Hererditary effects of melatonin treatmen on glucose toleranse

Does melatonin (CircadinR) worsen glucose tolerance in individuals with at (rs10830963) variant in the melatonin receptor 1B (MTNR1B) gene?

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005360-22-FI

Enrollment

Registered

2012-02-01

Start date

2012-06-29

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impaired glucose tolerance in healthy study persons

Interventions

Trade Name: Circadin Product Name: Circadin Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: known genotype for MTNR1B, age 18-75 years, health individual Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Diabetes, positive GAD antibodies, severe hypertension, glaukoma, coronary heart disease or arrhytmia, ventricle or duodenal ulcer, psychosis or severe psychiatric disase, severe sleep disorder, use of alpha or betaadrenerg blockers, creatinine >130, liver enzymes (ASAT, ALAT, ALP, GT, bilirubin) > 3 times normal, participation in another study, allergy to melatonin or capsules used

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the effect of melatonin on glucose tolerance in subjects with a variant (rs10830963) in the melatonin receptor 1B (MTNR1B)? ;Secondary Objective: Sleep quality;Primary end point(s): glucose tolerance i OGTT 120 minutes;Timepoint(s) of evaluation of this end point: 3 months	—

Secondary

Measure	Time frame
Secondary end point(s): glucose and insulin values in OGTT 30, 60,90, minutes;Timepoint(s) of evaluation of this end point: 3 months	—

Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026