The Effect of Aerobic and Resistance Training in Patients with Type 2 Diabetes on Vitamin D
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Other: Resistance training
- Registration Number
- NCT06081387
- Lead Sponsor
- University Ramon Llull
- Brief 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
- 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. 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 & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vitamin D treatment and training Resistance training Subjects are type 2 diabetic patients on vitamin D treatment that will recieve a sarcoplasma stimulating training program. This program will run for 15 weeks and three sessions a week. This exercise plan is designed in three 5-week periods. In the first 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. No vitamin D and training Resistance 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 15 weeks and three sessions a week. This exercise plan is designed in three 5-week periods. In the first 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.
- Primary Outcome Measures
Name Time Method Change in serum levels of Hemoglobin A1c. 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.
Change in serum lipid profile 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.
Change in weight Beginning of the study and after 4 months Anthropometric measurements (weight in kilograms)
Change in Homeostasis model assessment of β-cell function (HOMA-β) 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)).
Vitamin D End of the study (4 Months) Determination of Vitamin D levels in blood (ng/mL)
Change in waist circumference Beginning of the study and after 4 months Anthropometric measurements (waist circumference in centimetre)
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA IR) 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
Change in Body Mass Index (BMI) Beginning of the study and after 4 months (BMI \[weight and height will be combined to report BMI\] in kg/m2
- Secondary Outcome Measures
Name Time Method Sociodemographic data 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.
Activity degree 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.Food consumption and adherence to the Mediterranean diet 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
Psychological Well-being 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.