Back to resultsStudy Protocol About the Effect of Training and Vit.D Supplementation on Lipid Profile in Patients With Type 2 Diabetes (DIAVITEX)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Vitamin D
Resistance training
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Vitamin D, Aerobic training, Resistance training, Insulin resistance
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Training and Vitamin D supplementation
Training with placebo
Vitamin D supplementation
Placebo
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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
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)).
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.
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.
Change in weight
Anthropometric measurements (weight in kilograms)
Change in waist circumference
Anthropometric measurements (waist circumference in centimetre)
Change in Body Mass Index (BMI)
(BMI [weight and height will be combined to report BMI] in kg/m2
Vitamin D
Determination of Vitamin D levels in blood (ng/mL)
Vitamin D
Determination of Vitamin D levels in blood (ng/mL)
Secondary Outcome Measures
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.
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.
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.
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.
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.
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
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
Full Information
NCT ID
NCT06081387
First Posted
July 6, 2023
Last Updated
October 6, 2023
Sponsor
University Ramon Llull
Collaborators
University of Barcelona, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Faes Farma, S.A., Islamic Azad University, Tehran
1. Study Identification
Unique Protocol Identification Number
NCT06081387
Brief Title
Study Protocol About the Effect of Training and Vit.D Supplementation on Lipid Profile in Patients With Type 2 Diabetes
Acronym
DIAVITEX
Official Title
The Effect of Concurrent Aerobic and Resistance Training and Vitamin D Supplementation on Lipid Profile in Patients With Type 2 Diabetes: a Study Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ramon Llull
Collaborators
University of Barcelona, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Faes Farma, S.A., Islamic Azad University, Tehran
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Vitamin D, Aerobic training, Resistance training, Insulin resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Training and Vitamin D supplementation
Arm Type
Experimental
Arm Description
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.
Arm Title
Training with placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Vitamin D supplementation
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
Hidroferol, Calcidiol levels
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Resistance training
Other Intervention Name(s)
Sarcoplasm stimulating training system, exercise.
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA IR)
Description
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
Title
Change in Homeostasis model assessment of β-cell function (HOMA-β)
Description
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
Title
Change in serum levels of Hemoglobin A1c.
Description
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
Title
Change in serum lipid profile
Description
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
Title
Change in weight
Description
Anthropometric measurements (weight in kilograms)
Time Frame
Beginning of the study and after 4 months
Title
Change in waist circumference
Description
Anthropometric measurements (waist circumference in centimetre)
Time Frame
Beginning of the study and after 4 months
Title
Change in Body Mass Index (BMI)
Description
(BMI [weight and height will be combined to report BMI] in kg/m2
Time Frame
Beginning of the study and after 4 months
Title
Vitamin D
Description
Determination of Vitamin D levels in blood (ng/mL)
Time Frame
Beginning of the study
Title
Vitamin D
Description
Determination of Vitamin D levels in blood (ng/mL)
Time Frame
End of the study (4 Months)
Secondary Outcome Measure Information:
Title
Sociodemographic data
Description
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
Title
Activity degree
Description
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
Title
Activity degree
Description
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)
Title
Psychological Well-being
Description
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
Title
Psychological Well-being
Description
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
End of the study (4 Months)
Title
Food consumption and adherence to the Mediterranean diet
Description
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
Time Frame
Beginning of the study
Title
Food consumption and adherence to the Mediterranean diet
Description
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
Time Frame
End of the study (4 Months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joel Montane, PhD
Phone
932533256
Email
joelmm@blanquerna.url.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Montane, PhD
Organizational Affiliation
Universitat Ramon Llull
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study Protocol About the Effect of Training and Vit.D Supplementation on Lipid Profile in Patients With Type 2 Diabetes
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