The Effect of Aerobic and Resistance Training in Patients With Type 2 Diabetes on Vitamin D Treatment: the DIAVITEX Project
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- University Ramon Llull
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change in serum levels of Hemoglobin A1c.
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
The purpose of this study protocol is to assess the effect of concurrent aerobic and resistance training in patients with type 2 diabetes on vitamin D treatment
Detailed Description
Aerobic and resistance training can effectively improve clinical management in people with type 2 diabetes (T2D), leading to improvements in various health parameters, including cardiovascular health, insulin sensitivity, and muscle mass. Low vitamin D (VitD) levels are associated with T2D risk and metabolic disturbances, and some studies suggest that VitD may help reduce this risk, particularly in individuals with low VitD levels. In this line, it is widely recognized that many individuals with T2D, who may also be elderly or have osteoporosis, regularly include vitamin D treatment in their healthcare routines. Although the impact of exercise has been extensively studied, its effect on diabetic patients taking vitamin D remains inconclusive due to limited and inconsistent research findings. The aim of this study is to investigate the effect of aerobic and resistance training on clinical parameters in patients with T2D already taking VitD. The DIAVITEX study is a double-blind randomized clinical trial, including 80 individuals of both sexes (female, male) with a confirmed diagnosis of T2D and on a VitD treatment where a combination of exercises will be performed. Patients will be selected at the Primary Care Centers assigned for the study and randomly assigned to four groups: 1-Training-VitD (n=20); 2- Training (n=20), 3- VitD (n=20) and 4- No VitD (n=20). In this study, a sarcoplasm stimulating training program will be carried out online, three sessions per week for a total of 16 weeks. Before and after the physical activity subjects will perform fitness tests, as well as analysis of glycated hemoglobin, insulin resistance, lipid profile and blood inflammatory biomarkers. Nutritional education programs based on the Spanish Society of Diabetes will be provided to all participants to normalize their diets for study consistency. Expected improvements in insulin resistance, glycated hemoglobin, lipid profile, and inflammatory markers are anticipated following a 16-week regimen of exercise in patients with T2D on VitD.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults (females or males) older than 18 years old with a diagnosis of T2D in the clinic database
- •Patients who have been taking the combination therapy of metformin + sodium-glucose transport protein 2 inhibitors (iSGLT2), as recommended by the redGDPS 2023, with stable medication for the past 6 months.
- •Diabetic patients taking prescribed VitD treatment for at least 6 months (intervention group) and diabetic patients not taking prescribed VitD (control group)
- •Patients who signed the informed consent
- •Patients capable of performing mild to moderate physical activity (to walk steadily and independently for at least 6 minutes)
Exclusion Criteria
- •Patients taking other medication different than metformin + iSGLT2 (including combinations and insulin)
- •Patients taking polyvitaminic supplementation at the inclusion for at least, 1 month before the intervention
- •Female subjects who are pregnant
- •Patients who did not sign the informed consent
Outcomes
Primary Outcomes
Change in serum levels of Hemoglobin A1c.
Time Frame: Beginning of the study and after 4 months
Serum levels of hemoglobin A1c will be tested in the laboratory from blood draws conducted at initial visit from a fasting blood sample.
Change in serum lipid profile
Time Frame: Beginning of the study and after 4 months
Total cholesterol and High-density lipoprotein (HDL) cholesterol and triglyceride levels (mg/dL). Analysis ill be performed by the fully automatic Mindray BS380 using photometry-fixed time and point turbidimetry.
Change in weight
Time Frame: Beginning of the study and after 4 months
Anthropometric measurements (weight in kilograms)
Change in Homeostasis model assessment of β-cell function (HOMA-β)
Time Frame: Beginning of the study and after 4 months
The HOMA-B index will be used to quantify the pancreatic beta cells function (HOMA-B360 x fasting insulin (μU/mL) / (fasting glucose (mg/dL) - 63)).
Vitamin D
Time Frame: End of the study (4 Months)
Determination of Vitamin D levels in blood (ng/mL)
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA IR)
Time Frame: Beginning of the study and after 4 months
HOMA-IR index will be calculated by using formula (HOMA-IR=fasting glucose in mmol/l\*fasting insulin in μU/ml/22.5) to determine insulin resistance
Change in Body Mass Index (BMI)
Time Frame: Beginning of the study and after 4 months
(BMI \[weight and height will be combined to report BMI\] in kg/m2
Change in waist circumference
Time Frame: Beginning of the study and after 4 months
Anthropometric measurements (waist circumference in centimetre)
Secondary Outcomes
- Sociodemographic data(Beginning of the study)
- Activity degree(End of the study (4 Months))
- Food consumption and adherence to the Mediterranean diet(End of the study (4 Months))
- Psychological Well-being(End of the study (4 Months))