Glucose metabolism in familial hypobetalipoproteinemia
| ISRCTN | ISRCTN35161775 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35161775 |
| Protocol serial number | N/A |
| Sponsor | Academic Medical Center (AMC), Department of Endocrinology and Metabolism (The Netherlands) |
| Funder | Academic Medical Center (AMC), Department of Endocrinology and Metabolism |
- 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 |
|---|---|
| r.blumer@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomized controlled trial |
| Secondary study design | Non randomised controlled trial |
| 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(s) |
1. Insulin sensitivity at the level of glucose production by liver, glucose uptake by muscle and fat and lipolysis |
| Key secondary outcome measure(s) |
1. Lipid levels |
| Completion date | 01/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
