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The effects of intranasal insulin on glucose metabolism in healthy men.


- candidate number6436
- NTR NumberNTR1998
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-sep-2009
- Secondary IDsMEC 09/121 METC Academic medical center
- Public TitleThe effects of intranasal insulin on glucose metabolism in healthy men.
- Scientific TitleThe effects of intranasal insulin on glucose metabolism in healthy men.
- ACRONYMN/A
- hypothesisWe 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).
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Glucose metabolism
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 10-jan-2009
- planned closingdate6-jan-2010
- Target number of participants10
- InterventionsEach 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.
- Primary outcomeEndogenous glocose production.
- Secondary outcomeInsulin concentration in the CSF.
- TimepointsEvery 10 - 30 minutes after intranasal insulin/placebo.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES N.M. Lammers
- CONTACT for SCIENTIFIC QUERIES M.J.M. Serlie
- Sponsor/Initiator Academic Medical Center (AMC), Department of Endocrinology and Metabolism
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Endocrinology and Metabolism
- PublicationsN/A
- Brief summaryInsulin 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.
- Main changes (audit trail)
- RECORD9-sep-2009 - 12-okt-2009


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