Condition category
Nutritional, Metabolic, Endocrine
Date applied
07/06/2006
Date assigned
07/06/2006
Last edited
10/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

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

Sponsor details

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

University/education

Website

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

  1. 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.

Additional files

Editorial Notes