DIAVITEX: Study Protocol About the Effect of Training and Vit.D Supplementation on Lipid Profile in Patients With Type 2 Diabetes
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Training and Vitamin D supplementation 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
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.
Other Names:
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.
Other Names:
|
| Placebo Comparator: Training with placebo 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
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.
Other Names:
Drug: placebo
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.
Other Names:
|
| Experimental: Vitamin D supplementation 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
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.
Other Names:
|
| Placebo Comparator: Placebo 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
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 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)).
- 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 waist circumference [Beginning of the study and after 4 months]
Anthropometric measurements (waist circumference in centimetre)
- 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
- Vitamin D [Beginning of the study]
Determination of Vitamin D levels in blood (ng/mL)
- Vitamin D [End of the study (4 Months)]
Determination of Vitamin D levels in blood (ng/mL)
Secondary Outcome Measures
- 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 [Beginning of the study]
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 [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.
- Psychological Well-being [Beginning of the study]
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.
- 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.
- Food consumption and adherence to the Mediterranean diet [Beginning of the study]
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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age more than 40
-
Fasting blood glucose higher than 126mg/dL
-
Glycosylated haemoglobin lower than 9%
Exclusion Criteria:
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Have performed a regular physical activity during the last six months (especially resistance training)
-
Smokers
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Cardiovascular, pulmonary or musculoskeletal diseases
-
Allergic or hypersensitive to vitamin D or any excipient of the formulation
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Ramon Llull
- University of Barcelona
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Faes Farma, S.A.
- Islamic Azad University, Tehran
Investigators
- Principal Investigator: Joel Montane, PhD, Universitat Ramon Llull
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DIAVITEX-1.1