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

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

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Resistance training

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joel Montane, PhD; Phone Number: 932533256; Email: joelmm@blanquerna.url.edu

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • CAP Sant Rafael

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
No Intervention: No Vitamin D and no training; Subjects are type 2 diabetic patients with no vitamin D treatment and no exericse program
Experimental: 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.	Other: 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.; Other Names: Sarcoplasm stimulating training system, exercise.
Active Comparator: 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.	Other: 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.; Other Names: Sarcoplasm stimulating training system, exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)).	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.	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.	Beginning of the study and after 4 months
Change in weight	Anthropometric measurements (weight in kilograms)	Beginning of the study and after 4 months
Change in waist circumference	Anthropometric measurements (waist circumference in centimetre)	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	Beginning of the study and after 4 months
Vitamin D	Determination of Vitamin D levels in blood (ng/mL)	Beginning of the study
Vitamin D	Determination of Vitamin D levels in blood (ng/mL)	End of the study (4 Months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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	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	End of the study (4 Months)

Collaborators and Investigators

• Sponsor: University Ramon Llull
• Collaborators: Institut Català de la Salut; University of Barcelona; Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina; Islamic Azad University, Sanandaj
• Investigators: Principal Investigator: Joel Montane, PhD, Universitat Ramon Llull

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Vitamin D; Insulin resistance; Aerobic training; Resistance training
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: DIAVITEX-1.9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No