ID
Bron
Aandoening
major depression; type 2 diabetes mellitus
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Depression symptoms (Inventory of Depressive Symptoms (IDS)); insulin sensitivity (hyperinsulinaemic euglycaemic clamp).
Onderzoeksopzet
Measures will be normally performed at three time points: just before the start of light therapy, after completion of four weeks of light therapy, and after four weeks follow-up. Several measures will be evaluated continuously during the intervention period.
Onderzoeksproduct en/of interventie
The intervention will consist of light therapy for four weeks 30 minutes every morning at home with bright white-yellowish light or dim green light.
Algemeen / deelnemers
M.A. Bremmer,
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4440196
ma.bremmer@vumc.nl
Wetenschappers
M.A. Bremmer,
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4440196
ma.bremmer@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
(1) male and female subjects 18 years or older; (2) having type 2 diabetes mellitus as judged by an expert panel based on HbA1c, diabetes medical history, use of glucose-lowering medication, and when deemed necessary additional tests (e.g. antibodies); and (3) having a major depressive episode according to DSM-IV criteria
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1) a recent history of, or current, light therapy; (2) shift worker; (3) a recent change in antidepressant or blood-glucose lowering medication or therapy (e.g. psychotherapy); (4) use of oral glucocorticoids, melatonin, or cytostatics; (5) pregnancy; (6) psychosis, mania, (probable) dementia, severe drug or alcohol abuse, delirium, and severe acute suicidality; (7) a history of light-induced migraine or epilepsy, or severe side effects to light therapy in the past; (8) visual acuity <60%, diabetic retinopathy EURODIAB grades 3, 4 or 5 (severe non-proliferative or preproliferative retinopathy, photocoagulated retinopathy, proliferative retinopathy), senile macula degeneration; (9) a(nother) medical condition or recent medical event that potentially compromises the effects or safety of light therapy
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL4802 |
NTR-old | NTR4942 |
CCMO | NL45295.029.13 |
OMON | NL-OMON44883 |