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

NCT06748963 | Recruiting

• 2 other identifiers: Pro00140125RES0067483
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Exercise; Continuous glucose monitoring; total daily insulin dose; Muscle fat; Liver fat

Outcome Measures

Primary Outcomes (1)

• Daily insulin dose (units/kg/day)

  Total daily insulin dose (including basal and bolus insulin) will be measured over 7 consecutive days.

  From enrolment to the end of the exercise intervention at week 12.

Secondary Outcomes (19)

• Continuous glucose monitoring

  From enrolment to the end of the exercise intervention at week 12.

• Continuous glucose monitoring

  From enrolment to the end of the exercise intervention at week 12.

• Magnetic resonance imaging (MRI) volumes

  From enrolment to the end of the exercise intervention at week 12.

• Basal and bolus insulin dose (units/kg/day)

  From enrolment to the end of the exercise intervention at week 12.

• Bioelectrical impedance (BIA) in kilograms

  From enrolment to the end of the exercise intervention at week 12.

Study Arms (2)

Fasted Exercise

EXPERIMENTAL

Exercise training will be performed in the fasted state (i.e., before breakfast).

Behavioral: Fasted Exercise

Postprandial Exercise

ACTIVE COMPARATOR

Exercise will be performed in the postprandial period (i.e., after breakfast)

Behavioral: Postprandial Exercise

Interventions

Fasted Exercise BEHAVIORAL

Participants will complete three sessions of combined resistance-aerobic exercise per week. Sessions will always start with resistance training followed by aerobic training, and will increase in duration throughout the intervention period, so that by the final three weeks of the intervention, all participants accumulate 150 minutes per week of moderate intensity aerobic exercise and 75 minutes of resistance exercise per week. Participants will complete three distinct resistance exercise sessions per week, which will increase in load, but decrease in repetition range throughout the trial. The aerobic component of the exercise sessions will increase in duration from 35 to 50 minutes per session. Participants will walk on a treadmill at a speed and incline that corresponds to 70-80% of ventilatory threshold.

Fasted Exercise

Postprandial Exercise BEHAVIORAL

Participants will complete three sessions of combined resistance-aerobic exercise per week. Sessions will always start with resistance training followed by aerobic training, and will increase in duration throughout the intervention period, so that by the final three weeks of the intervention, all participants accumulate 150 minutes per week of moderate intensity aerobic exercise and 75 minutes of resistance exercise per week. Participants will complete three distinct resistance exercise sessions per week, which will increase in load, but decrease in repetition range throughout the trial. The aerobic component of the exercise sessions will increase in duration from 35 to 50 minutes per session. Participants will walk on a treadmill at a speed and incline that corresponds to 70-80% of ventilatory threshold.

Postprandial Exercise

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify 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. Insulin delivery can be managed using either manual open-loop system (non-AID) or a hybrid closed loop (AID) systems.
• 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
• cm for males of European, Sub-Saharan African, Eastern Mediterranean and Middle Eastern descent
• cm for males of South Asian, Chinese, Japanese, South and Central American descent
• cm 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 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.
• Use a CGM in routine diabetes management.

You may not qualify 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 retinopathy, etc.) or other type of limitations (e.g., orthopedic, severe arthritis, etc.).
• 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).

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Diabetes Institute: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity; Fatty Liver

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Liver Diseases; Digestive System Diseases

Study Officials

• Normand G Boule, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Normand Boule, PhD

CONTACT

780-492-4695; nboule@ualberta.ca

Reid McClure, MSc

CONTACT

780-492-8079; rmcclur1@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre vs post, 2 group parallel study design

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: December 27, 2024
• Study Start: January 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will become available one year after the completion of the trial.
• Access Criteria: The outcome data will be open access through the University of Alberta "Education and Research Archive" (ERA) website. Other participant characteristics will be available as meta-data.

Locations

CA (1)