Fasted Exercise Training in Type 2 Diabetes

NCT03908281 | Completed

• 1 other identifier: Pro00088195
• 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 2 diabetes. Training will take place over 16 weeks.

Conditions

Diabetes Mellitus, Type 2

Keywords

Exercise; Glycated hemoglobin; Liver fat; Continuous glucose monitoring

Outcome Measures

Primary Outcomes (2)

• Concentration of HbA1c (mmol/mol)

  Glycated Hemoglobin

  Change from baseline HbA1c at 16 weeks

• Liver fat (%)

  Intra-hepatic fat measured by Magnetic Resonance Imaging

  Change from baseline liver fat at 16 weeks

Secondary Outcomes (12)

• Pancreatic fat (%)

  Change from pancreatic fat at 16 weeks

• Muscle fat (%)

  Change from baseline muscle fat at 16 weeks

• Concentrations of Fasting glucose

  Change from baseline fasting glucose at 16 weeks

• Concentrations of Fasting insulin

  Change from baseline fasting insulin at 16 weeks

• Concentrations of Fasting lipids

  Change from baseline fasting lipids at 16 weeks

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

Exercise training will take place 3 times per week and will progress to 60 minutes at a workload corresponding to 80% of Ventilatory Threshold.

Fasted Exercise

Postprandial Exercise BEHAVIORAL

Exercise training will take place 3 times per week and will progress to 60 minutes at a workload corresponding to 80% of Ventilatory Threshold.

Postprandial Exercise

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician diagnosed type 2 diabetes
• Treated with diet and/or glucose lowering medications, but not insulin, for at least 6 months
• Sedentary (defined as reaching \<150 minutes of aerobic exercise per week)
• A1C below 9.0%
• BMI ≥25 kg/m2
• Central obesity as determined by waist circumference according to Diabetes Canada cutoffs:
• greater or equal to 94cm for males of European, Sub-Saharan African, Eastern Mediterranean and Middle Eastern descent,
• greater or equal to 90cm for males of South Asian, Chinese, Japanese, South and Central American descent,
• greater or equal to 80cm for females
• Able to walk for 50 minutes

You may not qualify if:

• Smoking
• Consuming more than 10 alcoholic drinks/week
• History of stroke, myocardial infarction, or coronary artery disease
• Resting heart rate \<100 bpm
• Resting blood pressure \<160/100 mmHg
• Implantable device, such as a pacemaker, that would not be safe for Magnetic Resonance Imaging

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

Related Publications (1)

• Rees JL, Walesiak D, Thompson R, Mager D, Senior P, Boule NG. HbA1c and Liver Fat After 16 Weeks of Fasted versus Fed Exercise Training in Adults With Type 2 Diabetes. Med Sci Sports Exerc. 2025 Jan 1;57(1):106-114. doi: 10.1249/MSS.0000000000003552. Epub 2024 Sep 16.

  PMID: 39283231 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity; Fatty Liver

Condition Hierarchy (Ancestors)

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

Study Officials

• Normand Boulé, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: For most outcomes, including the primary outcome, the outcome assessor will be unaware of group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 9, 2019
• Study Start: September 1, 2019
• Primary Completion: July 11, 2022
• Study Completion: October 31, 2022
• Last Updated: December 1, 2022

Record last verified: 2022-11

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)