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Report for SNP rs10830963
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There are 2 clinical trials
Clinical Trials
1 Does Melatonin Treatment Affect Glucose Tolerance Among Individuals With a Variant (rs10830963) of the Melatonin Receptor 1B (MTNR1B) Gene?
The effect of 3 months of melatonin 4mg treatment on glucose tolerance in different variants of the melatonin receptor 1B gene will be evaluated. The following will be done at 0 and 3 months: - OGTT - questionnaires about sleep and activity - Actigraph - Anthropometry - Blood pressure
NCT01705639 Diabetes Glucose Tolerance Drug: Melatonin
Does Melatonin Treatment Affect Glucose Tolerance Among Individuals With a Variant (rs10830963) of the Melatonin Receptor 1B (MTNR1B) Gene?. Melatonin and Glucose Tolerance Among Individuals With a Variant of the MTNR1B Gene The effect of 3 months of melatonin 4mg treatment on glucose tolerance in different variants of the melatonin receptor 1B gene will be evaluated.
Primary Outcomes
Description: Glucose tolerance is measured in OGTT: 0,30,60,90 and 120 minute values of glucose and insulin.
Measure: Glucose tolerance Time: 3 monthsSecondary Outcomes
Description: monitoring of sleep with questionnaires and activity monitoring
Measure: sleep Time: 3 monthsDescription: Activity and sleep of the subjects is recorded with Actigraph at 0 and 3 months
Measure: Activity Time: 3 months2 Metabolic Effects of Melatonin Treatment
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.
NCT03859934 Metabolic Disease Insulin Sensitivity Glucose Metabolism Disorders (Including Diabetes Mellitus) Type 2 Diabetes Mellitus Blood Pressure Inflammation Drug: Melatonin Drug: Placebo Oral Tablet MeSH:Diabetes Mellitus Insulin Resistance Metabolic Diseases Glucose Metabolism Disorders Inflammation
HPO:Diabetes mellitus Insulin resistance
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.
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).
3. Does the MTNR1B rs10830963 risk allele alter the insulin secretion and insulin sensitivity compared with carries of the normal variant after chronic melatonin treatment?
Primary Outcomes
Description: 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)
Measure: Change of insulin sensitivity Time: 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-tesDescription: Insulin secretion is assessed by an intravenous glucose tolerance test, unit: pmol/L (insulin)
Measure: Change of insulin secretion change Time: The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatmentDescription: MTNR1a rs10830963 genotype influence on insulin sensitivity and insulin secretion (see outcome 1 + 2)
Measure: MTNR1a rs10830963 influence on change in insulin sensitivity and insulin secretion Time: The outcome will be measured after 3 months of placebo treatment and again after 3 months of melatonin treatmentDescription: Insulin signalling in muscle and adipose tissue assessed by western blot
Measure: Change of insulin signalling Time: The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatmentSecondary Outcomes
Description: Ambulatory blood pressure assessed with Mobil-O-graph, I.E.M., Stolberg, Germany (Unit: mmHg)
Measure: Change of ambulatory blood pressure Time: The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatmentDescription: Arterial stiffness assessed with Mobil-O-graph, I.E.M., Stolberg, Germany (unit: m/s)
Measure: Change of arterial stiffness Time: The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatmentDescription: Feces analysis of microbial mRNA
Measure: Change of gut microbiome Time: The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatmentDescription: Pittsburg Sleep Quality Index Questionnaire (Points on a scale: range 0-57)
Measure: Change of sleep evaluation 1 Time: The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatmentDescription: Epworth Sleepiness Scale Questionnaire (Points on a scale: range 0-24)
Measure: Change of sleep evaluation 2 Time: After 3 months treatmentThe outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatmentDescription: Major Depression Inventory Questionnaires (points on a scale: range 0-65)
Measure: Change of psychological health 1 Time: The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatmentDescription: World Health Organization 5 Questionnaires (points on a scale: range 0-25)
Measure: Change of psychological health 2 Time: The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatmentDescription: 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
Measure: Hormonal changes Time: The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatmentDescription: Tracer technique with infusion of radioactive labeled glucose and palmitate for determination of rate of appereance. Unit: mikromol/min
Measure: Change of glucose and palmitate kinetics Time: The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatmentDescription: Forearm model with arteriovenous differences of glucose and palmitate (Arterial glucose minus venous glucose = forearm uptake (unit mmol/l). The same applies for palmitate
Measure: Change of regional glucose and palmitate uptake Time: The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatmentDescription: Evaluation of body composition and bone mineral density by DEXA-scan
Measure: Change of DEXA-scans Time: The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatmentDescription: Assessment of respiratory quotient (RQ) with indirect calorimetry (unit: VCO2/VO2)
Measure: Change of assessment of respiratory quotient (RQ) Time: The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatmentDescription: Assessment of resting energy expenditure (REE) with indirect calorimetry (Unit J/s)
Measure: Change of assessment of resting energy expenditure (REE) Time: The outcome will be measured after 3 months of placebo treatment and after 3 months of melatonin treatment