHBL will be compared to healthy controls matched for age,sex, BMI and waist circumference.
- Primary outcome1. Insulin sensitivity at the level of glucose production by liver, glucose uptake by muscle+fat and lipolysis;
2. Fat distribution by a DEXA-, a CT-scan and MRS-spectroscopy.
- Secondary outcome1. Lipid levels;
2. Glucoregulatory levels;
3. (Adipo)cytokines.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES R. Blumer
- CONTACT for SCIENTIFIC QUERIESProf. Dr. H.P. Sauerwein
- Sponsor/Initiator Academic Medical Center (AMC), Department of Endocrinology and Metabolism
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Endocrinology and Metabolism
- PublicationsN/A
- Brief summaryThis study investigates insulin sensitivity at central and peripheral level in patients with familial hypobetalipoproteinemia and compares it to healthy controls. Body fat distribution will be studied as well.
- Main changes (audit trail)
- RECORD18-apr-2006 - 9-sep-2009


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