Glucose metabolism in familial hypobetalipoproteinemia
ISRCTN | ISRCTN35161775 |
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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
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 |
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r.blumer@amc.uva.nl |
Study information
Study design | Non-randomized controlled trial |
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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 |
Eligibility
Participant type(s) | Patient |
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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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Center (AMC), Department of Endocrinology and Metabolism (The Netherlands)
University/education
University/education
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
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 | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/08/2011 | Yes | No |