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Effect of insulin therapy and dietary adjustments on performance during simulated soccer tests in people with type 1 diabetes

Effect of insulin therapy and dietary adjustments on performance during simulated soccer tests in people with type 1 diabetes: study protocol for a randomized, cross-over, double-blinded, controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17447843
Enrollment
16
Registered
2017-01-05
Start date
2017-08-01
Completion date
Unknown
Last updated
2017-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes Nutritional, Metabolic, Endocrine Type 1 diabetes

Interventions

Participants are randomized to receive two interventions in a random order using block-stratified randomization, with random 2-4 sized blocks and stratified by gender. A statistician non-related to th

Sponsors

Asociación Nacional Pro Estudio de la Diabetes, Endocrinología y Metabolismo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 18 years and over 2. More than two years of established T1D diagnosis 3. Stable insulin regimen in the past 6 months indexed by a less than 20% of changes in total insulin daily dose 4. HbA1c less than 9.0% 5. Weekly physical activity of 90 min or more 6. Participation in recreational or competitive soccer-related activities, at least four times per month 7. Able to provide informed consent

Exclusion criteria

Exclusion criteria: 1. Any treatment regimen different from continuous subcutaneous insulin infusion or multiple daily insulin injections 2. Any use of medications (other than insulin) known to affect glycemic control including oral or parenteral steroids (except for inhaled steroids), metformin, SGLT2 inhibitors, GLP.1 agonists, thiazolidinediones, sulfonylureas, DPP-4 inhibitors, or any other oral antidiabetic therapy 3. Detectable C-peptide in serum 4. Cognitive impairment comprising any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor and cognitive testing, not including hypoglycemia unawareness 5. Chronic kidney disease (glomerular filtration rate less than 90 ml·min-1) 6. Chronic liver failure (Child-Pugh B or C) 7. Advanced diabetic retinopathy 8. Pregnancy 9. Color blindness

Design outcomes

Primary

MeasureTime frame
Physical and technical performance in soccer training sessions will be evaluated using the Loughborough Intermittent Shuttle Test – Prescribed and Self-Paced (LIST-P), the Loughborough Soccer Passing Test (LSPT) and the Loughborough Soccer Shooting Test (LSST) at baseline and 3 weeks in each study condition

Secondary

MeasureTime frame
1. Selective attention and mental processing speed are measured using the Stroop Test at baseline and three weeks, and immediately after finishing the soccer exercises and the day after each workout visit in each study condition 2. Sustained attention and psychomotor speed are measured using the Digit Vigilance Test at baseline and three weeks, and immediately after finishing the soccer exercises and the day after each workout visit in each study condition 3. Visuo-spatial short-term memory are measured using the Corsi Block-Tapping Task at baseline and three weeks, and immediately after finishing the soccer exercises and the day after each workout visit in each study condition 4. Visual sustained attention and working memory processes are measured using the Rapid Visual Information Processing task at baseline and three weeks, and immediately after finishing the soccer exercises and the day after each workout visit in each study condition

Countries

Costa Rica

Contacts

Public ContactJavier Calvo
javier.calvo@ucr.ac.cr+506 (0)88856423

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026