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

Diabetes Mellitus, Type 2 Clinical Trial

— DIAVITEX  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06081387
• Other study ID #: DIAVITEX-1.6
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University Ramon Llull
• Contact: Joel Montane, PhD
• Phone: 932533256
• Email: joelmm[@]blanquerna.url.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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. However, the effect of exercise in T2D patients on VitD 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 on 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 examined. 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. Subjects will perform fitness tests, as well as analysis of glycated hemoglobin, insulin resistance, lipid profile and blood inflammatory biomarkers. Nutritional education programs will be designed and provided to all participants. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Adults (females or males) older than 18 years old with a diagnosis of T2D in the clinic database

• Patients only taking metformin with stable medication for the last 3 months

Exclusion Criteria:

• Patients taking other medication different than metformin (including combinations and insulin)

• Patients taking polyvitaminic supplementation at the inclusion for at least, 1 month before the intervention

• Female subjects who are pregnant

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Resistance training
Sarcoplasm stimulating training system. This program will run for 15 weeks and three sessions a week. This exercise plan is designed in three 5-week periods.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University Ramon Llull	Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Islamic Azad University, Tehran, University of Barcelona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in Homeostasis model assessment of ß-cell function (HOMA-ß)	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
Primary	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
Primary	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
Primary	Change in weight	Anthropometric measurements (weight in kilograms)	Beginning of the study and after 4 months
Primary	Change in waist circumference	Anthropometric measurements (waist circumference in centimetre)	Beginning of the study and after 4 months
Primary	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
Primary	Vitamin D	Determination of Vitamin D levels in blood (ng/mL)	Beginning of the study
Primary	Vitamin D	Determination of Vitamin D levels in blood (ng/mL)	End of the study (4 Months)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)