1. To evaluate whether patients with FCH have different pattern of hypothalamic neural activity compared to healthy control subjects, 2. To evaluate whether patients with FCH (index patients) have a different pattern of hypothalamic neural activity…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. differences in hypothalamic neural activity (and suppressive effect after
oral glucose load) between patients with FCH and healthy volunteers
Secondary outcome
mean change (in %) in beat-to-beat variation (lead III heart rhythm recording)
during study protocol
Background summary
Familial combined hyperlipidemia (FCH) is a frequently occurring disorder with
presence of dyslipidemia (elevated plasma triglyceride and cholesterol levels)
and premature atherosclerotic disease. Despite intensive research the last two
decades, the origin of FCH is still unresolved. Recent results from rodent
models suggest a dominant role of hypothalamic activity in the regulation of
triglyceride metabolism. In this background, we will evaluate whether
hypothalamic neural activity is different in patients with FCH compared with
healthy control subjects.
Study objective
1. To evaluate whether patients with FCH have different pattern of hypothalamic
neural activity compared to healthy control subjects,
2. To evaluate whether patients with FCH (index patients) have a different
pattern of hypothalamic neural activity compared to their gene-related
relatives that do not display FCH and a similar pattern of hypothalamic neural
activity with those who display FCH.
Study design
Randomized, single blind, case-control study. Patients with FCH (protocol A and
B), and matched healthy volunteers (protocol A), and gene-related relatives
(protocol B) will be scanned three times (protocol A) and two times (protocol
B) for analysis of hypothalamic neural activity by assessing change in blood
oxygen level-dependent (BOLD) contrast after ingestion of a glucose solution or
water using functional magnetic resonance imaging (fMRI).
Study burden and risks
Beside the investment of time and being fasting before subsequent visits
(depending on which protocol), no complications or risks are expected during
the procedures. The amount of glucose that will be drunk will give no-side
effects and is similar or less to that used in the conventional oral glucose
tolerance test.
Meibergdreef 9 (kamer F4.111)
1100 DD Amsterdam
Nederland
Meibergdreef 9 (kamer F4.111)
1100 DD Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Male patients (index patients in protocol B) with proven FCH (combined hyperlipidemia, premature atherosclerosis, positive family history for dyslipidemia and premature mortality (before age of 55 yrs))
Age 18-60 yr
Exclusion criteria
BMI > 25 kg/m2 or BMI < 19 kg/m2
Current or past history of alcohol intake > 2E/day
Smoking
Presence of active disease or past disease (that may affect variables measured in this protocol)
Irregular diet habits
Slimming or having a diet on medical indication
Medication (including those with central activity, e.g. antidepressants)
Claustrophobia
Diabetes or a family history positive for diabetes
Metal implants or metal objects that cannot be removed (e.g. piercings)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL22582.018.08 |