Contact information
Type
Scientific
Primary contact
Mr R. Blumer
ORCID ID
Contact details
Academic Medical Center (AMC)
Department of Endocrinology and Metabolism
F5-162
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5669111
r.blumer@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
FHBL
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Non-randomized controlled trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Familial hypobetalipoproteinemia (FHBL), hepatic steatosis
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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
Secondary outcome measures
1. Lipid levels
2. Glucoregulatory levels
3. (Adipo)cytokines
Overall trial start date
11/05/2006
Overall trial end date
01/10/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male
2. Age >18 years of age
3. Body mass index (BMI) 20-35 kg/m^2
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
22
Participant exclusion criteria
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
Recruitment start date
11/05/2006
Recruitment end date
01/10/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
Funders
Funder type
University/education
Funder name
Academic Medical Center (AMC), Department of Endocrinology and Metabolism
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21547498
Publication citations
-
Results
Visser ME, Lammers NM, Nederveen AJ, van der Graaf M, Heerschap A, Ackermans MT, Sauerwein HP, Stroes ES, Serlie MJ, Hepatic steatosis does not cause insulin resistance in people with familial hypobetalipoproteinaemia., Diabetologia, 2011, 54, 8, 2113-2121, doi: 10.1007/s00125-011-2157-x.