Comparing fasted and post-meal exercise in people with type 1 diabetes
Exercise Training Before (Fasted) Versus After (Fed) Breakfast in Type 1 Diabetes
This study tests whether exercising before meals helps people with type 1 diabetes manage their blood sugar better and use less insulin compared to exercising after meals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT06748963 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of aerobic exercise training performed in a fasted state versus after a meal in individuals with type 1 diabetes over a 12-week period. Participants will engage in exercise routines while monitoring their continuous glucose levels and insulin doses. The goal is to determine whether exercising before breakfast leads to better management of blood sugar levels and reduced insulin requirements compared to exercising after meals. This long-term comparison aims to provide insights into optimizing exercise recommendations for people with type 1 diabetes.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with type 1 diabetes for at least five years, using an insulin pump, and meeting specific metabolic criteria.
Not a fit: Patients with a history of cardiovascular issues or those using implantable devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help individuals with type 1 diabetes manage their condition more effectively by optimizing exercise timing and reducing insulin doses.
How similar studies have performed: While some short-term studies have suggested benefits of fasted exercise, this long-term comparison is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Clinical diagnosis of type 1 diabetes for 5 or more years. 2. Treatment using an insulin pump with no change in treatment modality for \> 2 continuous months and willing to share CGM data with the research team. Insulin delivery can be managed using either manual open-loop system (non-AID) or a hybrid closed loop (AID) systems. 3. Using rapid (e.g., Aspart, Lispro or Glulisine) or ultra-rapid (e.g., FiAsp) acting insulin analogs. 4. HbA1c 7.0-9.9%. 5. Have BMI of 25 kg/m2 or above 6. Have waist circumference associated with central obesity/metabolic syndrome as per Diabetes Canada definition * 94cm for males of European, Sub-Saharan African, Eastern Mediterranean and Middle Eastern descent * 90cm for males of South Asian, Chinese, Japanese, South and Central American descent * 80cm for females 7. No history of stroke, myocardial infarction, or coronary artery disease 8. Not wearing implantable device such as a pacemaker, neurostimulators, aneurysm clips, metal fragments, epicardial electrodes, cochlear implants, magnetic ocular implants, penile implants, magnetic tissue expander, some types of breast implants, magnetic orthopedic implants, magnetic dental implants, hearing Aids, intravascular implants, for example VCI filters, coils, stents, cardiac septum implants, ventricular bypass devices. 9. Use a CGM in routine diabetes management. Exclusion Criteria: 1. Major complication within the previous 3 months (e.g., severe hypoglycemia requiring assistance, diabetic ketoacidosis, or cardiovascular event). 2. Restriction in aerobic or resistance exercise due to significant diabetes complications (e.g., severe peripheral neuropathy, active proliferative retinopathy, etc.) or other type of limitations (e.g., orthopedic, severe arthritis, etc.). 3. Uncontrolled hypertension (e.g., blood pressure \>160 mmHg systolic or \>100 mmHg diastolic). 4. Implanted device, material, or having a condition contraindicated to MRI. 5. Ongoing pregnancy or breastfeeding. 6. Inability to give consent. 7. Use of an injection-based insulin therapy (ex. multiple daily injections or combined pump and injection-based delivery).
Where this trial is running
Edmonton, Alberta
- University of Alberta — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Normand G Boule, PhD — University of Alberta
- Study coordinator: Normand Boule, PhD
- Email: nboule@ualberta.ca
- Phone: 780-492-4695
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.