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

October 6, 2023 updated by: University Ramon Llull

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

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.

Study Overview

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.
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:
  • Hidroferol, Calcidiol levels
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:
  • Sarcoplasm stimulating training system, exercise.
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.
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:
  • Sarcoplasm stimulating training system, exercise.
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:
  • Control
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.
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:
  • Hidroferol, Calcidiol levels
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.
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:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA IR)
Time Frame: 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
Beginning of the study and after 4 months
Change in Homeostasis model assessment of β-cell function (HOMA-β)
Time Frame: 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)).
Beginning of the study and after 4 months
Change in serum levels of Hemoglobin A1c.
Time Frame: 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.
Beginning of the study and after 4 months
Change in serum lipid profile
Time Frame: 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.
Beginning of the study and after 4 months
Change in weight
Time Frame: Beginning of the study and after 4 months
Anthropometric measurements (weight in kilograms)
Beginning of the study and after 4 months
Change in waist circumference
Time Frame: Beginning of the study and after 4 months
Anthropometric measurements (waist circumference in centimetre)
Beginning of the study and after 4 months
Change in Body Mass Index (BMI)
Time Frame: Beginning of the study and after 4 months
(BMI [weight and height will be combined to report BMI] in kg/m2
Beginning of the study and after 4 months
Vitamin D
Time Frame: Beginning of the study
Determination of Vitamin D levels in blood (ng/mL)
Beginning of the study
Vitamin D
Time Frame: End of the study (4 Months)
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
Time Frame: 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.
Beginning of the study
Activity degree
Time Frame: 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.

Beginning of the study
Activity degree
Time Frame: 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.

End of the study (4 Months)
Psychological Well-being
Time Frame: 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.

Beginning of the study
Psychological Well-being
Time Frame: 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.

End of the study (4 Months)
Food consumption and adherence to the Mediterranean diet
Time Frame: 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
Beginning of the study
Food consumption and adherence to the Mediterranean diet
Time Frame: 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
End of the study (4 Months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Joel Montane, PhD, Universitat Ramon Llull

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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