About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Parallel
Treatments tested in this trial
Resistance training
Other interventionSarcoplasm 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.
Treatment groups
Trial outcomes
Primary outcomes
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
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)).
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.
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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University Ramon Llull
Lead sponsor
University of Barcelona
Collaborator
Islamic Azad University, Sanandaj
Collaborator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborator
Institut Català de la Salut
Collaborator