Status:
COMPLETED
Metabolic Effects of Melatonin Treatment
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
University of Copenhagen
Conditions:
Metabolic Disease
Insulin Sensitivity
Eligibility:
MALE
40-70 years
Phase:
PHASE1
Brief Summary
Modern living is associated with an epidemic of type 2 diabetes mellitus (T2DM). Sleep disturbances such as insomnia or frequent awakenings are strong risk factors for T2DM with several studies indica...
Detailed Description
Modern living is associated with an epidemic of type 2 diabetes mellitus (T2DM). Sleep disturbances such as insomnia or frequent awakenings are strong risk factors for T2DM with several studies indica...
Eligibility Criteria
Inclusion
- Male sex
- Caucasian race
- Type 2 Diabetes Mellitus (T2DM)
- T2DM duration of maximum 20 years
- Age 40-70 years
- BMI between 25-35 kg/m2 at T2DM debut
- Written consent prior to study participation
Exclusion
- \> 3 daily antihypertensive drugs
- Blood pressure \> 160/100 mmHg
- Insulin treatment
- \> 3 daily oral antidiabetic drugs
- \> 1 lipid lowering drug
- HbA1c \> 65
- Heart failure (New York Heart Association Class III or IV), liver disease (alanine aminotransferase (ALAT) \> twice the upper limit of normal serum concentration), plasma creatinine \> 130 µmol/L and/or albuminuria, goiter, active cancer, acute or chronic pancreatitis
- Treatment with antidiabetic medicine that cannot be paused on study days (or for a week if the participants is treated with longtime-acting GLP-1 analogs)
- Shift work within the last year
- Travel across \>4 time zones planned within the next 6 months
- Use of melatonin on a regular basis within the last year
- Severe illness
- \> 14 units of alcohol/week
- Previous diagnosis of a sleep disorder
- Present or earlier alcohol or drug abuse
- Unable to give informed consent
- Allergy towards melatonin
- Daily consumption of benzodiazepines, fluvoxamine, amiodarone, efavirenz, fluoroquinolones, rifampicin, and carbamazepine due to interactions with the pharmacokinetics of melatonin.
- Severe sleep apnea (\>30 respiration breaks/hour over 10 seconds)
- Medical treated depression or anxiety disorders within the last 3 years
- Daily consumption of selective serotonin reuptake inhibitors or tricyclic antidepressants
Key Trial Info
Start Date :
September 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2021
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03859934
Start Date
September 26 2019
End Date
August 18 2021
Last Update
August 25 2021
Active Locations (1)
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1
Medical Research Laboratory
Aarhus, Denmark, 8200