Study Protocol About the Effect of Training and Vit.D Supplementation on Lipid Profile in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study protocol is to assess the effect of concurrent aerobic and resistance training and vitamin D supplementation on lipid profile in patients with type 2 diabetes.

Detailed Description
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A double-blind randomized clinical trial will be done to study the effect of aerobic and resistance training with vitamin D supplementation, in diabetes type 2 patients. To perform it, 4 groups will be done. The first one will take supplements of vitamin D and will do a training program that will run for three sessions per week for a total of 15 weeks. The second group will carry out the training program and take placebo. The third will only take vitamin D supplementation without exercise, and the last group will be the control group, as they will take placebo without a training program. The insulin resistance and lipid profile of patients will be monitored, as the main outcomes. Other parameters measured will be the level of triglycerides, blood cholesterol and the ratio of HDL to LDL.

Official Title
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The Effect of Concurrent Aerobic and Resistance Training and Vitamin D Supplementation on Lipid Profile in Patients With Type 2 Diabetes: a Study Protocol

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Dietary Supplement: Vitamin D
* Other: Resistance training
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age more than 40 Fasting blood glucose higher than 126mg/dL Glycosylated haemoglobin lower than 9% Exclusion Criteria: Have performed a regular physical activity during the last six months (especially resistance training) Smokers Cardiovascular, pulmonary or musculoskeletal diseases Allergic or hypersensitive to vitamin D or any excipient of the formulation

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training and Vitamin D supplementation<br>Subjects in the vitamin D and resistance training group will take oral capsules containing 5,000 international units of vitamin D every two weeks for four months. The tablets will be taken with 250 ml of water at lunch. Sarcoplasm stimulating training system will be used. 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. | Dietary Supplement: Vitamin D<br>* Oral capsules containing 5,000 international units of vitamin D every two weeks for four months. The tablets will be taken with 250 ml of water at lunch.<br>* Other names: Hidroferol, Calcidiol levels;Other: Resistance training<br>* 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.<br>* Other names: Sarcoplasm stimulating training system, exercise.;|
| Placebo Comparator: Training with placebo<br>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. This time, instead of taking a vitamin D capsule, capsules made of paraffin oil will be offered. Capsules designed as a placebo will be indistinguishable in shape and colour from vitamin D capsules. The tablets will be taken with 250 ml of water at lunch. | Other: Resistance training<br>* 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.<br>* Other names: Sarcoplasm stimulating training system, exercise.;Drug: placebo<br>* Capsules made of paraffin oil, designed as a placebo. They will be indistinguishable in shape and colour from vitamin D capsules. The tablets will be taken with 250 ml of water at lunch.<br>* Other names: Control;|
| Experimental: Vitamin D supplementation<br>In this group, no exercise program will be performed. They will take oral capsules containing 5,000 international units of vitamin D every two weeks for four months. The tablets will be taken with 250 ml of water at lunch. | Dietary Supplement: Vitamin D<br>* Oral capsules containing 5,000 international units of vitamin D every two weeks for four months. The tablets will be taken with 250 ml of water at lunch.<br>* Other names: Hidroferol, Calcidiol levels;|
| Placebo Comparator: Placebo<br>The control group will only take the placebo capsule: capsules made of paraffin oil will be offered. Capsules designed as a placebo will be indistinguishable in shape and colour from vitamin D capsules. The tablets will be taken with 250 ml of water at lunch. | Drug: placebo<br>* Capsules made of paraffin oil, designed as a placebo. They will be indistinguishable in shape and colour from vitamin D capsules. The tablets will be taken with 250 ml of water at lunch.<br>* Other names: Control;|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Aerobic training, Resistance training, Insulin resistance