E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy subjects |
Gezonde proefpersonen |
|
E.1.1.1 | Medical condition in easily understood language |
Healthy subjects |
Gezonde proefpersonen |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To study the effect of bile acids on brown adipose tissue activity and energy expenditure in humans. |
Het effect van galzuren op bruin vet activiteit en energiegebruik bij mensen bestuderen. |
|
E.2.2 | Secondary objectives of the trial |
The effect of bile acids on - skin temperature - body core temperature - skin perfusion - mitochondrial respiration in skeletal muscle - browning of white adipocytes |
Het effect van galzuren op - huidtemperatuur - kerntemperatuur - huiddoorbloeding - mitochondriele respiratie in skeletspier - 'browning' van wit vet |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Caucasians - Age: 18-30 years - Gender: male and female (females only on a specific oral contraceptive pill; microgynon 30 or levonorgestrel/ethinylestradiol) - BMI: 18-25 kg/m2 - Good general health |
- Caucasiers - Leeftijd 18 -30 jaar - Geslacht: mannen en vrouwen (vrouwen alleen als zij een specifieke orale anticonceptiepil gebruiken; microgynon 30 of levonorgestrel/ethinylestradiol) - BMI: 18-28 kg/m2 - Goede algemene gezondheid |
|
E.4 | Principal exclusion criteria |
- Psychologically unstable subjects (as judged by the treating medical specialist) - Subjects with mental retardation (as judged by the treating medical specialist) - Subjects with severe behavior disorders (as judged by the treating medical specialist) - Pregnancy or lactation - The use of the following medication one month before the study is an exclusion criterium; ß-blockers, ursodeoxycholic acid, bile acid sequestrants, antacids - Participation in an intensive weight-loss program or vigorous exercise program during the last year before the start of the study - Abuse of drugs and/or alcohol - Severe diabetes which requires application of insulin or patients with diabetes-related complications - Surgery of the gastro-intestinal tract (only appendectomy is allowed) - Previous ERCP with papillotomy - History of cholesystectomy or disease of the gallbladder, biliary system and/or liver - Hyperthyroidism or hypothyroidism - BMI > 25 kg/m2 - Participation in earlier research or medical examinations that included PET/CT scanning |
- Psychologisch instabiele personen (zoals beoordeeld door de behandelend arts) - Personen met mentale retardatie (zoals beoordeeld door de behandelend arts) - Personen met ernstige gedragsstoornissen(zoals beoordeeld door de behandelend arts) - Zwangeren vrouwen of vrouwen die borstvoeding geven - Gebruik van een middel uit een van de volgende medicijngroepen; beta-blokkers, ursodeoxycholzuur, galzuurbinders, antacida - Deelname aan een intensief programma gericht op gewichtsverlies of drastische sportprogramma in het jaar voorafgaand aan de studie - Overmatig gebruik van alcohol en/of drugs - Ernstige diabetes, waarvoor insuline-gebruik noodzakelijk is of aan diabetes gerelateerde complicaties - Operatie aan het gastro-intestinale stelsel (alleen appendectomie is toegestaan) - ERCP met papillectomie in de voorgeschiedenis - Cholecystectomie, ziekten aan galblaas, galwegen en/of lever in de voorgeschiedenis - Hyperthyreoidie of hypothyreoidie - BMI > 25 kg/m2 - Deelname aan een eerdere studie/medisch onderzoek met PET/CT scan |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Brown adipose tissue activity - Energy expenditure |
- Bruin vet activiteit - Energiegebruik |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Directly after the measurements |
Direct na de metingen |
|
E.5.2 | Secondary end point(s) |
- skin temeprature - body core temperature - skin perfusion - mitochondrial respiration in myocytes - ' browning' of white fat |
- huidtemperatuur - kerntemperatuur - huiddoorbloeding - mitochondriele respiratie in skeletspier - ' browning' van wit vet |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Directly after measurements |
Direct na de metingen |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Koude-expositie |
Cold-exposure |
|
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |