Clinical trial NCT06081387: The Effect of Aerobic and Resistance Training in Patients with Type 2 Diabetes on Vitamin D
Official title: The Effect of Aerobic and Resistance Training in Patients with Type 2 Diabetes on Vitamin D: the DIAVITEX Project
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Vitamin D
Aerobic training
Resistance training
Insulin resistance
Lead sponsor: University Ramon Llull
Sponsor class: OTHER
Collaborators: name: University of Barcelona
name: Islamic Azad University, Sanandaj
name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
First posted: 2023-10-13
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. However, the effect of exercise in T2D patients on VitD 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 on 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 examined. 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. Subjects will perform fitness tests, as well as analysis of glycated hemoglobin, insulin resistance, lipid profile and blood inflammatory biomarkers. Nutritional education programs will be designed and provided to all participants. 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.

Eligibility criteria: Inclusion Criteria:

* Adults (females or males) older than 18 years old with a diagnosis of T2D in the clinic database
* Patients only taking metformin with stable medication for the last 3 months

Exclusion Criteria:

* Patients taking other medication different than metformin (including combinations and insulin)
* Patients taking polyvitaminic supplementation at the inclusion for at least, 1 month before the intervention
* Female subjects who are pregnant

Primary outcomes:
measure: Change in Homeostatic Model Assessment of Insulin Resistance (HOMA IR)
timeFrame: Beginning of the study and after 4 months
measure: Change in Homeostasis model assessment of β-cell function (HOMA-β)
timeFrame: Beginning of the study and after 4 months
measure: Change in serum levels of Hemoglobin A1c.
timeFrame: Beginning of the study and after 4 months
measure: Change in serum lipid profile
timeFrame: Beginning of the study and after 4 months
measure: Change in weight
timeFrame: Beginning of the study and after 4 months
measure: Change in waist circumference
timeFrame: Beginning of the study and after 4 months
measure: Change in Body Mass Index (BMI)
timeFrame: Beginning of the study and after 4 months
measure: Vitamin D
timeFrame: Beginning of the study
measure: Vitamin D
timeFrame: End of the study (4 Months)
Secondary outcomes:
measure: Sociodemographic data
timeFrame: Beginning of the study
measure: Activity degree
timeFrame: Beginning of the study
measure: Activity degree
timeFrame: End of the study (4 Months)
measure: Psychological Well-being
timeFrame: Beginning of the study
measure: Psychological Well-being
timeFrame: End of the study (4 Months)
measure: Food consumption and adherence to the Mediterranean diet
timeFrame: Beginning of the study
measure: Food consumption and adherence to the Mediterranean diet
timeFrame: End of the study (4 Months)
Other outcomes:
Locations:
Study officials:
affiliation: Universitat Ramon Llull
name: Joel Montane, PhD
role: PRINCIPAL_INVESTIGATOR
References: