Diabetes Mellitus, Type 2DIAVITEXNCT06081387
The Effect of Aerobic and Resistance Training in Patients With Type 2 Diabetes on Vitamin D Treatment
A study testing Resistance training in people with Diabetes Mellitus, Type 2, run by University Ramon Llull at 1 site in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Aerobic and Resistance Training in Patients With Type 2 Diabetes on Vitamin D Treatment: the DIAVITEX Project
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
Read the 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
- Being tested
- Resistance training
- Keywords
- Vitamin D, Aerobic training, Resistance training, Insulin resistance
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingOther
Also called Sarcoplasm stimulating training system, exercise.
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.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D treatment and training | Experimental | 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. Receives: Other: Resistance training |
| No vitamin D and training | Active comparator | 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. Receives: Other: Resistance training |
| Vitamin D treatment and no traininig | No intervention | 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 | Subjects are type 2 diabetic patients with no vitamin D treatment and no exericse program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA IR)
HOMA-IR index will be calculated by using formula (HOMA-IR=fasting glucose in mmol/l*fasting insulin in μU/ml/22.5) to determine insulin resistance
Measured: Beginning of the study and after 4 months
Change in Homeostasis model assessment of β-cell function (HOMA-β)
The HOMA-B index will be used to quantify the pancreatic beta cells function (HOMA-B360 x fasting insulin (μU/mL) / (fasting glucose (mg/dL) - 63)).
Measured: Beginning of the study and after 4 months
Change in serum levels of Hemoglobin A1c.
Serum levels of hemoglobin A1c will be tested in the laboratory from blood draws conducted at initial visit from a fasting blood sample.
Measured: Beginning of the study and after 4 months
Change in serum lipid profile
Total cholesterol and High-density lipoprotein (HDL) cholesterol and triglyceride levels (mg/dL). Analysis ill be performed by the fully automatic Mindray BS380 using photometry-fixed time and point turbidimetry.
Measured: Beginning of the study and after 4 months
Change in weight
Anthropometric measurements (weight in kilograms)
Measured: Beginning of the study and after 4 months
Change in waist circumference
Anthropometric measurements (waist circumference in centimetre)
Measured: Beginning of the study and after 4 months
Change in Body Mass Index (BMI)
(BMI [weight and height will be combined to report BMI] in kg/m2
Measured: Beginning of the study and after 4 months
Vitamin D
Determination of Vitamin D levels in blood (ng/mL)
Measured: Beginning of the study
Vitamin D
Determination of Vitamin D levels in blood (ng/mL)
Measured: End of the study (4 Months)
Secondary outcomes (7)
Sociodemographic data
Sociodemographic data (age, sex, ethnicity, occupation, employment status, education level, household income, alcohol intake, smoking status, current medications, family medical history, current medications taken) via questionnaire. Additionally, participants may be required to list answers to the questions e.g. list any current medications taken or age. This will all be measured in the baseline case report form.
Measured: Beginning of the study
Activity degree
To evaluate the degree of activity, the International Physical Activity Questionnaire (IPAQ) will be administered to measure the physical activity, which through an interview assessing different items will allow to obtain the usual physical activity, being able to classify individuals in sedentary, moderate sedentary or active lifestyles.
The IPAQ questionnaires quantifies the activity: "walk", "activities of moderate intensity" and "vigorous intensity activities" assigned to each activity about energy requirements defined in metabolic equivalent tasks (METs), being multiples of the rate of metabolic rate equivalent to kilocalories for a 60 kg.
Measured: Beginning of the study
Activity degree
To evaluate the degree of activity, the International Physical Activity Questionnaire (IPAQ) will be administered to measure the physical activity, which through an interview assessing different items will allow to obtain the usual physical activity, being able to classify individuals in sedentary, moderate sedentary or active lifestyles.
The IPAQ questionnaires quantifies the activity: "walk", "activities of moderate intensity" and "vigorous intensity activities" assigned to each activity about energy requirements defined in metabolic equivalent tasks (METs), being multiples of the rate of metabolic rate equivalent to kilocalories for a 60 kg.
Measured: End of the study (4 Months)
Psychological Well-being
The psychological subjective welfare will be measured through the Psychological Well-being Index, which refers to happiness or well-being.
A 42-item self-rating scale, which includes six dimensions: self-acceptance, positive relations with others, autonomy, environmental mastery, purpose in life and personal growth. The respondents are asked to indicate on a 6-likert scale the extent to which they agree with each statement. Each dimension may range from 7-42, with higher scores indicating greater psychological well-being.
Measured: Beginning of the study
Psychological Well-being
The psychological subjective welfare will be measured through the Psychological Well-being Index, which refers to happiness or well-being.
A 42-item self-rating scale, which includes six dimensions: self-acceptance, positive relations with others, autonomy, environmental mastery, purpose in life and personal growth. The respondents are asked to indicate on a 6-likert scale the extent to which they agree with each statement. Each dimension may range from 7-42, with higher scores indicating greater psychological well-being.
Measured: End of the study (4 Months)
Food consumption and adherence to the Mediterranean diet
A 14-item questionnaire designed to assess adherence to the traditional Mediterranean Diet will be administered. Values of 0 or 1 are assigned to each item, the maximum adherence to the Mediterranean Diet is indicated by a 14-point score. A validated food frequency questionnaire with 140 items will also be administered
Measured: Beginning of the study
Food consumption and adherence to the Mediterranean diet
A 14-item questionnaire designed to assess adherence to the traditional Mediterranean Diet will be administered. Values of 0 or 1 are assigned to each item, the maximum adherence to the Mediterranean Diet is indicated by a 14-point score. A validated food frequency questionnaire with 140 items will also be administered
Measured: End of the study (4 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start1 Oct 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ramon Llull
- Sponsor type
- University, hospital or other
- Collaborators
- University of Barcelona, Islamic Azad University, Sanandaj, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Institut Català de la Salut
- Responsible party
- Sponsor
- Investigators
- Joel Montane, PhD, Principal investigator, Universitat Ramon Llull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081387
- Sponsor's protocol ID
- DIAVITEX-1.9
- Acronym
- DIAVITEX
- Status last verified
- May 2025
- First submitted
- 6 Jul 2023
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41561835
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aerobic and Resistance Training in Patients With Type 2 Diabetes on Vitamin D Treatment: the DIAVITEX Project
- ClinicalTrials.gov ID
- NCT06081387
- Acronym / sponsor ID
- DIAVITEX / DIAVITEX-1.9
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Vitamin D, Aerobic training, Resistance training, Insulin resistance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Ramon LlullUniversity, hospital or other
- Collaborators
- University of Barcelona, Islamic Azad University, Sanandaj, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Institut Català de la Salut
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitamin D treatment and training | Experimental | Other: Resistance trainingSubjects 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. |
| No vitamin D and training | Active comparator | Other: Resistance trainingThis 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. |
| Vitamin D treatment and no traininig | No intervention | –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 | –Subjects are type 2 diabetic patients with no vitamin D treatment and no exericse program |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance trainingAlso: Sarcoplasm stimulating training system, exercise.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. | Other | No vitamin D and training, Vitamin D treatment and training |
Primary outcome
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA IR)
Time frame: Beginning of the study and after 4 months
HOMA-IR index will be calculated by using formula (HOMA-IR=fasting glucose in mmol/l*fasting insulin in μU/ml/22.5) to determine insulin resistance
Change in Homeostasis model assessment of β-cell function (HOMA-β)
Time frame: Beginning of the study and after 4 months
The HOMA-B index will be used to quantify the pancreatic beta cells function (HOMA-B360 x fasting insulin (μU/mL) / (fasting glucose (mg/dL) - 63)).
Change in serum levels of Hemoglobin A1c.
Time frame: Beginning of the study and after 4 months
Serum levels of hemoglobin A1c will be tested in the laboratory from blood draws conducted at initial visit from a fasting blood sample.
Change in serum lipid profile
Time frame: Beginning of the study and after 4 months
Total cholesterol and High-density lipoprotein (HDL) cholesterol and triglyceride levels (mg/dL). Analysis ill be performed by the fully automatic Mindray BS380 using photometry-fixed time and point turbidimetry.
Change in weight
Time frame: Beginning of the study and after 4 months
Anthropometric measurements (weight in kilograms)
Change in waist circumference
Time frame: Beginning of the study and after 4 months
Anthropometric measurements (waist circumference in centimetre)
Change in Body Mass Index (BMI)
Time frame: Beginning of the study and after 4 months
(BMI [weight and height will be combined to report BMI] in kg/m2
Vitamin D
Time frame: Beginning of the study
Determination of Vitamin D levels in blood (ng/mL)
Vitamin D
Time frame: End of the study (4 Months)
Determination of Vitamin D levels in blood (ng/mL)
7 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Derived from this study: PubMed 41561835Dardashtipour 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joel Montane, PhD principal investigator
Universitat Ramon Llull
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in people with Diabetes Mellitus, Type 2, run by University Ramon Llull at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joel Montane, PhD (932533256, joelmm@blanquerna.url.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA IR) (time frame: Beginning of the study and after 4 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06081387, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.