To study the role of central insulin on glucose metabolism.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Endogenous glucose production.
Secondary outcome
Insulin concentration in de cerebrospinal fluid
glucoregulatory hormones
Background summary
Recent animal studies have shown that insulin signaling in the central nervous
sytem plays an important role in regulating the endogenous glucose (EGP)
production by the liver. This seems to be mediated via insulin receptors in the
hypothalamus. Activation of these receptors is needed for appropriate
inhibition of the EGP during hyperinsulinemia. This means that insulin
resistance of the hypothalamus might play a role in the pathophysiology of type
2 diabetes mellitus.
Study objective
To study the role of central insulin on glucose metabolism.
Study design
A randomised, cross-over study in 10 healthy men. They will be studied twice:
after administration of intransal insulin and administration of intranasal
sterile water. Endogenous glucose production will be measured using stable
isotopes. A lumbal drain will be placed for measurement of insulin
concentrations in the cerebrospinal fluid, after administration of intranasal
insulin.
Intervention
intranasal administration of insulin vs sterile water
Study burden and risks
Stable isotopes are not radioactive and are therefor harmless.
Previous studies have shown that intranasal insulin does not reach the systemic
circulation. Severe hypoglycaemia is therefore not expected. Moreover, glucose
measurements will be performed at 5 minutes intervals at the bedside.
We do not expect any complications during and after lumbar drain placement.
Risks of complications are minimized (see E7).
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Healthy men, ages between 18 and 35 years, BMI between 20 and 25 kg/m2, with a normal oral glucose tolerance test.
Exclusion criteria
* any medication or substance use
* diabetes mellitus II (DM II) in first degree family members
* smoking
* alcohol abuse ( >3/day)
* lipid disorders, renal insufficiency, elevated liver enzymes or TSH
* bleeding disorders
* prior surgery of the nose and/or septum
* allergic rhinitis
* known allergies to antibiotics, used as prophylaxis in this study
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2009-012899-26-NL |
| CCMO | NL28322.018.09 |