Type 2 Diabetes Mellitus Clinical Trial
Official title:
Metabolic Effects of Melatonin Treatment
Verified date | August 2021 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | August 18, 2021 |
Est. primary completion date | May 3, 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years to 70 Years |
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Medical Research Laboratory | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of insulin sensitivity | Insulin sensitivity is assessed by a hyperinsulinemic euglycemic clamp, unit: mg/kg/min (mg of glucose to maintain euglycemia per kilogram of weight per minuts) | The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatment and compared afterwards with a paired T-tes | |
Primary | Change of insulin secretion change | Insulin secretion is assessed by an intravenous glucose tolerance test, unit: pmol/L (insulin) | The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatment | |
Primary | MTNR1a rs10830963 influence on change in insulin sensitivity and insulin secretion | MTNR1a rs10830963 genotype influence on insulin sensitivity and insulin secretion (see outcome 1 + 2) | The outcome will be measured after 3 months of placebo treatment and again after 3 months of melatonin treatment | |
Primary | Change of insulin signalling | Insulin signalling in muscle and adipose tissue assessed by western blot | The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatment | |
Secondary | Change of ambulatory blood pressure | Ambulatory blood pressure assessed with Mobil-O-graph, I.E.M., Stolberg, Germany (Unit: mmHg) | The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatment | |
Secondary | Change of arterial stiffness | Arterial stiffness assessed with Mobil-O-graph, I.E.M., Stolberg, Germany (unit: m/s) | The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatment | |
Secondary | Change of gut microbiome | Feces analysis of microbial mRNA | The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatment | |
Secondary | Change of sleep evaluation 1 | Pittsburg Sleep Quality Index Questionnaire (Points on a scale: range 0-57) | The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatment | |
Secondary | Change of sleep evaluation 2 | Epworth Sleepiness Scale Questionnaire (Points on a scale: range 0-24) | After 3 months treatmentThe outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatment | |
Secondary | Change of psychological health 1 | Major Depression Inventory Questionnaires (points on a scale: range 0-65) | The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatment | |
Secondary | Change of psychological health 2 | World Health Organization 5 Questionnaires (points on a scale: range 0-25) | The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatment | |
Secondary | Hormonal changes | Ghrelin, HbA1c, GLP-1, GLP-2, GIP, free fatty acids (FFA), leptin, cytokines, adiponectin, growth hormone, cortisol, hsCRP, CD163, MBL, IGF-1 and proinsulin measured by ELISA, RIA, or routine biochemical analysis. Unit: pmol/L | The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatment | |
Secondary | Change of glucose and palmitate kinetics | Tracer technique with infusion of radioactive labeled glucose and palmitate for determination of rate of appereance. Unit: mikromol/min | The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatment | |
Secondary | Change of regional glucose and palmitate uptake | Forearm model with arteriovenous differences of glucose and palmitate (Arterial glucose minus venous glucose = forearm uptake (unit mmol/l). The same applies for palmitate | The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatment | |
Secondary | Change of DEXA-scans | Evaluation of body composition and bone mineral density by DEXA-scan | The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatment | |
Secondary | Change of assessment of respiratory quotient (RQ) | Assessment of respiratory quotient (RQ) with indirect calorimetry (unit: VCO2/VO2) | The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatment | |
Secondary | Change of assessment of resting energy expenditure (REE) | Assessment of resting energy expenditure (REE) with indirect calorimetry (Unit J/s) | The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatment |
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