The effects of melatonin treatment on risk for diabetes and heart disease

Phase 1

• Conditions: first-degree relatives of individuals with type 2 diabetes.; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2012-005255-17-GB
• Lead Sponsor: niversity of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-11
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 160

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

•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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified