Hererditary effects of melatonin treatmen on glucose toleranse
Phase 1
- Conditions
- Impaired glucose tolerance in healthy study personsTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2011-005360-22-FI
- Lead Sponsor
- Vasa HVC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): glucose and insulin values in OGTT 30, 60,90, minutes;Timepoint(s) of evaluation of this end point: 3 months