Clinical Trials in Spain / NCT06081387
Recruiting
Not applicable
The Effect of Aerobic and Resistance Training in Patients With Type 2 Diabetes on Vitamin D Treatment
NCT06081387 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Diabetes Mellitus, Type 2
Investigational drug(s) / intervention(s)
Resistance training
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
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)
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| CAP Sant Rafael | Barcelona | Spain | Recruiting |
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Official registry record
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.
View NCT06081387 on ClinicalTrials.gov ↗ ← All trials in Spain