NCT06748963 Fasted Exercise Training in Type 1 Diabetes (FED-T1D)
| NCT ID | NCT06748963 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alberta |
| Condition | Diabetes Mellitus, Type 1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-01-01 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study compares aerobic exercise training performed before breakfast (i.e., in the fasted state) to similar training performed after breakfast in people with type 1 diabetes. Training will take place over 12 weeks.
Eligibility 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).
Contact & Investigator
Normand G Boule, PhD
PRINCIPAL INVESTIGATOR
University of Alberta
Frequently Asked Questions
Who can join the NCT06748963 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Diabetes Mellitus, Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06748963 currently recruiting?
Yes, NCT06748963 is actively recruiting participants. Contact the research team at nboule@ualberta.ca for enrollment information.
Where is the NCT06748963 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT06748963 clinical trial?
NCT06748963 is sponsored by University of Alberta. The principal investigator is Normand G Boule, PhD at University of Alberta. The trial plans to enroll 20 participants.
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