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ISRCTN
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ISRCTN35161775
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ClinicalTrials.gov identifier
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Public title
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Glucose metabolism in familial hypobetalipoproteinemia
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Scientific title
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Acronym
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FHBL
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Serial number at source
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N/A
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Study hypothesis
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Patients with familial hypobetalipoproteinemia (FHBL) could have increased hepatic glucose production because of hepatic steatosis. In addition, peripheral insulin sensitivity could be enhanced since these patients have lower concentrations of intramyocellular lipids.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Non-randomized controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Familial hypobetalipoproteinemia (FHBL), hepatic steatosis
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Participants - inclusion criteria
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1. Male
2. Age >18 years of age
3. Body mass index (BMI) 20-35 kg/m^2
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Participants - exclusion criteria
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1. Known somatic illness
2. Use of medication influencing metabolism or blood clotting
3. Seropositive for hepatitis B surface antigen (HbsAg), hepatitis B surface antigen (HbcAg), hepatitis C virus (HCV), hepatitis A virus (HAV) or human immunodeficiency virus (HIV)
4. Having a metal device in the body
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Anticipated start date
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11/05/2006
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Anticipated end date
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01/10/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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22
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Interventions
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A hyperinsulinaemic clamp will be performed for 4.5 hours
using stabile isotopes (d2-glucose and D5-glycerol). In addition, muscle
biopsies will be taken and fat distribution will be studied by a dual energy x-ray absorptiometry (DEXA)-scan, a
computed tomography (CT)-scan and magnetic resonance spectroscopy (MRS). Patients with FHBL will be compared to healthy
controls matched for age,sex, BMI and waist circumference.
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Primary outcome measure(s)
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1. Insulin sensitivity at the level of glucose production by liver, glucose uptake by muscle and fat and lipolysis
2. Fat distribution by a DEXA, a CT-scan and MRS-spectroscopy
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Secondary outcome measure(s)
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1. Lipid levels
2. Glucoregulatory levels
3. (Adipo)cytokines
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Sources of funding
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Academic Medical Center (AMC), Department of Endocrinology and Metabolism
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Trial website
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Publications
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2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21547498
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Contact name
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Mr
R.
Blumer
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Address
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Academic Medical Center (AMC)
Department of Endocrinology and Metabolism
F5-162
P.O. Box 22660
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City/town
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Amsterdam
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Zip/Postcode
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1100 DD
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Country
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Netherlands
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Tel
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+31 (0)20 5669111
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Email
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r.blumer@amc.uva.nl
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Sponsor
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Academic Medical Center (AMC), Department of Endocrinology and Metabolism (The Netherlands)
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Address
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P.O. Box 22660
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City/town
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Amsterdam
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Zip/Postcode
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1100 DD
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Country
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Netherlands
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Date applied
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07/06/2006
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Last edited
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10/11/2011
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Date ISRCTN assigned
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07/06/2006
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