The Effect of Aerobic and Resistance Training in Patients With Type 2 Diabetes on Vitamin D Treatment

NCT06081387 | Recruiting

• 1 other identifier: DIAVITEX-1.9
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 2

Keywords

Vitamin D; Aerobic training; Resistance training; Insulin resistance

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (7)

• Sociodemographic data

  Beginning of the study

• Activity degree

  Beginning of the study

• Activity degree

  End of the study (4 Months)

• Psychological Well-being

  Beginning of the study

• Psychological Well-being

  End of the study (4 Months)

Study Arms (4)

Vitamin D treatment and training

EXPERIMENTAL

Subjects are type 2 diabetic patients on vitamin D treatment that will recieve a sarcoplasma stimulating training program. This program will run for 16 weeks and three sessions a week. This exercise plan is designed in three 5-week periods and a familiarization week session. In the first intervention 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.

Other: Resistance training

No vitamin D and training

ACTIVE COMPARATOR

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 16 weeks and three sessions a week. This exercise plan is designed in three 5-week periods plus a familiarization session. In the first week of intervention, 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.

Other: Resistance training

Vitamin D treatment and no traininig

NO INTERVENTION

Subjects are type 2 diabetic patients on vitamin D treatment. In this group, no exercise program will be performed.

No Vitamin D and no training

NO INTERVENTION

Subjects are type 2 diabetic patients with no vitamin D treatment and no exericse program

Interventions

Resistance training OTHER

Sarcoplasm stimulating training system. This program will run for a total of 16 weeks and three sessions a week. This exercise plan is designed in three 5-week periods plus a familiarization session.

Also known as: Sarcoplasm stimulating training system, exercise.

No vitamin D and training; Vitamin D treatment and training

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (females or males) older than 18 years old with a diagnosis of T2D in the clinic database
• Patients who have been taking the combination therapy of metformin + sodium-glucose transport protein 2 inhibitors (iSGLT2), as recommended by the redGDPS 2023, with stable medication for the past 6 months.
• Diabetic patients taking prescribed VitD treatment for at least 6 months (intervention group) and diabetic patients not taking prescribed VitD (control group)
• Patients who signed the informed consent
• Patients capable of performing mild to moderate physical activity (to walk steadily and independently for at least 6 minutes)

You may not qualify if:

• Patients taking other medication different than metformin + iSGLT2 (including combinations and insulin)
• Female subjects who are pregnant
• Patients who did not sign the informed consent

Sponsors & Collaborators

• University Ramon Llull: lead
• University of Barcelona: collaborator
• Islamic Azad University, Sanandaj: collaborator
• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: collaborator
• Institut Català de la Salut: collaborator

Study Sites (1)

CAP Sant Rafael

Barcelona, Spain

RECRUITING

Related Publications (1)

• Dardashtipour E, Canivell S, Azarbayjani MA, Fuente-Vidal A, Surroca A, Gascon P, Mestres C, Anton A, Pena-Mateo MJ, Carrillo-Alvarez E, Canudas AM, Guerra-Balic M, Montane J. The effect of aerobic and resistance training in patients with type 2 diabetes on vitamin D (DIAVITEX): a study protocol. Front Public Health. 2026 Jan 5;13:1674293. doi: 10.3389/fpubh.2025.1674293. eCollection 2025.

  PMID: 41561835 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Resistance Training; Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Joel Montane, PhD

  Universitat Ramon Llull

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joel Montane, PhD

CONTACT

932533256; joelmm@blanquerna.url.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: October 13, 2023
• Study Start: October 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)