Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-25 @ 2:35 AM
NCT ID:
NCT03859934
Eligibility 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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT03859934
Study Brief:
Protocol Section:
NCT03859934