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

NCT ID: NCT06081387

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-12-31

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. 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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Vitamin D treatment and training

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.

Group Type: EXPERIMENTAL

Resistance training

Intervention Type: OTHER

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.

No vitamin D and training

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.

Group Type: ACTIVE_COMPARATOR

Resistance training

Intervention Type: OTHER

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.

Vitamin D treatment and no traininig

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

No Vitamin D and no training

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Sarcoplasm stimulating training system, exercise.

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Barcelona

OTHER

Sponsor Role: collaborator

Islamic Azad University, Sanandaj

OTHER

Sponsor Role: collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: collaborator

Institut Català de la Salut

OTHER

Sponsor Role: collaborator

University Ramon Llull

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joel Montane, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitat Ramon Llull

Locations

CAP Sant Rafael

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Joel Montane, PhD

Role: CONTACT

joelmm@blanquerna.url.edu

932533256

Other Identifiers

DIAVITEX-1.9

Identifier Type: -

Identifier Source: org_study_id