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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity Ramon Llull

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Resistance training

    Other intervention

    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.

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Vitamin D treatment and trainingExperimental treatment 1 intervention
Group B: No vitamin D and trainingActive comparator 1 intervention
Group C: Vitamin D treatment and no traininigNo intervention 0 interventions
Group D: No Vitamin D and no trainingNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Beginning of the study and after 4 months
2

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)).

Time frame
Beginning of the study and after 4 months
3

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.

Time frame
Beginning of the study and after 4 months
4

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.

Time frame
Beginning of the study and after 4 months

Secondary outcomes

1

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.

Time frame
Beginning of the study
2

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.

Time frame
Beginning of the study
3

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.

Time frame
End of the study (4 Months)
4

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.

Time frame
Beginning of the study

Other outcomes

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