The Effect of Aerobic and Resistance Training in Patients With Type 2 Diabetes on Vitamin D Treatment

Official title

The Effect of Aerobic and Resistance Training in Patients With Type 2 Diabetes on Vitamin D Treatment: the DIAVITEX Project

Overview

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.

Interventions

• Other 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.

Primary outcome measures

• Change in Homeostatic Model Assessment of Insulin Resistance (HOMA IR) [Time frame: Beginning of the study and after 4 months]
• Change in Homeostasis model assessment of β-cell function (HOMA-β) [Time frame: Beginning of the study and after 4 months]
• Change in serum levels of Hemoglobin A1c. [Time frame: Beginning of the study and after 4 months]
• Change in serum lipid profile [Time frame: Beginning of the study and after 4 months]
• Change in weight [Time frame: Beginning of the study and after 4 months]
• Change in waist circumference [Time frame: Beginning of the study and after 4 months]
• Change in Body Mass Index (BMI) [Time frame: Beginning of the study and after 4 months]
• Vitamin D [Time frame: Beginning of the study]
• Vitamin D [Time frame: End of the study (4 Months)]

Secondary outcome measures (7)

• Sociodemographic data [Time frame: Beginning of the study]
• Activity degree [Time frame: Beginning of the study]
• Activity degree [Time frame: End of the study (4 Months)]
• Psychological Well-being [Time frame: Beginning of the study]
• Psychological Well-being [Time frame: End of the study (4 Months)]
• Food consumption and adherence to the Mediterranean diet [Time frame: Beginning of the study]
• Food consumption and adherence to the Mediterranean diet [Time frame: End of the study (4 Months)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Spain · 1 center

• CAP Sant Rafael — Barcelona

Publications

• Dardashtipour E, Canivell S, Azarbayjani MA, Fuente-Vidal A, Surroca A, Gascon P, Mestres C, Anton A, Pena-Mateo MJ, Carrillo-Alvarez E, Canudas AM, Guerra-Balic M, Montane J. The effect of aerobic and resistance training in patients with type 2 diabetes on vitamin D (DIAVITEX): a study protocol. Front Public Health. 2026 Jan 5;13:1674293. doi: 10.3389/fpubh.2025.1674293. eCollection 2025. PMID 41561835

Identifiers

NCT: NCT06081387 · DIAVITEX-1.9

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗