Glucose metabolism in familial hypobetalipoproteinemia

ISRCTN ISRCTN35161775
DOI https://doi.org/10.1186/ISRCTN35161775
Secondary identifying numbers N/A
Submission date
07/06/2006
Registration date
07/06/2006
Last edited
10/11/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr R. Blumer
Scientific

Academic Medical Center (AMC)
Department of Endocrinology and Metabolism
F5-162
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone +31 (0)20 5669111
Email r.blumer@amc.uva.nl

Study information

Study designNon-randomized controlled trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymFHBL
Study objectivesPatients 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedFamilial hypobetalipoproteinemia (FHBL), hepatic steatosis
InterventionA 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 typeOther
Primary outcome measure1. 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 measures1. Lipid levels
2. Glucoregulatory levels
3. (Adipo)cytokines
Overall study start date11/05/2006
Completion date01/10/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexMale
Target number of participants22
Key inclusion criteria1. Male
2. Age >18 years of age
3. Body mass index (BMI) 20-35 kg/m^2
Key exclusion criteria1. 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
Date of first enrolment11/05/2006
Date of final enrolment01/10/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Center (AMC), Department of Endocrinology and Metabolism (The Netherlands)
University/education

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

University/education

Academic Medical Center (AMC), Department of Endocrinology and Metabolism

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2011 Yes No