Pre-existing, non-insulin-dependent diabetes mellitus
Conditions
Interventions
This is a clinical study with a pragmatic approach, conducted in parallel and at a single center, with an open-label design. The intervention modalities will include water aerobics and aquatic jogging
Sponsors
Universidade Federal de Santa Catarina
Universidade Federal de Santa Catarina
Eligibility
Age
35 Years to 90 Years
Inclusion criteria
Inclusion criteria: Individuals of both sexes; aged between 35 and 90 years; diagnosis of type 2 diabetes confirmed by laboratory tests or use of hypoglycemic drugs; presentation of a medical certificate authorizing physical exercise; participation in the Physical Training in Aquatic Environments Extension Project for the Control of Type 2 Diabetes
Exclusion criteria
Exclusion criteria: As exclusion criteria, participants cannot have uncontrolled hypertension; be without medical treatment for diabetes; or have clinical, joint, or muscle impairments that prevent them from exercising safely
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For the primary outcome, glycated hemoglobin, a reduction in its levels is expected. Glycated hemoglobin will be assessed from whole blood samples using the High-Performance Liquid Chromatography (HPLC) method on an automated analyzer. Data will be collected before and after the different intervention periods. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvements in the biochemical profile (total cholesterol, LDL, HDL, and triglycerides; fasting glucose; creatinine; urea; uric acid; C-reactive protein; interleukin-6; and interleukin-10) are expected, as assessed through blood sample collection. These outcomes will be measured only if additional financial resources, beyond those currently available for the project, are obtained.;A reduction in systolic and diastolic blood pressure is expected, as assessed by clinical blood pressure measurements. Data will be collected before and after the different intervention periods.;An improvement in functional capacity is expected, as assessed by the sit-and-reach test, the 30-second chair stand test, the 30-second arm curl test, the Timed Up and Go (TUG) test, and the 6-minute walk test. Data will be collected before and after the different intervention periods.;For mental health parameters, sleep quality, quality of life, and the impact of diabetes on patients’ health, improvements are expected in mental health outcomes as assessed by the self-administered Patient Health Questionnaire (PHQ-9), in sleep quality as assessed by the Pittsburgh Sleep Quality Index, in quality of life as assessed by the WHOQOL-8 questionnaire, and in perceived diabetes-related distress as assessed by the Problem Areas in Diabetes (PAID) questionnaire. Data will be collected before and after the different intervention periods.;An improvement in autonomic modulation of the cardiovascular system is expected, as assessed by heart rate variability analysis. Data will be collected before and after the different intervention periods only when qualified evaluators and financial resources are available.;An improvement in vascular function is expected, as determined by measurements of basal blood flow and flow-mediated vasodilation obtained by ultrasonography, in accordance with the most recent recommendations (Thijssen et al., 2019). These data will be collected before and after the different interventio | — |
Countries
Brazil
Contacts
Public ContactRodrigo Delevatti
Universidade Federal de Santa Catarina
Outcome results
None listed