Metabolic Effects of Melatonin Treatment

Plain-language summary

This study examines the metabolic effects of Melatonin treatment compared with placebo. It included men aged 40-70 with type 2 diabetes. It was conducted in Phase 1 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Completed

Sponsor

University of Aarhus

Intervention

Melatonin, Placebo Oral Tablet

Start date

9/26/2019

Estimated completion

8/18/2021

Countries

Denmark

Related genes

Locations

• Aarhus, Denmark

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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