Metabolic Effects of Melatonin Treatment

• Status: Completed
• Trial end date: 2021-08-18
• Target enrollment: 0
• Participant gender: Male

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 indicating a central role of melatonin. Additionally, a certain single nucleotide polymorphism in the melatonin receptor gene, MTNR1B rs10830963, with an allele frequency of 30 %, is associated with increased fasting plasma glucose and T2DM. Due to treatment of, among other things, insomnia, the use of melatonin is increasing rapidly in Denmark with a 100-fold increase from 2007-2012 in children and adolescents. No previous studies have thoroughly assessed changes in glucose and fatty acid metabolism after 3 months of melatonin treatment in patients with T2DM.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Collaborator: University of Copenhagen
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• 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 Criteria:

• > 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