Aerobic plus resistance exercise for adults with type 2 diabetes who take vitamin D
The Effect of Aerobic and Resistance Training in Patients With Type 2 Diabetes on Vitamin D Treatment: the DIAVITEX Project
NA · University Ramon Llull · NCT06081387
This trial tests whether adding regular aerobic and resistance exercise improves health measures in adults with type 2 diabetes who are already taking vitamin D.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University Ramon Llull (other) |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06081387 on ClinicalTrials.gov |
What this trial studies
The DIAVITEX trial randomizes 80 adults with type 2 diabetes on stable metformin plus SGLT2 inhibitor therapy into four groups: combined training with vitamin D, training alone, vitamin D alone, or neither. Participants will follow a supervised sarcoplasm-stimulating online exercise program three times per week while continuing their usual medications, with clinical measures taken before and after the intervention. The study is double-blind and enrolls patients from participating primary care centers in Barcelona to clarify how exercise interacts with ongoing vitamin D treatment in this population.
Who should consider this trial
Good fit: Adults with type 2 diabetes on a stable metformin plus SGLT2 inhibitor regimen who can walk steadily for at least six minutes and either are taking or not taking prescribed vitamin D.
Not a fit: Patients using insulin or other glucose-lowering medications, taking multivitamin supplements, pregnant women, or those unable to perform mild-to-moderate exercise are unlikely to benefit from or be eligible for this protocol.
Why it matters
Potential benefit: If successful, this could improve blood sugar control, insulin sensitivity, cardiovascular fitness, and muscle strength for people with type 2 diabetes taking vitamin D.
How similar studies have performed: Exercise alone has consistently improved insulin sensitivity and fitness in type 2 diabetes and vitamin D has shown mixed results, but combining exercise with ongoing vitamin D treatment has been little studied and remains inconclusive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * Patients taking other medication different than metformin + iSGLT2 (including combinations and insulin) * Patients taking polyvitaminic supplementation at the inclusion for at least, 1 month before the intervention * Female subjects who are pregnant * Patients who did not sign the informed consent
Where this trial is running
Barcelona
- CAP Sant Rafael — Barcelona, Spain (RECRUITING)
Study contacts
- Principal investigator: Joel Montane, PhD — Universitat Ramon Llull
- Study coordinator: Joel Montane, PhD
- Email: joelmm@blanquerna.url.edu
- Phone: 932533256
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus, Type 2, Vitamin D, Aerobic training, Resistance training, Insulin resistance