E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
physiological thyroid function in terms of thyroid iodide uptake and thyroid hormone production
knowledge can be extrapolated for treatment of thyroid diseases such as hyperthyroidism and thyroid carcinoma |
fysiologische schildklierfunctie in termen van schildklierjodiumopname en schildklierhormoon productie.
kennis kan geëxtrapoleerd worden ter verbetering van de behandeling van schildklieraandoeningen zoals hyperthyreoïdie en schildkliercarcinoom |
|
E.1.1.1 | Medical condition in easily understood language |
thyroid function |
schildklierfunctie |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
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 assess the physiological effects of metformin and hypocaloric dieting on thyroid iodide uptake and thyroid function in healthy volunteers. |
de veranderingen onderzoeken van het gebruik van metformine en het volgen van een hypocalorisch dieet op de schildklier jodium opname en schildklierfunctie in gezonde vrijwilligers. |
|
E.2.2 | Secondary objectives of the trial |
not applicable |
niet van toepassing |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
. male
. No mental illness
. lnformed consent
. Healthy, specifically no history of thyroid disease or renal insufficiency
. Aged between 18-50 years
. Normalweight (BMl: 18.5-25.0 kg/m2)
. Maintained stable body weight for previous 6 months |
- man
- geen psychische/psychiatrische aandoeningen.
- informed consent
- gezond
- leeftijd: 18-50 jaar
- normaalgewicht: BMI 18-25 kg/m2)
- stabiel gewicht afgelopen 6 maanden. |
|
E.4 | Principal exclusion criteria |
. Any thyroid condition: hypo- or hyperthyroidism, thyroid cancer, other thyroid conditions.
. Any chronic illness, including diabetes mellitus, acute or chronic infections, other disease requiring treatment.
. Use of any medication or homeopathic medications. Use of paracetamol is allowed.
. Smoking
. Previous radioactive iodide scanning or other imaging techniques with administration of iodide containing contrast fluids within 6 months.
. Use of supplements that contain large quantities of iodide
. Structural alcohol intake > 3 glasses/day
. Subjects who have taken part in any drug trial within 3 months prior start of this study. |
- mentale stoornissen (psychische/psychiatrische aandoeningen)
- schildklierproblematiek.
- chronische aandoeningen (diabetes mellitus, infecties, etc)
- gebruik van medicatie of homeopatische middelen (paracetamol toegestaan)
- roken
- in afgelopen 6 maanden radioactief jodium opname test of ondezoeken met jodium houdend contrast.
- structureel alcoholgebruik: >3 glazen/dagen
- binnen 3 maanden deelgenomen aan geneesmiddelenonderzoek. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
change in thyroid I-123 uptake before and after intervention |
verandering in schildklier I-123 opname voor en na interventie |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Participants will be advised to avoid certain products with high iodide content (mainlyseafood). Baseline measurements will be performed: thyroid I-123 uptake scanning and serum TSH, fT4 and T3.
then participants will be devided in 3 intervention groups for a twee week intervention:
- group 1 (7 participants): 2 week cours of metformin.
- group 2 (7 participants): 2 week course ofahypocaloric diet (40% caloric restriction)
- group 3 (3 participants): control group.
After intervention, again thyroid I-123 uptake measurements and serum TSH, fT4 and T3 will be performed. |
Alle deelnemers krijgen de instructie om een beperkt aantal producten die veel jodium bevatten, zoals zeewier en zeevis, te vermijden. Daarna worden baseline metingen verricht: bepaling van schildklier I-123 opname en serum TSH, fT4 en T3 worden bepaald. Vervolgens worden de deelnemers verdeeld over 3 groepen voor de interventie periode van 2 weken :
- groep 1 (7 deelnemers): 2 weken metformine slikken;
- groep 2 (7 deelnemers): 2 weken een laag calorisch dieet.
- groep 3 (3 deelnemers): controle groep.
na deze twee weken durende interventieperiode worden opnieuw metingen uitgevoerd: schildklier I-123 opname en serum TSH, fT4 en T3. |
|
E.5.2 | Secondary end point(s) |
change in serum TSH, fT4 and T3 before and after intervention |
verandering in serum TSH, fT4 en T3 na interventie. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline measurements will be performed: thyroid I-123 uptake scanning and serum TSH, fT4 and T3.
then participants will be devided in 3 intervention groups for a twee week intervention:
- group 1 (7 participants): 2 week cours of metformin.
- group 2 (7 participants): 2 week course of a hypocaloric diet (40% caloric restriction)
- group 3 (3 participants): 2 week ccontrol group.
After intervention, again thyroid I-123 uptake measurements and serum TSH, fT4 and T3 will be performed. |
Baseline metingen verricht: bepaling van schildklier I-123 opname en serum TSH, fT4 en T3 worden bepaald. Vervolgens worden de deelnemers verdeeld over 3 groepen voor de interventie periode van 2 weken :
- groep 1 (7 deelnemers): 2 weken metformine slikken ;
- groep 2 (7 deelnemers): 2 weken een laag calorisch dieet
- groep 3 (3 deelnemers): 2 weken controle groep.
na deze twee weken durende interventieperiode worden opnieuw metingen uitgevoerd: schildklier I-123 opname en serum TSH, fT4 en T3. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
physiological effect of metformin on thyroid iodide uptake and thyroid function |
fysiologische effect van metformine of schildklier jodium opname en schildklierfunctie |
|
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
hypocalorisch dieet |
hypocaloric diet |
|
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 | No |
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 | |