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ID
Source
Brief title
Health condition
Diabetes Mellitus type II (DM II)
glucose metabolism/glucose metabolisme
Sponsors and support
Intervention
Outcome measures
Primary outcome
Endogenous glocose production.
Secondary outcome
Insulin concentration in the CSF.
Background summary
Insulin is mainly known for its peripheral effects on the metabolism of glucose, fat and protein. The role of insulin signaling in the brain is only incompletely understood. To best way to study the effects of insulin in the brain, with low levels of insulin in the systemic circulations, is by administering it intranasally.
10 healthy male subjects will be studied twice, after administration of intranasal insulin and placebo. Glucose metabolism will be measured in the basal state and after administration of insulin/placebo, using stable isotopes. An intraspinal catheter will be inserted during the insulin study-day to measure the concentration of insulin in the CSF.
Study objective
We hypothesize that administration of intranasal insulin:
1. Inhibits endogenous glucose production, indepently of systemic insulin;
2. Increases the insulin concentration in the cerebrospinal fluid (CSF).
Study design
Every 10 - 30 minutes after intranasal insulin/placebo.
Intervention
Each subject will be studied twice. Intranasal insulin and placebo will be administered. Glucose metabolism will be measured using stable isotopes. An intraspinal catheter will be inserted during the insulin-study day to measure the concentration of insulin in the CSF.
Department of Endocrinology & Metabolism<br>
F5-162
N.M. Lammers
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5662663
N.M.Lammers@amc.uva.nl
Department of Endocrinology & Metabolism<br>
F5-162
N.M. Lammers
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5662663
N.M.Lammers@amc.uva.nl
Inclusion criteria
1. Lean healthy male volunteers;
2. Age 18-35 years;
3. BMI 20-25 kg/m2;
4. Normal oral glucose intolerance test according to the ADA-criteria.
Exclusion criteria
1. Any medication or substance use;
2. DM II;
3. Smoking;
4. Alcohol abuse (>3/day);
5. Lipid disorders, renal insufficiency, elevated liver enzymes or TSH;
6. Bleeding disorders;
7. Prior surgery of the nose and/or septum;
8. Allergic rhinitis;
9. Known allergies to antibiotics, used as prophylaxis in this study.
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL1884 |
| NTR-old | NTR1998 |
| Other | METC Academic medical center : MEC 09/121 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |