Resistance training: Sarcoplasm stimulating training system. This program will run for a total of 16 weeks and three sessions a week. This exercise plan is designed in three 5-week periods plus a familiarization session.
Study 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
Eligibility
Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA IR) — 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 Homeostasis model assessment of β-cell function (HOMA-β) — 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)).
Change in serum levels of Hemoglobin A1c. — 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 — 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 — Beginning of the study and after 4 months Anthropometric measurements (weight in kilograms)
Change in waist circumference — Beginning of the study and after 4 months Anthropometric measurements (waist circumference in centimetre)
Change in Body Mass Index (BMI) — Beginning of the study and after 4 months (BMI \[weight and height will be combined to report BMI\] in kg/m2
Vitamin D — Beginning of the study Determination of Vitamin D levels in blood (ng/mL)
Vitamin D — End of the study (4 Months) Determination of Vitamin D levels in blood (ng/mL)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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