Fasted Exercise Training in Type 1 Diabetes (FED-T1D)

Last updated: January 23, 2025
Sponsor: University of Alberta
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 1

Diabetes Prevention

Diabetes And Hypertension

Treatment

Postprandial Exercise

Fasted Exercise

Clinical Study ID

NCT06748963
Pro00140125
RES0067483
  • Ages 18-55
  • All Genders

Study 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

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 > 2continuous months and willing to share CGM data with the research team. Insulindelivery can be managed using either manual open-loop system (non-AID) or a hybridclosed loop (AID) systems.

  3. Using rapid (e.g., Aspart, Lispro or Glulisine) or ultra-rapid (e.g., FiAsp) actinginsulin 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 perDiabetes Canada definition

  • 94cm for males of European, Sub-Saharan African, Eastern Mediterranean andMiddle Eastern descent

  • 90cm for males of South Asian, Chinese, Japanese, South and Central Americandescent

  • 80cm for females

  1. No history of stroke, myocardial infarction, or coronary artery disease

  2. Not wearing implantable device such as a pacemaker, neurostimulators, aneurysmclips, metal fragments, epicardial electrodes, cochlear implants, magnetic ocularimplants, penile implants, magnetic tissue expander, some types of breast implants,magnetic orthopedic implants, magnetic dental implants, hearing Aids, intravascularimplants, for example VCI filters, coils, stents, cardiac septum implants,ventricular bypass devices.

  3. Use a CGM in routine diabetes management.

Exclusion

Exclusion Criteria:

  1. Major complication within the previous 3 months (e.g., severe hypoglycemia requiringassistance, diabetic ketoacidosis, or cardiovascular event).

  2. Restriction in aerobic or resistance exercise due to significant diabetescomplications (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 mmHgdiastolic).

  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 combinedpump and injection-based delivery).

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Postprandial Exercise
Phase:
Study Start date:
January 01, 2025
Estimated Completion Date:
April 30, 2026

Study Description

People with type 1 diabetes (PwT1D) are encouraged to increase their physical activity (PA). Increasing the amount of PA can be difficult, especially for PwT1D who experience barriers to exercise. Therefore, simply recommending that PwT1D preform more exercise may not be the most effective prescription in the long term. Recent short-term studies have s suggest that exercise performed before eating (fasted) causes blood sugars to decrease less or even increase, compared exercise performed after a meal, which usually causes blood sugar to decrease. To date, no long-term study has compared the effects of exercise performed with or without eating beforehand in people with T1D.

This study will compare the effects of 12 weeks of exercise before breakfast compared to 12 weeks of exercise after breakfast. It is expected that exercise before breakfast (i.e., in the fasted state) will lead to larger reductions in overall insulin dose, without the addition of more exercise.

Connect with a study center

  • University of Alberta

    Edmonton, Alberta T6G 2E1
    Canada

    Active - Recruiting

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