Nutritional, Metabolic, Endocrine
Conditions
Interventions
Functional training combined with melatonin supplementation
functional training combined with placebo supplementation
Placebo supplementation
Sponsors
Research Laboratory Molecular bases of Human Pathology LR19ES13 Faculty of medicine of Sfax
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Persons with type 2 diabetic • BMI>25kg/m2 • Patients under oral anti-diabetic • HbA1C >6,5%
Exclusion criteria
Exclusion criteria: * patient on insulin therapy *3 months before the study: Taking another supplement, antioxidant substances, vitamins or anti-inflammatory drugs * No hormonal treatments or sleeping pills (hypnotics and anxiolytics) two weeks before the study *Taking medication for weight loss *A contraindication or an allergy to melatonin *Smoking and alcoholism *Any contraindication to the practice of a physical activity (serious cardiovascular or pulmonary diseases, an exacerbation of the MS in the 4 weeks preceding the tests) *Pregnant or breastfeeding women in the last six months *Women with irregular menstruation and using oral contraception • Uncontrolled cardiovascular diseases, chronic inflammatory diseases, and Cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -The anthropometric parameters (BMI, body weight, fat and free mass, waist circumference) -Glycemic variability: Continuous Glucose Monitoring System (e.g., estimated HbA1c, hypoglycemia and hyperglycemia episodes, fasting blood glucose, instantaneous blood glucose) -Biological responses: fasting glucose, serum insulin levels, HOMA-IR, CGMS for 14 days; lipid profile (total cholesterol, LDL, HDL, triglyceride, Short-Chain Fatty Acids, glycated hemoglobin (HbA1C); oxidative stress (malondialdehyde (MDA) ,Thiol, glutathione peroxidase (GPx)); vitamin D; Carbonyl protein , Advanced oxidative protein product (AOPP), interleukin 6 (IL-6) hormones (leptin, insulin, melatonin, adiponectin, resistin, cortisol);NFS (e,g., lymphocytes, neutrophil, hematocrits) cellular damage (ASAT, ALAT, CPK, LDH, CRP); immunology and inflammation (IL-6), 6-sulfatoxymelatonin. -Physiological parameters: resting heart rate (HRrest), maximum heart rate (HRmax), Mean Heart Rate (Mean HR), Heart rate variability parameters (Kubios) (e.g., very low frequency (VLF), low frequency (LF), high frequency (HF), Standard Deviation of Normal-to-Normal Intervals (SDNN), Mean R-R Interval (Mean RR)), -Cardiorespiratory fitness: clinical ergocycle (e.g., heart rate (HR), blood pressure (BP)). During the exercise test, we will evaluate oxygenated and deoxygenated hemoglobin muscle (O2Hb and HHb) using near-infrared spectroscopy (NIRS). | — |
Secondary
| Measure | Time frame |
|---|---|
| -Physical capacity: chair test and 30” bicep flexion test, postural balance (force platform), -Quality of life (Medical Outcomes Study Short Form 36 (SF-36)), chronotype (Caen chronotype questionnaire), International Physical Activity Questionnaire (IPAQ), Sleep quality and quantity (Pittsburgh sleep quality index, sleep dairy and actimetry). Psycho-cognitive status (e.g., Montreal Cognitive Assessment (MoCA questionnaire), Hospital Anxiety and Depression Scale (HADS)) , Hunger and Satiety Visual Analogue Scales (VAS),Eating Attitudes Test (EAT 26). | — |
Countries
Tunisia
Contacts
Public ContactDalenda Ibn Elwefi
Molecular bases of Human Pathology LR19ES13 Faculty of medicine of Sfax University of Sfax Tunisia.
Outcome results
None listed