first-degree relatives of individuals with type 2 diabetes.
Conditions
Interventions
Trade Name: Circadin
Product Name: melatonin
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: melatonin
CAS Number: 73
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Ability to understand and personally sign and date the informed consent form. • Male and female subjects above the age of 18; • At least one first degree relative with a confirmed diagnosis of type 2 diabetes • No personal history of type 2 diabetes • Absence of clinical symptoms and signs of infection • Absence of systemic disease which may interfere with glucose metabolism. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: • subjects with diabetes on OGTT criteria at baseline will be excluded from study and referred to their primary care physician for advice • Pregnancy or breast feeding; • Illness that makes the subject unlikely to fully complete the study • Evidence of relevant renal insufficiency as indicated by an estimated glomerular filtration rate below 50 ml/min/m2. • Clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests such as ALT, AST, GGT, alkaline phosphatase, or serum bilirubin (2.5 fold above upper limit of reference range). • Known or suspected intolerance or hypersensitivity to the study medication, closely related compounds, or any of the stated ingredients. • Use of melatonin, fluvoxamine, cimetidine, quinolones, carbamazepine, rifampicine, 5-methoxypsoralene or 8-methoxypsoralene within 4 weeks prior to the inclusion into the study. • Clinical symptoms and signs of infection • Subjects who consume more than 750mg caffeine/day (7 regular cups)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary research questions to be investigated in this study are: (1) Does evening melatonin treatment have beneficial effects on markers of cardiometabolic risk factors (blood fats, blood markers of inflammation and blood clotting [thrombosis] and blood pressure) 2)Does evening melatonin treatment have beneficial effects on markers of obesity (body weight, body mass index [BMI], waist circumference) 3)Does evening melatonin treatment have beneficial effects on genetic markers of circadian rhythm patterns in white blood cells 4)does evening melatonin change an individual's perception of their quality of sleep and daily sleeping/waking patterns ;Main Objective: The principal research question to be investigated by this study is: Does evening melatonin treatment have beneficial effects on measures of blood sugar (glucose) regulation.; Primary end point(s): The primary endpoint of the proposed research will be differences in indices of glucose regulation (HbA1c, OGTT, insulin AUC) between intervention and control groups. ;Timepoint(s) of evaluation of this end point: Five time points over 12 months period (3 monthly evaluation) but only 2 time points while on active therapy with IMP. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Measures of vascular inflammatory and thrombotic markers.;Timepoint(s) of evaluation of this end point: Three monthly | — |
Countries
United Kingdom
Contacts
Public ContactAnna Spires
University of Leeds
Outcome results
None listed