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NCT Number: NCT06081387

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

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CAP Sant Rafael

Barcelona, Spain

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance training

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.

Other names: Sarcoplasm stimulating training system, exercise.

Primary outcomes

  1. 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

  2. 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)).

  3. 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.

  4. 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.

  5. Change in weight

    Time frame: Beginning of the study and after 4 months

    Anthropometric measurements (weight in kilograms)

  6. Change in waist circumference

    Time frame: Beginning of the study and after 4 months

    Anthropometric measurements (waist circumference in centimetre)

  7. 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

  8. Vitamin D

    Time frame: Beginning of the study

    Determination of Vitamin D levels in blood (ng/mL)

  9. Vitamin D

    Time frame: End of the study (4 Months)

    Determination of Vitamin D levels in blood (ng/mL)

Secondary outcomes

  1. Sociodemographic data

    Time frame: Beginning of the study

    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.

  2. Activity degree

    Time frame: Beginning of the study

    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.

  3. Activity degree

    Time frame: End of the study (4 Months)

    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.

  4. Psychological Well-being

    Time frame: Beginning of the study

    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.

  5. Psychological Well-being

    Time frame: End of the study (4 Months)

    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.

  6. Food consumption and adherence to the Mediterranean diet

    Time frame: Beginning of the study

    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

  7. Food consumption and adherence to the Mediterranean diet

    Time frame: End of the study (4 Months)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Joel Montane, PhD

CONTACT

[email protected]

932533256

Sponsors and collaborators

Lead sponsor

University Ramon Llull

Other

Collaborators

  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
  • Institut Català de la Salut
  • Islamic Azad University, Sanandaj
  • University of Barcelona

Registry information

Official study title

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

Acronym: DIAVITEX

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 13, 2023
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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