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Variation in Sleep Time and Glucose Variation in Patients with Type 2 Diabetes Mellitus

Phase 3
Conditions
non-insulin dependent diabetes mellitus
Registration Number
RBR-6wg54rb
Lead Sponsor
niversidade Federal de Minas Gerais
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruitment completed
Sex
Not specified
Target Recruitment
Not specified
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

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

Study & Design

Study Type
Intervention
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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