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New treatment option for Diabetes Mellitus, Type 1
Official title Fasted Exercise Training in Type 1 Diabetes (FED-T1D)
ClinicalTrials.gov ID: NCT06748963
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- Clinical diagnosis of type 1 diabetes for 5 or more years.
- 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...
- Using rapid (e.g., Aspart, Lispro or Glulisine) or ultra-rapid (e.g., FiAsp) acting insulin analogs.
- HbA1c 7.0-9.9%.
- Have BMI of 25 kg/m2 or above
You likely can't join if
- Major complication within the previous 3 months (e.g., severe hypoglycemia requiring assistance, diabetic ketoacidosis, or cardiovascular event).
- Restriction in aerobic or resistance exercise due to significant diabetes complications (e.g., severe peripheral neuropathy, active proliferative...
- Uncontrolled hypertension (e.g., blood pressure \>160 mmHg systolic or \>100 mmHg diastolic).
- Implanted device, material, or having a condition contraindicated to MRI.
- Ongoing pregnancy or breastfeeding.
- Inability to give consent.
See the full eligibility criteria
- Clinical diagnosis of type 1 diabetes for 5 or more years.
- 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...
- Using rapid (e.g., Aspart, Lispro or Glulisine) or ultra-rapid (e.g., FiAsp) acting insulin analogs.
- HbA1c 7.0-9.9%.
- Have BMI of 25 kg/m2 or above
- 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
- No history of stroke, myocardial infarction, or coronary artery disease
- 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...
- Use a CGM in routine diabetes management.
- Major complication within the previous 3 months (e.g., severe hypoglycemia requiring assistance, diabetic ketoacidosis, or cardiovascular event).
- 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...
- Uncontrolled hypertension (e.g., blood pressure \>160 mmHg systolic or \>100 mmHg diastolic).
- Implanted device, material, or having a condition contraindicated to MRI.
- Ongoing pregnancy or breastfeeding.
- Inability to give consent.
- Use of an injection-based insulin therapy (ex. multiple daily injections or combined pump and injection-based delivery).
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.