Ignite Creation Date:
2024-05-06 @ 12:49 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03859934
Status:
COMPLETED
Last Update Posted:
2021-08-25
First Post:
2019-02-18
Brief Title:
Metabolic Effects of Melatonin Treatment
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Metabolic Effects of Melatonin Treatment
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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
Main research questions
1 Does chronic melatonin treatment change insulin secretion in T2DM patients
2 Does chronic melatonin treatment change insulin sensitivity in T2DM patients
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
4 Does chronic melatonin treatment change insulin signalling in muscle - and adipose tissue Design A randomized double-blinded placebo controlled crossover study including 18 participants with T2DM We aim to recruit 9 homozygous carriers of the normal allele and 9 hetero - or homozygous for the risk allele
Participants will be examined on two occasions 1 after 3 months of daily melatonin treatment before bedtime 10 mg and 2 after 3 months of daily placebo treatment before bedtime
On the study days participants will initially undergo a basal period with glucose - and palmitate tracer infusions to assess endogenous glucose production and free fatty acid production Afterwards a Botnia clamp which combines an intravenous glucose tolerance test and a hyperinsulinemic euglycemic clamp will be performed to assess β-cell function and insulin sensitivity On both study days muscle - and fat biopsies will be performed under both basal and hyperinsulinemic euglycemic conditions
Perspectives It is highly relevant to evaluate the chronic effects of melatonin on glucose - and fat metabolism given the increase in melatonin consumption Furthermore the study may open for new treatment options of T2DM if beneficial effects of oral melatonin are detected
Main research questions
1 Does chronic melatonin treatment change insulin secretion in T2DM patients
2 Does chronic melatonin treatment change insulin sensitivity in T2DM patients
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
4 Does chronic melatonin treatment change insulin signalling in muscle - and adipose tissue Design A randomized double-blinded placebo controlled crossover study including 18 participants with T2DM We aim to recruit 9 homozygous carriers of the normal allele and 9 hetero - or homozygous for the risk allele
Participants will be examined on two occasions 1 after 3 months of daily melatonin treatment before bedtime 10 mg and 2 after 3 months of daily placebo treatment before bedtime
On the study days participants will initially undergo a basal period with glucose - and palmitate tracer infusions to assess endogenous glucose production and free fatty acid production Afterwards a Botnia clamp which combines an intravenous glucose tolerance test and a hyperinsulinemic euglycemic clamp will be performed to assess β-cell function and insulin sensitivity On both study days muscle - and fat biopsies will be performed under both basal and hyperinsulinemic euglycemic conditions
Perspectives It is highly relevant to evaluate the chronic effects of melatonin on glucose - and fat metabolism given the increase in melatonin consumption Furthermore the study may open for new treatment options of T2DM if beneficial effects of oral melatonin are detected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None