Diabetes Clinical Trial
— MELAGOfficial title:
Does Melatonin Treatment Affect Glucose Tolerance Among Individuals With a Variant (rs10830963) of the Melatonin Receptor 1B (MTNR1B) Gene?
Verified date | January 2017 |
Source | Helsinki University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Finnish Medicines Agency |
Study type | Interventional |
The effect of 3 months of melatonin 4mg treatment on glucose tolerance in different variants
of the melatonin receptor 1B gene will be evaluated. The following will be done at 0 and 3
months:
- OGTT
- questionnaires about sleep and activity
- Actigraph
- Anthropometry
- Blood pressure
Status | Completed |
Enrollment | 45 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - signed informed concent - Known genotype for MTNR1B from the Botnia-ppp study - Age 18-75 years Exclusion Criteria: - Diabetes - Positive GAD-ab - Sever dysregulated hypertension - glaucoma - severe coronary heart disease or arrythmias - previous or ongoing severe ventricle or duodenal ulcer - psychosis or anxiety disorder - regular use of sleep pills, antidepressants or neuroleptics - creatinine > 130 µmol/L - elevated liver enzymes (ASAT, ALAT, ALP, GT, bilirubin) > 3 times reference value - inability to sign informed concent - other factor with according to the physician may affect treatment or results. - participation in other clinical study - allergy to melatonin or other substance in the capsule - hereditary galactose intolerance or glucose/galactose malabsorption - intention to become pregnant |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Finland | Botniacentret Jakobstad | Jakobstad | |
Finland | Vasa health care centre | Vasa |
Lead Sponsor | Collaborator |
---|---|
Helsinki University | Folkhalsan Research Center, Lund University |
Finland,
Tuomi T, Nagorny CL, Singh P, Bennet H, Yu Q, Alenkvist I, Isomaa B, Östman B, Söderström J, Pesonen AK, Martikainen S, Räikkönen K, Forsén T, Hakaste L, Almgren P, Storm P, Asplund O, Shcherbina L, Fex M, Fadista J, Tengholm A, Wierup N, Groop L, Mulder — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glucose tolerance | Glucose tolerance is measured in OGTT: 0,30,60,90 and 120 minute values of glucose and insulin. | 3 months | No |
Secondary | sleep | monitoring of sleep with questionnaires and activity monitoring | 3 months | No |
Secondary | Activity | Activity and sleep of the subjects is recorded with Actigraph at 0 and 3 months | 3 months | No |
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