Nutritional, Metabolic, Endocrine
Conditions
Interventions
Interval functional training combined with melatonin supplementation
Interval functional training combined with placebo supplementation
Sponsors
Endocrinology department of Hadi Chaker University Hospital
Research Laboratory Molecular bases of Human Pathology LR19ES13 Faculty of medicine of Sfax
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Persons with type 1 diabetic • BMI kg/m2 • Patients on insulin therapy • HbA1C >6,5%
Exclusion criteria
Exclusion criteria: *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 |
|---|---|
| -Physical capacity: chair test, hand grip, postural balance (y-balance test and Single Leg Stance (SLS)) -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) -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)), Sleep quality and quantity (Pittsburgh sleep quality index, sleep dairy and actimetry). -Cardiorespiratory capacity: Six-Minute Walk Test | — |
Secondary
| Measure | Time frame |
|---|---|
| -Quality of life (Medical Outcomes Study Short Form 36 (SF-36)), chronotype (Caen chronotype questionnaire), barrier to physical activity in individuals with type 1 diabetes (BAPAD-1), Montreal Cognitive Assessment (MoCA questionnaire), Hunger and Satiety Visual Analogue Scales (VAS), Hypoglycemia Symptom Perception Questionnaire (Clarke Scale), Eating Attitudes Test (EAT 26). | — |
Countries
Tunisia
Contacts
Public Contactdalenda ibn wefi
Molecular bases of Human Pathology LR19ES13 Faculty of medicine of Sfax University of Sfax Tunisia.
Outcome results
None listed