Glucose metabolism in familial hypobetalipoproteinemia

ISRCTN	ISRCTN35161775
DOI	https://doi.org/10.1186/ISRCTN35161775
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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 design	Non-randomized controlled trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	FHBL
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	11/05/2006
Completion date	01/10/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target number of participants	22
Key inclusion criteria	1. Male 2. Age >18 years of age 3. Body mass index (BMI) 20-35 kg/m^2
Key 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
Date of first enrolment	11/05/2006
Date of final enrolment	01/10/2006

Academic Medical Center (AMC)

Amsterdam
1100 DD
Netherlands

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

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

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

University/education

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

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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