Prevention of Heart Failure in Type 2 Diabetes by Exercise Intervention

NCT05023538 | Active Not Recruiting

• 1 other identifier: Version 1, 10/06/2021
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 2

Brief Summary

Global longitudinal strain emerged as an important predictive marker that could be assessed during echocardiography. It enabled the detection of subclinical myocardial systolic dysfunction, without observable reductions in cardiac output or left ventricular ejection fraction, often years before diabetes induced heart failure. In asymptomatic T2D patients with no history of cardiovascular disease, an impaired global longitudinal strain is a predictor of future adverse left ventricular remodeling and adverse cardiovascular events. Exercise training is a promising intervention to interfere in the diabetes induced heart failure pathophysiology. However, the impact of different exercise modalities (e.g. intensity and volume) on the global longitudinal strain in type 2 diabetes (T2D) is unknown.

Conditions

Type 2 Diabetes

Keywords

T2D; exercise; rehabilitation; training; global longitudinal strain; echocardiography; heart; cardiac remodelling

Outcome Measures

Primary Outcomes (2)

• mPAP/CO and mPAP/CO slope

  * Mean pulmonary artery pressure by cardiac output and by cardiac output slope * mPAP/CO slope will be calculated via measurement of LVOTdiameter, LVOT VTI and sPAP at three timepoints during exercise echocardiography. These timepoints are: rest, low intense exercise (HR\<100 before fusion of early and late mitral inflow (E \& A)), and high-intense exercise (RER 1.02-1.05).

  at baseline and 6 months

• Global longitudinal strain (%)

  Cardiac function evaluation by echocardiography at rest

  at baseline and 6 months

Secondary Outcomes (5)

• Fasted Blood draw

  baseline, 3m and 6m

• Cardiopulmonary exercise testing on a bicycle

  baseline, 3m and 6m

• Rest and exercise echocardiography

  baseline and 6m

• Physical activity via Actigraph wGT3X-BT

  baseline, 3 and 6 months

• Body composition (%fat) via bioelectrical impedance

  baseline, 3 and 6m

Other Outcomes (2)

• Questionnaires (PA and SB, diet, quality of life)

  baseline and 6m

• flow mediated dilation, blood flow and HB content

  baseline and 6m

Study Arms (4)

Usual care

NO INTERVENTION

No intervention

Low-volume moderately-intense exercise

EXPERIMENTAL

exercise at 50-65%VO2peak; 20-30min/training session, 3x/week, 6 months

Other: Cycling

High-volume moderately-intense exercise

EXPERIMENTAL

exercise at 50-65%VO2peak; 20-50min/training session, 3x/week, 6 months

Other: Cycling

Low-volume high-intense exercise

EXPERIMENTAL

exercise at 50-85%VO2peak; 20-30min/training session, 3x/week, 6 months

Other: Cycling

Interventions

Cycling OTHER

Exercise on bicycle ergometer

High-volume moderately-intense exercise; Low-volume high-intense exercise; Low-volume moderately-intense exercise

Eligibility Criteria

• Age: 30 Years - 75 Years
• Gender Eligibility Details: 1:1 men/women distribution
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• physically inactive (no participation in structured or unstructured physical activity (PA) and not reaching the recommended PA guidelines: initially based on the International Physical Activity Questionnaire )
• age between 30-75 years
• blood HbA1c of 6-10% (if taking blood glucose lowering medication) or 6.5-10% without taking blood glucose lowering medication, and/or two-hour plasma glucose ≥11.1 mmol/L or ≥200 mg/dL following a 75g oral glucose load during OGTT.
• women of child bearing age will be included into the trial.

You may not qualify if:

• exogenous insulin therapy
• individuals suffering from any disease with significant impact on exercise intervention participation, such as: chronic heart disease or significant arrhythmias, cardiac events (myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention), chronic obstructive pulmonary, cerebrovascular or peripheral vascular disease, severe hypertension (\>160/110 mmHg), cancer, severe neuropathy (limiting exercise participation).

Sponsors & Collaborators

• Hasselt University: lead
• Jessa Hospital: collaborator
• KU Leuven: collaborator
• University Ghent: collaborator

Study Sites (2)

Faculty of Rehabilitation Sciences and Physiotherapy, Hasselt University

Hasselt, Belgium, 3590, Belgium

Location

Faculty of Movement and Rehabilitation Sciences

Leuven, Belgium, 3000, Belgium

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Researchers performing the outcome assessments and analyses will be blinded to treatment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single-blind randomized controlled trial and a cohort study.

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: August 26, 2021
• Study Start: March 1, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)