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

University Ramon Llull

Status

Enrolling

Conditions

Diabetes Mellitus, Type 2

Treatments

Other: Resistance training

Study type

Interventional

Funder types

Other

Identifiers

NCT06081387

DIAVITEX-1.9

Details and patient eligibility

About

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

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 4 patient groups

Vitamin D treatment and training

Experimental group

Description:

Subjects are type 2 diabetic patients on vitamin D treatment that will recieve a sarcoplasma stimulating training program. This program will run for 16 weeks and three sessions a week. This exercise plan is designed in three 5-week periods and a familiarization week session. In the first intervention week, the movements are as follows: 4 sets of eight repetitions with 20 seconds interval of rest between sets will be performed, with 60% of maximum repetitions. In the second week, with increasing intensity, the exercise will be performed with 60% 1RM. The third week, each movement will be performed in 5 sets with 6 repetitions with 20 seconds of rest between Hursts as an interval with 60% of maximum repetitions.

Treatment:

Other: Resistance training

No vitamin D and training

Active Comparator group

Description:

This will include type 2 diabetic patients not being treated with vitamin D. Sarcoplasm stimulating training system will be performed. This program will run for 16 weeks and three sessions a week. This exercise plan is designed in three 5-week periods plus a familiarization session. In the first week of intervention, the movements are as follows: 4 sets of eight repetitions with 20 seconds interval of rest between sets will be performed, with 60% of maximum repetitions. In the second week, with increasing intensity, the exercise will be performed with 60% 1RM. The third week, each movement will be performed in 5 sets with 6 repetitions with 20 seconds of rest between Hursts as an interval with 60% of maximum repetitions.

Treatment:

Other: Resistance training

Vitamin D treatment and no traininig

No Intervention group

Description:

Subjects are type 2 diabetic patients on vitamin D treatment. In this group, no exercise program will be performed.

No Vitamin D and no training

No Intervention group

Description:

Subjects are type 2 diabetic patients with no vitamin D treatment and no exericse program