Healthy Outcomes for Muscle with Exercise in T1D

NCT05740514 | Recruiting

• 1 other identifier: 15516
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

Over 300,000 people in Canada suffer from Type 1 Diabetes (T1D), a chronic condition whose incidence rate has been increasing in Canada every year by 5.1% (higher than the global average). While exogenous insulin injections allow those with T1D to live, it is not a cure, and those with T1D develop severe complications (kidney failure, cardiovascular disease). Strategies to regress the development of these complications, minimize healthcare system burden, and save the lives of Canadians are urgently needed. Undertaking regular exercise is an obvious strategy for those with T1D and has many well-established health benefits. Despite these benefits, adults with T1D exercise less frequently due to fear of severe hypoglycemia and a lack of knowledge of effective exercise strategies. Adding to this complexity, the investigators have recently shown that males and females elicit differential impairments in skeletal muscle metabolism in response to T1D. These differences may extend to the peripheral microvasculature and may lead to sexual dimorphism in the health benefits of exercise for those with T1D. Ultimately, developing a healthy muscle mass, including microvasculature, will help mitigate dysglycemic and dyslipidemic fluctuations and improve insulin sensitivity. The overarching purpose of this proposed study is to determine the impact of T1D on human skeletal muscle and its microvasculature over the lifespan in males and females, and its responses to exercise training and detraining.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• The effect of T1D on skeletal muscle health, quantified by physiological parameters (detailed in description)

  Individuals with T1D as well as their age, sex, and BMI-matched control counterparts will undergo various physiological assessments to evaluate their muscle health: strength/aerobic fitness testing, compartmental body composition assessment, blood analysis, glucose monitoring, muscle biopsy, motor neuron function evaluation, and assessments of muscle microvascular structure and function. All metrics will be compared between individuals with T1D and their non-T1D counterparts.

  At time of study start (baseline characteristics)

Secondary Outcomes (3)

• The effect of twelve weeks of exercise on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description)

  Twelve weeks following study initiation

• The acute effect of a detraining period on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description)

  Thirteen weeks following study initiation

• The effect of a detraining period on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description)

  Seventeen weeks following study initiation

Study Arms (3)

Twelve-week Exercise

EXPERIMENTAL

Study participants will participate in an exercise program consisting of aerobic and resistance exercise. This arm will last twelve weeks.

Behavioral: Exercise

One-week Detraining

EXPERIMENTAL

Study participants will undergo unilateral knee immobilization for a one-week period.

Behavioral: De-training

Four-week Re-training

EXPERIMENTAL

Study participants will once again participate in an exercise program consisting of aerobic and resistance exercise. This arm will last four weeks.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Exercise training.

Four-week Re-training; Twelve-week Exercise

De-training BEHAVIORAL

Exercise de-training via unilateral knee immobilization.

One-week Detraining

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18-30 or 45-65
• Sedentary or recreationally active, as defined by self-reported activity levels below the recommended 150-minute minimum of moderate-to-vigorous intensity physical activity per week

You may not qualify if:

• Chronic use of anti-inflammatory, glucocorticoid, or other pain-relief medication
• History of daily cannabis, tobacco, or nicotine use within six months of study initiation
• BMI \>30kg/m2
• Prediabetes
• Type 2 diabetes
• Health conditions that put the subject at risk to participate in exercise during this study
• Atypical or Grade 2b diabetic sensorimotor polyneuropathy
• More than one lifetime event of hospitalization for diabetic ketoacidosis

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

RECRUITING

Related Publications (1)

• Rebalka IA, Noguchi KS, Bulyovsky KR, Badour MI, Juracic ES, Barrett K, Brahmbhatt A, Al-Khazraji B, Punthakee Z, Perry CGR, Kumbhare DA, MacDonald MJ, Hawke TJ. Targeting skeletal muscle health with exercise in people with type 1 diabetes: A protocol for HOMET1D, a prospective observational trial with matched controls. PLoS One. 2024 May 22;19(5):e0303448. doi: 10.1371/journal.pone.0303448. eCollection 2024.

  PMID: 38776307 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Thomas J Hawke, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas J Hawke, PhD

CONTACT

905-525-9140; hawke@mcmaster.ca

Irena A Rebalka, PhD

CONTACT

905-525-9140; rebalka@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Study subjects will participate in a twelve-week exercise program. Following this time, a one-week detraining period will ensue. Following this detraining period, study subjects will re-engage in a four-week exercise program.

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 23, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting in May 2024
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent internal committee identified for this purpose.

Locations

CA (1)