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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

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

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Испания · 1 центр

• CAP Sant Rafael — Barcelona

Публикации

• 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

Идентификаторы

NCT: NCT06081387 · DIAVITEX-1.9

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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