non-insulin dependent diabetes mellitus
Conditions
Interventions
This will be an experimental, clinical trial, double-blind placebo controlled study with 30 patients. After the project to be approved by the ethics and research committee of UFMG (COEP), patients who
Sponsors
Universidade Federal de Minas Gerais
Universidade Federal de Minas Gerais
Eligibility
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: This project will include patients diagnosed with diabetes mellitus type 2 for more than one year; age greater than or equal to 40 years; family history of diabetes mellitus type 2; glycosylated haemoglobin between 7 and 10%
Exclusion criteria
Exclusion criteria: Pregnancy; corticosteroids use within less than 3 months; or other medications that elevate glycemia; diseases that significantly alter glycemia stability (renal failure, acute coronary syndrome, cancer, liver failure, among others); uncontrolled diabetes, with polydipsia, polyuria, or weight loss requiring insulin or other drugs; high risk for severe sleep apnea; depression; shift work; epilepsy; refusal to participate in this research at any time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction in capillary blood glucose variability is expected. We will calculate the differences between pre- and postprandial glycemia. we will then make a comparison between the sum of these differences in the period that the patient used melatonin and in the period that he used placebo. We will assess whether this difference was statistically significant using the Student's T test for unpaired samples | — |
Secondary
| Measure | Time frame |
|---|---|
| We will have as a secondary outcome the evaluation of the mean differences in glycemia at each time (fasting and 2 hours after fasting/before lunch and 2 hours after lunch, before dinner and 2 hours after dinner) to understand whether the use of melatonin may affect the variability of blood glucose at some specific time of the day. We will assess whether this difference was statistically significant using the Student's t test for unpaired samples. In order to analyze the effect of melatonin after a greater number of days of use, we will perform a specific analysis of the glycemic variability mentioned on the last day of glycemia measurement in the first and third weeks through the Student's T test of non-paired samples;We will also do a categorical analysis that will take into account the coefficient of variation of blood glucose levels during the use of placebo and during the use of melatonin. We will consider stable when this value is less than 36% and not stable when higher than this value. We will evaluate whether there was a difference in the weeks using melatonin and placebo in relation to this stability criterion defined in the literature, as already mentioned in this text | — |
Countries
Brazil
Contacts
Public ContactAlmir Tavares Junior
Universidade Federal de Minas Gerais
Outcome results
None listed