Overview

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