Raclopride-PET/MRT
Atslēgvārdi
Abstrakts
Datumi
| Pēdējoreiz pārbaudīts: | 04/30/2020 |
| Pirmais iesniegtais: | 08/02/2018 |
| Paredzētā reģistrācija iesniegta: | 08/15/2018 |
| Pirmais izlikts: | 08/16/2018 |
| Pēdējais atjauninājums iesniegts: | 07/23/2020 |
| Pēdējā atjaunināšana ievietota: | 07/26/2020 |
| Faktiskais studiju sākuma datums: | 02/19/2017 |
| Paredzamais primārās pabeigšanas datums: | 06/29/2022 |
| Paredzamais pētījuma pabeigšanas datums: | 12/30/2022 |
Stāvoklis vai slimība
Iejaukšanās / ārstēšana
Other: Intranasal insulin
Other: Placebo
Fāze
Roku grupas
| Roka | Iejaukšanās / ārstēšana |
|---|---|
| Placebo Comparator: Placebo Intranasal placebo administration | Other: Placebo placebo intranasal administration |
| Active Comparator: Intranasal insulin Intranasal insulin administration | Other: Intranasal insulin intranasal administration of insulin (160 IU) |
Atbilstības kritēriji
| Vecums, kas piemērots studijām | 20 Years Uz 20 Years |
| Dzimumi, kas ir piemēroti studijām | Male |
| Pieņem veselīgus brīvprātīgos | Jā |
| Kritēriji | Inclusion Criteria: - Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures. - Intake of any medication - HbA1C <6% - BMI 20-25 kg/m² - Clinical routine blood parameters within the normal ranges - All participants must agree to get informed of unexpected detected, clinical relevant findings. Exclusion Criteria: - Acute diseases such as infections (e.g.) - Any relevant cardiovascular disease - Any surgery within the last three months - Any neurologic or psychiatric disease - Known allergies - Hb < 13 g/dl - Presence of any contraindication for the conduct of an MRI investigation, such as cardiac pacemakers, ferromagnetic haemostatic clips in the central nervous system, metallic splinters in the eye, ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators, cochlear implants, insulin pumps and nerve stimulators, prosthetic heart valves etc. - Claustrophobia |
Rezultāts
Primārie rezultāti
1. Effects of nasal insulin vs. placebo on the insulin sensitivity of the human brain as well as effects on regional availability of dopamine receptors. [0-60 min]
Sekundārie iznākuma mērījumi
1. Differences between normalweight and overweight subjects regarding insulin sensitivity and availability of dopamine receptors [0 - 60 min]
2. Effects of nasal insulin vs. placebo on changes in plasma insulin levels [0 - 60min]
3. Effects of nasal insulin vs. placebo on changes in plasma glucose levels [0 - 60min]
4. Effects of nasal insulin vs. placebo on changes in FFA levels [0 - 60min]
5. Effects of nasal insulin vs. placebo on changes in prolactin levels as a proxy for the dopaminergic tonus [0 - 60min]
6. Effects of nasal insulin vs. placebo on changes in autonomic nervous system [-30 - 60 min]
