Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001295336p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
22/09/2026
Date registered
Help: Date registered
28/10/2026
Date last updated
Help: Date last updated
28/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
28/10/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
In people with type 2 diabetes (T2D) and metabolic dysfunction-associated steatotic liver disease (MASLD), does exercise training improve liver fibro-inflammation?
Scientific title
In people with type 2 diabetes (T2D) and metabolic dysfunction-associated steatotic liver disease (MASLD), does exercise training improve liver fibro-inflammation?
Additional trial identifiers [1] 318480 0
Nil
Universal Trial Number (UTN)
Trial acronym
EXCEL-FIT
Related trial records

Health condition
Health condition(s) studied:
Type 2 Diabetes 343656 0
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) 343657 0
Condition category
Condition code
Metabolic and Endocrine 339767 339767 0 0
Diabetes
Metabolic and Endocrine 339768 339768 0 0
Metabolic disorders
Oral and Gastrointestinal 339985 339985 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
What is the intervention:
12 weeks of supervised exercise training followed by 12 weeks of self-directed exercise training supported by one or more adherence building strategies.

Supervised Phase (12 wks)- Three supervised sessions/week with an exercise professional including (i) two session of high intensity interval training (HIIT) [4 x 4 mins high intensity exercise intervals (85-95% heart rate maximum, HRmax) interspersed with 3 min recovery intervals (50-60% HRmax)] total session duration 35 min (5 min warm up and cool down), and (ii) one session of moderate-intensity continuous training (MICT) (30 min at 55-65% HRmax) and progressive resistance training (30 min, 8-10 exercises, at moderate-vigorous intensity (~85% 1-RM); total session duration 60min. Participants will be asked to maintain their usual habitual physical activity levels. Participants will be provided with an exercise band and be instructed to complete an additional home-based resistance training session each week, which will be recorded using an exercise log.

Self-directed Phase (12 wks)- Following the post-supervised phase assessments, participants will be prescribed individually tailored self-directed exercise programs based on an equivalent type, duration and intensity to that in the supervised phase during an individual 60-minute health coaching session with a study investigator. In this session, participants will set SMART goals, undertake action planning and problem solving (encompassing barrier identification) and be provided with health information (including a flyer for the Heart Foundation walking program, an exercise band and diet information). At this time, participants will choose whether to participate in none, one or both adherence building strategies (described below). Participants will be recommended to attend at least one exercise ‘check-in and advice’ session and at least one exercise ‘booster’ session.

- Exercise 'check in and advice'- 45-60 minutes; scheduled fortnightly and will include both multidisciplinary health professional-led topics (e.g., ‘moving more and sitting less’ based on the 24-hour physical activity heat map; exercise adjustments/progressions) and group-led (e.g., sharing ideas for maintaining exercise; problem solving). These are aimed to be group sessions (up to 8 people at a time) however will still run if there is only one individual attending.

- Exercise 'booster' sessions- 45–60-minute exercise sessions will be conducted fortnightly (alternating with the exercise check-in and advice sessions, either individually or in groups of up to 5 people).


Who delivers it and their relevant expertise:
Sessions will be delivered by appropriately qualified exercise professional (a clinical exercise physiologist).

How it is delivered:
A suite of exercise session days and times will be available but will be capped at a maximum of three people per time to ensure adequate supervision and monitoring.

Where it is delivered:
Supervised training session will be conducted at The University of Queensland. Self-directed exercise will be delivered at the discretion of the participation (e.g., may be at home, or at a local exercise facility).

Adherence:
All supervised exercise sessions will be recorded. Self-directed exercise will be logged via an exercise diary and recorded at relevant online check-ins and/or booster sessions.
Intervention code [1] 335381 0
Treatment: Other
Intervention code [2] 335382 0
Lifestyle
Description of the comparator or control
What is the comparator:
The control group will undertake sham-exercise (stretching) 3 days/week for 12 weeks, with one supervised in-person session/week and two home-based sessions (involving the same stretching program as in the supervised session). This is designed to control for participation in supervised exercise without impact on liver-related or cardiometabolic outcomes. Following the 12-week assessments, participants in control will receive health information (including a flyer for the Heart Foundation walking program, physical activity heat map, an exercise band and diet information) only. Participants will have all study outcomes reassessed at 26 weeks. During the 12-week follow up, participants will be asked to continue the stretching routine; and be encouraged to utilise the heart foundation program resources which include walking and resistance band exercises. This is designed to emulate 'real world' advice.

Who delivers it and their relevant expertise:
Sessions will be delivered by appropriately qualified exercise professional (a clinical exercise physiologist).

How it is delivered:
A suite of exercise session days and times will be available but will be capped at a maximum of three people per time to ensure adequate supervision and monitoring.

Where it is delivered:
The supervised session will be delivered at The University of Queensland. The 'home-based' sessions will be conducted at home or in the participants workplace, at their choice.

Adherence:
All supervised exercise sessions will be recorded. Self-directed exercise will be logged via an exercise diary and recorded at relevant online check-ins and/or booster sessions.
Control group
Placebo

Outcomes
Primary outcome [1] 346936 0
Hepatic fibro-inflammation
Timepoint [1] 346936 0
Baseline, Week 12 (primary timepoint), Week 24, 12 month post-baseline follow-up.
Secondary outcome [1] 468182 0
Proportion of participants classified as responders on their individually selected priority patient-reported outcome (one of fatigue, pain interference, quality of life or exercise self-efficacy), rated weekly using a visual analogue scale (VAS). This is a secondary, hypothesis-generating outcome.
Timepoint [1] 468182 0
Weekly from baseline to week 12 and week 13-24. Responder status will be determined at 12, 24 and 12 month post-baseline assessment follow up.
Secondary outcome [2] 468218 0
Health-related Quality of Life
Timepoint [2] 468218 0
Baseline, Week 12, Week 24, 12 month post-baseline follow up
Secondary outcome [3] 468220 0
Exercise-related self-efficacy
Timepoint [3] 468220 0
Baseline, week 12, week 24, 12 month post-baseline follow-up
Secondary outcome [4] 468221 0
Pain interference (from body pain)
Timepoint [4] 468221 0
Baseline, week 12, week 24, 12 month post-baseline follow-up
Secondary outcome [5] 468222 0
Fatigue
Timepoint [5] 468222 0
Baseline, week 12, week 24, 12 month post-baseline follow-up
Secondary outcome [6] 468223 0
MRI-derived body composition
Timepoint [6] 468223 0
Baseline, week 12, week 24, 12 month post-baseline follow-up
Secondary outcome [7] 468229 0
Intra-hepatic lipid
Timepoint [7] 468229 0
Baseline, week 12, week 24, 12 month post-baseline follow-up
Secondary outcome [8] 468236 0
Changes in body composition measured by dual-energy x-ray absorptiometry
Timepoint [8] 468236 0
Baseline, week 12, week 24, 12 month post-baseline follow-up
Secondary outcome [9] 468244 0
Changes in body composition measure by peripheral quantitative computed tomography
Timepoint [9] 468244 0
Baseline, week 12, week 24, 12 month post-baseline follow-up
Secondary outcome [10] 468245 0
Liver stiffness measure
Timepoint [10] 468245 0
Baseline, 12 weeks, 24 weeks, 12 month post-baseline follow-up
Secondary outcome [11] 468246 0
Controlled attenuation parameter to indicate hepatic steatosis
Timepoint [11] 468246 0
Baseline, 12 weeks, 24 weeks, 12 month post-baseline follow-up
Secondary outcome [12] 468247 0
Changes in measures of cardiac function from magnetic resonance imaging
Timepoint [12] 468247 0
Baseline, 12 weeks, 24 weeks, 12 month post-baseline follow-up
Secondary outcome [13] 468255 0
Change in measures of cardiorespiratory fitness/exercise capacity
Timepoint [13] 468255 0
Baseline, 12 weeks, 24 weeks, 12 month post-baseline follow-up
Secondary outcome [14] 468260 0
Muscle strength
Timepoint [14] 468260 0
Baseline, 12 weeks, 24 weeks, 12 month post-baseline follow-up
Secondary outcome [15] 468263 0
Resting Energy Expenditure
Timepoint [15] 468263 0
Baseline, week 12, week 24, 12 month post-baseline follow-up
Secondary outcome [16] 468265 0
Feasibility
Timepoint [16] 468265 0
Week 12 post-baseline (following supervised intervention) and week 24 post-baseline (following the self-directed intervention).
Secondary outcome [17] 468266 0
24-hour integrated movement behaviour
Timepoint [17] 468266 0
Baseline, week 12, week 24 and 12-month post-baseline follow up
Secondary outcome [18] 468267 0
Participant perspectives and experiences of physical activity (composite)
Timepoint [18] 468267 0
Baseline, week 12, week 24 and 12 month post-baseline follow up. Survey at week 24 only
Secondary outcome [19] 468268 0
Dietary behaviour
Timepoint [19] 468268 0
Baseline, week 12, week 24, 12 month post-baseline follow up
Secondary outcome [20] 468389 0
Muscle function
Timepoint [20] 468389 0
Baseline, week 12, week 24, 12 month post-baseline follow up
Secondary outcome [21] 469143 0
Health-related quality of life
Timepoint [21] 469143 0
Baseline, week 12, week 24, 12 month post-baseline follow-up
Secondary outcome [22] 469144 0
Hand Grip Strength
Timepoint [22] 469144 0
Baseline, week 12, week 24, 12 month post-baseline follow up
Secondary outcome [23] 469145 0
Mediterranean diet score
Timepoint [23] 469145 0
Baseline, week 12, week 24, 12 months post-baseline follow-up
Secondary outcome [24] 469146 0
Food timing
Timepoint [24] 469146 0
Baseline, week 12, week 24, 12 months post-baseline follow-up
Secondary outcome [25] 469147 0
Arterial Stiffness
Timepoint [25] 469147 0
Baseline, week 12, week 24, 12 month post-baseline follow-up
Secondary outcome [26] 469148 0
Central blood pressures
Timepoint [26] 469148 0
Baseline, week 12, week 24, 12 month post-baseline follow-up
Secondary outcome [27] 469149 0
Body weight
Timepoint [27] 469149 0
Baseline, week 12, week 24, 12-month post-baseline follow-up
Secondary outcome [28] 469150 0
Height
Timepoint [28] 469150 0
Baseline, week 12, week 24, 12-month post-baseline follow-up
Secondary outcome [29] 469151 0
Body Mass Index
Timepoint [29] 469151 0
Baseline, week 12, week 24, 12-month post-baseline follow-up
Secondary outcome [30] 469152 0
Waist circumference
Timepoint [30] 469152 0
Baseline, week 12, week 24, 12-month post-baseline follow-up
Secondary outcome [31] 469154 0
Hip circumference
Timepoint [31] 469154 0
Baseline, week 12, week 24, 12-month post-baseline follow-up
Secondary outcome [32] 469156 0
Waist:height ratio
Timepoint [32] 469156 0
Baseline, week 12, week 24, 12-month post-baseline follow-up
Secondary outcome [33] 469158 0
Glycated Haemoglobin (HbA1c)
Timepoint [33] 469158 0
Baseline, week 12, week 24, 12-month post-baseline follow-up
Secondary outcome [34] 469164 0
Total cholesterol
Timepoint [34] 469164 0
Baseline, week 12, week 24, 12-month post-baseline follow-up
Secondary outcome [35] 469166 0
Low-density lipoprotein cholesterol
Timepoint [35] 469166 0
Baseline, week 12, week 24, 12-month post-baseline follow-up
Secondary outcome [36] 469167 0
high-density lipoprotein cholesterol
Timepoint [36] 469167 0
Baseline, week 12, week 24, 12-month post-baseline follow-up
Secondary outcome [37] 469170 0
Liver aminotransferases
Timepoint [37] 469170 0
Baseline, week 12, week 24, 12-month post-baseline follow-up
Secondary outcome [38] 469171 0
Fasting plasma glucose
Timepoint [38] 469171 0
Baseline, week 12, week 24, 12-month post-baseline follow-up
Secondary outcome [39] 469172 0
Blood platelets
Timepoint [39] 469172 0
Baseline, week 12, week 24, 12-month post-baseline follow-up
Secondary outcome [40] 469173 0
Blood biomarkers for liver disease, and inflammation: The following secondary outcomes will be assessed separately: albumin, Fibrosis 4 Index, Enhanced Liver Fibrosis test (ELF), inflammasome
Timepoint [40] 469173 0
Baseline, week 12, week 24, 12-month post-baseline follow up

Eligibility
Key inclusion criteria
Adults (18-70y) living in Brisbane diagnosed by a medical professional with type 2 diabetes (glycated haemoglobin [HbA1c] greater than or equal to 7.0%), with central adiposity (waist circumference greater than or equal to 94 cm for men; greater than or equal to 80 cm for women, or ethnic-specific waist circumference cut-offs indicating elevated cardiometabolic disease risk), and low physical activity (not meeting current physical activity guidelines [<150minutes per week of moderate intensity aerobic activity or vigorous intensity equivalent]). MASLD status will be confirmed at baseline assessment if not already indicated (e.g., controlled attenuation parameter of greater than or equal to 264 dB/m via vibration-controlled transient elastography, or confirmed by biopsy or imaging in previous 6mths, or elevated liver aminotransferases).
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Any medical condition in which exercise is contraindicated (per established criteria of the American College of Sports Medicine), liver disease other than MASLD, currently meeting physical activity guidelines (150 weighted min/week moderate-vigorous activity), recent (<3mth) change in medication or body weight, non-Medicare eligible, or contraindication to magnetic resonance imaging.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using a web-based process (Sealed envelope.com) concealing the randomisation procedure. Where possible, project staff conducting the assessments will be blinded to participants’ allocation. Participants will be randomised in 1:1 ratio into exercise or stretch control, stratified by age (<50 or 50 + years) and sex. A researcher not associated with the study will complete randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:
This study was designed to detect the smallest effect size of interest between exercise and control for hepatic cT1 score at 12-week follow-up, assuming an a of 0.05 (two-sided), 90% power, and adjustment for test-retest reliability by incorporating the reliability coefficient p (["participants needed for a t-test" ]×[1-p^2]).
To detect a between-group net difference of d=0.199 based on a clinically meaningful mean difference of 80 ms, SD of 402 ms, and p of 0.97, 42 total patients are required (n=21 per group). To account for a conservative attrition rate of 15% (despite an attrition rate of <15% in our prior trials), 50 (rounded from 49.6) total patients (n=25 per group) will be recruited. Our power calculation (t tests, means: difference between two independent means [two groups]) was conducted in G*Power (v3.1.9.7).
For self-selected patient important outcome, the proportion of responders will be compared between groups using logistic regression adjusted for baseline score, or contingency table approaches where appropriate

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/11/2026
Actual
Date of last participant enrolment
Anticipated
31/07/2028
Actual
Date of last data collection
Anticipated
31/01/2030
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 323056 0
Government body
Name [1] 323056 0
National Health and Medical Research Council
Country [1] 323056 0
Australia
Funding source category [2] 323067 0
University
Name [2] 323067 0
The University of Queensland UQ Foundation Research Excellence Award
Country [2] 323067 0
Australia
Funding source category [3] 323068 0
Commercial sector/Industry
Name [3] 323068 0
Perspectum
Country [3] 323068 0
United Kingdom
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 326011 0
None
Name [1] 326011 0
Address [1] 326011 0
Country [1] 326011 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 321458 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 321458 0
Ethics committee country [1] 321458 0
Australia
Date submitted for ethics approval [1] 321458 0
16/09/2026
Approval date [1] 321458 0
Ethics approval number [1] 321458 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 153790 0
A/Prof Shelley Keating
Address 153790 0
The University of Queensland, Blair Drive, School of Human Movement and Nutrition Sciences, St Lucia 4072, Queensland
Country 153790 0
Australia
Phone 153790 0
+61 7 334 69999
Fax 153790 0
Email 153790 0
[email protected]
Contact person for public queries
Name 153791 0
Shelley Keating
Address 153791 0
The University of Queensland, Blair Drive, School of Human Movement and Nutrition Sciences, St Lucia 4072, Queensland
Country 153791 0
Australia
Phone 153791 0
+61 7 334 69999
Fax 153791 0
Email 153791 0
[email protected]
Contact person for scientific queries
Name 153792 0
Shelley Keating
Address 153792 0
The University of Queensland, Blair Drive, School of Human Movement and Nutrition Sciences, St Lucia 4072, Queensland
Country 153792 0
Australia
Phone 153792 0
+61 7 334 69999
Fax 153792 0
Email 153792 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Statistical analysis plan    Data Anlaysis EXCEL FIT 22.09.26.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.