Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000552381
Ethics application status
Approved
Date submitted
6/04/2017
Date registered
20/04/2017
Date last updated
23/11/2021
Date data sharing statement initially provided
12/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of Exercise Intervention on the Phenome (Metabolism and Predictive Complications) in Well Characterised Pre-diabetes and New Onset Type 2 diabetes Cohorts in China and Australia.
Scientific title
Impact of Exercise Intervention on the Phenome (Metabolism and Predictive Complications) in Well Characterised Pre-diabetes and New Onset Type 2 diabetes Cohorts in China and Australia.
Secondary ID [1] 291557 0
NHMRC - APP1113612
Secondary ID [2] 291561 0
NSFC - 81222008
Universal Trial Number (UTN)
U1111-1194-7933
Trial acronym
PACE-G
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-alcoholic fatty liver disease 302678 0
Type 2 Diabetes Mellitus 302679 0
Pre-diabetes 302680 0
Condition category
Condition code
Oral and Gastrointestinal 302193 302193 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 302308 302308 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
540 individuals in total will be recruited. This cohort will be recruited in three glucose profile groups (newly diagnosed diabetic, pre-diabetic, normal glucose) of 180 individuals each, split evenly between Australian and Chinese sites such that 90 individuals of each glucose group is recruited in each country. Each glucose group in each country will be randomised in a 1:1 ratio between intervention and control. All participants randomised to the initial intervention treatment, and participants from the diabetic and pre-diabetic glucose groups from the initial control treatment will be followed up for the full duration of 2 years. Participants from the normal glucose group who are randomised to the initial control treatment will not be followed up after 12 weeks.

Initial intervention:
3 exercise sessions per week, 2 sessions supervised in person by an Exercise Physiologist, consisting of High Intensity Interval Training (HIIT) at 85-95% Maximum Heart Rate (HRmax) for approximately 15 minutes including warm up and cool down, using a treadmill, cycle ergometer, or land based walking as appropriate, and Progressive Resistance Training (PRT) at 60-80% of 1 Repetition Maximum (1RM) using 8 resistance exercises of various major muscle groups, and 1 session of HIIT unsupervised per week, all for 12 weeks. The supervised sessions will be prescribed and delivered individually, either in an individual setting or in a group of up to three, as circumstances dictate. Compliance with this intervention will be measured by a record of sessions attended, which will be kept by trial staff, in conjunction with an exercise diary issued by the trial and kept by the participant for all unsupervised exercise sessions.

After 12 weeks of the initial intervention/control treatment all participants who were randomised to the HIIT intervention will be re-randomised to either a follow up intervention (increased support group) or a follow up control treatment (text message support program group) and instructed to continue exercising independently.

Follow-up intervention:
An increased support group continuing until the 12 month follow up: Participants will be given a “Fitbit” physical activity monitoring device at week 12 of the exercise program and instructed to wear it every day. They will be taught how to use the Fitbit to ensure they reach 85-95% of their HR max for their HIIT sessions.
Participants will be instructed to upload their data to an online database through which the researchers will track participants’ progress including heart rate data, estimated energy expenditure, body weight and exercise episodes. If participants are not meeting the targets for the HIIT exercise sessions they will be contacted using the escalating methods of email, text message or phone calls.
The triggers for contact will be:
1. If a participant has not worn their Fitbit for two consecutive weeks an email will be sent. If there is no contact within a week, a text message will be sent. If there is still no contact within another week, the participant will be contacted by phone to discuss possible barriers to adherence and methods to enhance the process.
2. If the participant has worn the FitBit but has not achieved the prescribed HR for HIIT for at least one session per week, they will be sent an email after one week, a text message after two weeks, and called by phone after three weeks.
3. If a participant demonstrates compliance with their HIIT sessions, a positive feedback text message will be sent on a monthly basis to encourage them to continue.
4. If a participant demonstrates repeated non-compliance with the HIIT sessions, they will be invited to come back for a supervised session with the Exercise Physiologist to address any problems.

Analysis of results will compare initial intervention groups against each other, maintenance intervention groups against each other, and Australian and Chinese cohorts against each other.
Intervention code [1] 297638 0
Lifestyle
Intervention code [2] 297745 0
Treatment: Other
Comparator / control treatment
Initial control:
Flexibility training on 1 occasion supervised by an Exercise Physiologists, followed by flexibility training without supervision on 3 occasions per week for 12 weeks.

Follow-up control:
A text message support program: This group will be sent pre-defined motivational text messages at weekly intervals to encourage adherence to the prescribed exercise program. No additional equipment will be given.
Control group
Placebo

Outcomes
Primary outcome [1] 301613 0
The mean difference of the change in liver steatosis quantified by 1H-MRS (as a percentage) between the exercise and control groups.
Timepoint [1] 301613 0
12 Weeks after intervention commencement.
Secondary outcome [1] 333296 0
Differences in relative insulin deficiency profiles (by HOMA) between blood glucose profiles and between Australian and Chinese cohorts.
Timepoint [1] 333296 0
At Baseline
Secondary outcome [2] 333297 0
Differences in metabolic syndrome profiles (by IDF criteria) between blood glucose profiles and between Australian and Chinese cohorts.
Timepoint [2] 333297 0
At Baseline
Secondary outcome [3] 333298 0
Mean difference in urine albumin/creatinine ratio between glucose profiles and between Australian and Chinese cohorts.
Timepoint [3] 333298 0
At Baseline
Secondary outcome [4] 333299 0
Mean difference in diabetic retinopathy, as assessed by retinal photography according to the ETDRS scale, between glucose profiles and between Australian and Chinese cohorts,
Timepoint [4] 333299 0
At Baseline
Secondary outcome [5] 333302 0
Mean difference in liver fat percentage including NAFLD, and change therein, as assessed by Fibroscan, between glucose profiles, between Australian and Chinese cohorts, and between the text reminder and increased support groups.
Timepoint [5] 333302 0
At Baseline, and at 12 Weeks, 12 Months, and 24 Months after initial intervention commencement.
Secondary outcome [6] 333304 0
Mean difference in surrogate imaging of liver inflammation/fibrosis (as assessed by T1 mapping and Fibroscan) between glucose profiles and between Australian and Chinese cohorts.
Timepoint [6] 333304 0
At Baseline
Secondary outcome [7] 333307 0
Mean difference, and mean difference of change, in cardiac autonomic neuropathy (as assessed by measurement heart rate responses to valsalva, ECG R-R interval response to deep breathing, and immediate heart rate response to standing from recumbency) between glucose profiles, between the exercise and control groups, between Australian and Chinese cohorts, and between the text reminder and increased support groups.
Timepoint [7] 333307 0
At Baseline, and 12 Weeks, 12 Months, and 24 Months after initial intervention commencement.
Secondary outcome [8] 333308 0
Mean difference in history of macrovascular disease, as assessed by Ankle-Brachial Index and medical history review, between glucose profiles and between Australian and Chinese cohorts.
Timepoint [8] 333308 0
At Baseline.
Secondary outcome [9] 333309 0
Mean difference, and mean difference of change, in vascular dysfunction as measured by tonometry between glucose profiles, between the exercise and control groups, between Australian and Chinese cohorts, and between the text reminder and increased support groups.
Timepoint [9] 333309 0
At Baseline, and 12 Weeks, 12 Months, and 24 Months after initial intervention commencement.
Secondary outcome [10] 333312 0
Mean difference in cognitive scores as assessed by CANTAB questionnaires between glucose profiles and between Australian and Chinese cohorts, and mean difference in the change therein from baseline between exercise and control groups, and between the text reminder and increased support groups.
Timepoint [10] 333312 0
At Baseline, and 12 Weeks, 12 Months, and 24 Months after initial intervention commencement.
Secondary outcome [11] 333313 0
Utility of blood FAP, blood DPP4, blood CTGF, blood P3NP, blood MMP-9, blood TIMP-1. and blood hyaluronic acid for predicting NAFLD fibrosis as measured by Fibroscan, and for predicting NAFLD inflammation-fibrosis as inferred by MRI T1 mapping of the liver.
Timepoint [11] 333313 0
At Baseline
Secondary outcome [12] 333344 0
Relation of blood biomarkers (telomeres, FAP, DPP4, CTGF, key monocyte CD markers, and pro-inflammatory cytokines) to end-organ complications in diabetes (for applicable subjects).
Timepoint [12] 333344 0
At Baseline
Secondary outcome [13] 333345 0
Mean difference of the change in liver steatosis as determined by 1H-MRS between the exercise and control groups within individual glucose profile groups, and between the text reminder and increased support groups.
Timepoint [13] 333345 0
12 Weeks, 12 Months, and 24 Months after initial intervention commencement.
Secondary outcome [14] 333346 0
Mean difference of the change in albuminuria between the exercise and control groups, between Australian and Chinese cohorts, and between the text reminder and increased support groups.
Timepoint [14] 333346 0
12 Weeks, 12 Months, and 24 Months after initial intervention commencement.
Secondary outcome [15] 333348 0
Mean difference of the change in fasting plasma glucose between the exercise and control groups, and between the text reminder and increased support groups.
Timepoint [15] 333348 0
12 Weeks, 12 Months, and 24 Months after initial intervention commencement.
Secondary outcome [16] 333349 0
Mean difference of the change in blood C-peptide between the exercise and control groups, and between the text reminder and increased support groups.
Timepoint [16] 333349 0
12 Weeks, 12 Months, and 24 Months after initial intervention commencement.
Secondary outcome [17] 333351 0
Mean difference of the change in blood fructosamine between the exercise and control groups, and between the text reminder and increased support groups.
Timepoint [17] 333351 0
12 Weeks, 12 Months, and 24 Months after initial intervention commencement.
Secondary outcome [18] 333500 0
Mean difference of the change in insulin sensitivity, as calculated by Homeostatic Model Assessment (HOMA), between the exercise and control groups, and between the text reminder and increased support groups.
Timepoint [18] 333500 0
12 Weeks, 12 Months, and 24 Months after initial intervention commencement.
Secondary outcome [19] 333501 0
Mean difference of the change in glycated haemoglobin (HbA1c) between the exercise and control groups, and between the text reminder and increased support groups.
Timepoint [19] 333501 0
12 Weeks, 12 Months, and 24 Months after initial intervention commencement.
Secondary outcome [20] 333502 0
Mean difference of the change in blood lipid profiles between the exercise and control groups, and between the text reminder and increased support groups.
Timepoint [20] 333502 0
12 Weeks, 12 Months, and 24 Months after initial intervention commencement.
Secondary outcome [21] 333503 0
Mean difference of the change in Australian Quality of Life (AQoL) questionnaire scores between the exercise and control groups, and between the text reminder and increased support groups.
Timepoint [21] 333503 0
12 Weeks, 12 Months, and 24 Months after initial intervention commencement.
Secondary outcome [22] 333504 0
Mean difference of the change in Patient Health Questionnaire-9 (PHQ-9) scores between the exercise and control groups, and between the text reminder and increased support groups
Timepoint [22] 333504 0
12 Weeks, 12 Months, and 24 Months after initial intervention commencement.
Secondary outcome [23] 333505 0
Mean difference of the change in Self-efficacy for Exercise (SEE) questionnaire scores between the exercise and control groups, and between the text reminder and increased support groups.
Timepoint [23] 333505 0
12 Weeks, 12 Months, and 24 Months after initial intervention commencement.
Secondary outcome [24] 333507 0
Mean difference of the change in physical activity (including moderate-vigorous, low-intensity and sedentary time), as assessed by activPAL, between the exercise and control groups.
Timepoint [24] 333507 0
12 Weeks and 12 Months after intervention commencement.
Secondary outcome [25] 333508 0
Occurrence of adverse events (as per ICH-GCP definition: any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a treatment, without any judgment about causality or relationship to the treatment), by participant reporting, between the exercise and control groups. Exercise carries an increased risk of soft tissue injuries. No increased risk of cardiovascular events is not anticipated as high risk participants will be screen out according to the eligibility criteria.
Timepoint [25] 333508 0
12 Weeks and 12 Months after intervention commencement.
Secondary outcome [26] 333509 0
Body composition as measured by weight, DXA, MRI (visceral fat), and waist circumference, and changes therein, between glucose groups, between Australian and Chinese cohorts, and between the exercise and control groups.
Timepoint [26] 333509 0
Baseline, and 12 Weeks and 12 Months after intervention commencement.
Secondary outcome [27] 333510 0
Change in aerobic fitness, measured by Bruce Protocol graded exercise stress test.
Timepoint [27] 333510 0
12 Weeks after intervention commencement
Secondary outcome [28] 333511 0
Gut microbiota sub-study: change in overall gut microbiota profile.
Timepoint [28] 333511 0
12 Weeks after intervention commencement.
Secondary outcome [29] 333512 0
Gut microbiota sub-study: change in gut permeability as measured by blood zonulin.
Timepoint [29] 333512 0
12 Weeks after intervention commencement.
Secondary outcome [30] 333513 0
Gut microbiota sub-study: change in measured blood endotoxemia levels
Timepoint [30] 333513 0
12 Weeks after intervention commencement.
Secondary outcome [31] 333515 0
Gut microbiota sub-study: inflammatory changes as measured by faecal lipocalin 2.
Timepoint [31] 333515 0
12 Weeks after intervention commencement.
Secondary outcome [32] 333544 0
Gut microbiota sub-study: change in faecal bile acid profile.
Timepoint [32] 333544 0
12 Weeks after intervention commencement.
Secondary outcome [33] 333545 0
Incremental cost effectiveness ratio (ICER) of percentage liver fat reduction; and ICER of Quality-Adjusted-Life-Years (QALYs) gained within trial and estimated lifetime gains from a health services perspective.
Timepoint [33] 333545 0
12 Weeks and 12 Months after intervention commencement
Secondary outcome [34] 333727 0
The mean difference of the change in physical activity, including moderate-vigorous, low-intensity and sedentary time as measure by FitBit data between the text reminder and increased support groups.
Timepoint [34] 333727 0
12 months after initial intervention commencement.
Secondary outcome [35] 333728 0
Mean difference in number of home HIIT sessions undertaken per week as measured by FitBit data between the text reminder and increased support groups.
Timepoint [35] 333728 0
12 months after initial intervention commencement.
Secondary outcome [36] 333729 0
Average minutes of in peak zone, as measured by FitBit data between the text reminder and increased support groups.
Timepoint [36] 333729 0
12 months after initial intervention commencement.
Secondary outcome [37] 333730 0
Mean number of steps taken daily as measured by FitBit data between the text reminder and increased support groups.
Timepoint [37] 333730 0
12 months after initial intervention commencement.
Secondary outcome [38] 333731 0
Descriptive statistics of the following in the increased support group: The number of phone calls made to participants; the number of text messages sent to participants; the number of emails sent to participants; Type of association with contacts made and maintenance of exercise; adherence to wearing the FitBit.
Timepoint [38] 333731 0
12 months after initial intervention commencement.

Eligibility
Key inclusion criteria
- BMI greater than or equal to 25 kg/m2 (Non-Asian participants) or BMI greater than or equal to 23 kg/m2 (Asian participants)
- Willing to undertake, and have no contraindications to, exercise testing and a program involving high intensity interval training program, resistance training or stretching
- Willing to give written informed consent
- Adequate understanding of national language
- Access to either phone or internet (this is necessary when being contacted by the instructors throughout the duration of the trial)
- Maximum weight of 140kg (equivalent MRI habitus limit)
- No change in medication or dose for the previous three months

- 90 participants at each site will be recruited from each of three glucose groups as defined by any one of the ADA criteria. That is Type 2 Diabetes Mellitus - HbA1c greater than or equal to 6.5%, Fasting Plasma Glucose (FPG) greater than or equal to 7.0 mmol/L, 2h post-Oral Glucose Tolerance Test Plasma Glucose (2hOGTT) greater than or equal to 11.1 mmol/L; Pre-diabetes - one occasion of any of the following in a participants medical history: HBA1c greater than or equal to 5.7% but less than 6.5%, FPG greater than or equal to 5.6 mmol/L but less than 7.0 mmol/L, 2hOGTT greater than or equal to 7.8 mmol/L but less than 11.1 mmol/L; Normal Glucose Profile - HbA1c less than 5.7%; FPG less than 5.6%; 2hOGTT less than 5.6 mmol/L.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Untreated dense insensate peripheral neuropathy that contraindicates exercise testing and training (as assessed by medical assessment)
- Significant cardiovascular disease including current angina; myocardial infarction or stroke within the past 6 months; heart failure; symptomatic peripheral vascular disease
- Active foot ulcer
- Musculoskeletal condition affecting ability to undertake exercise testing and training
- Self-reported average weekly intake of alcohol >140g per week
- Abnormalities noted by medical officer based on the resting ECG suggestive of unrecognised myocardial ischaemia: q waves, or ST wave depression.
- Self-reported currently completing >75 min/week high intensity exercise or >150 min/week moderate intensity exercise.
- Pregnancy, lactation or plans to become pregnant in the next 2 years.
- Claustrophobia or ferrous metal implants/devices which contraindicate MRI scan.
- Thiazolidinedione medication
- History of Hepatitis B or C which has not been cured
- Advanced chronic renal impairment (CKD state 4 or 5 or EFGR< 30)
- Cirrhosis
- Malignancy which is currently active or in remission for less than five years after last treatment (local basal and squamous cell skin cancer allowed)
- Blood donation or transfusion within the past month
- Haemoglobin concentration below local laboratory reference values (i.e. anaemia).
- Alanine Transaminase (ALT) and/or Apartate Transaminase (AST) >3 times the Upper Limit of Normal (local laboratory reference values)
- Any other condition deemed by the study physician that would prevent participation in the trial.
- Weight change of greater than or equal to 5% in the past three months.

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 by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The glucose groups will be combined for the primary outcome analyses examining the differences in the change of liver steatosis between intervention and the control groups. As the percentage of participants that has liver steatosis, defined as at least 5% of the liver being composed of lipid, will likely differ based on glucose group and effects of exercise may differ within groups, we plan to investigate the change in liver steatosis within glucose groups as well as combined.

Previous research that has shown high intensity exercise can reduce liver fat by 2.62% (SE 1.0%) and the mean difference between placebo and exercise groups was approximately 3.6 %. Participants in this study were overweight or obese and therefore likely to have less percentage liver fat than those with prediabetes and diabetes (and overweight/obese). The study has been therefore powered to show a 3% mean difference between the intervention and control groups for each glucose group due to the variance by glucose group.

By power calculation, 90 participants per glucose category of pre-diabetes, recent onset type 2 diabetes and normal glucose groups, will give power of 90% to show at least a 3% mean difference in liver fat by NMR spectroscopy measures with a standard deviation of 4% as found in our previous studies and taking into account a dropout rate of 15% at 12 weeks. Thus 270 participants will be recruited at the Australian site for analysis of the primary endpoint. 270 participants will also be recruited at the Chinese site for simultaneous analysis of the primary endpoint at their site, with data from their cohort.

In the pre-defined secondary end-points, Australian and Chinese cohort data will be compared.

For the sub study RCT there is a lack of research in this area and it is therefore quite difficult to know upon what data to base the power calculation. We hypothesize that those randomised to the support group will complete 30% more HIIT sessions than the text message group and the standard deviation could be approximately 20%. This would be measured by the self-reported diaries and we would also use the Active PAL to examine objectively measured physical activity. If we assume that there will be a further 15% drop out rate of 15% at 12 months this would mean 100 participants in the exercise arm would be followed up. This would give greater than 90% power to detect a difference of 30%, with a standard deviation of 20%.

The primary outcome will be assessed by analysis of covariance to compare percentage liver fat change (quantified by 1H-MRS) (baseline to 12 weeks) between the intervention and control group. Baseline liver fat percentage and glucose group will be included as covariates. All participants will be included in the primary analysis and missing data will be imputed by the multiple imputation method. A similar analysis will be used to compare the secondary outcomes of change in liver fat from baseline to 1 and 2-year follow-up. Other outcomes will be evaluated using generalised mixed modelling and will be dependent on the data.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Other reasons/comments
Other reasons
COVID-19 pandemic caused delays in recruitment which exhausted funding.
Date of first participant enrolment
Anticipated
1/05/2018
Actual
18/07/2018
Date of last participant enrolment
Anticipated
1/04/2021
Actual
12/05/2021
Date of last data collection
Anticipated
1/04/2023
Actual
Sample size
Target
270
Accrual to date
Final
162
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7771 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 15704 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 8776 0
China
State/province [1] 8776 0
Shanghai Municipality

Funding & Sponsors
Funding source category [1] 296047 0
Government body
Name [1] 296047 0
National Health and Medical Research Council
Country [1] 296047 0
Australia
Funding source category [2] 296099 0
Charities/Societies/Foundations
Name [2] 296099 0
Reginald Ward and Adrian Cotter Foundation, via the Endocrinology and Diabetes Research Fund, Sydney Medical School Foundation
Country [2] 296099 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
City Rd
Camperdown/Darlington NSW 2006
Country
Australia
Secondary sponsor category [1] 295000 0
None
Name [1] 295000 0
Address [1] 295000 0
Country [1] 295000 0
Other collaborator category [1] 279520 0
University
Name [1] 279520 0
Shanghai Jiao Tong University
Address [1] 279520 0
800 Dongchuan Rd
Minhang Qu, China, 200240
Country [1] 279520 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297303 0
Sydney Local Health District, Royal Prince Alfred Hospital
Ethics committee address [1] 297303 0
Ethics committee country [1] 297303 0
Australia
Date submitted for ethics approval [1] 297303 0
10/10/2016
Approval date [1] 297303 0
27/01/2017
Ethics approval number [1] 297303 0
HREC/16/RPAH/594

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

Contacts
Principal investigator
Name 73642 0
Prof Stephen Twigg
Address 73642 0
Kellion Professor of Endocrinology,
Stan Clark Chair in Diabetes,
Sydney Medical School,
The University of Sydney
Level 3W, Charles Perkins Centre - D17
The University of Sydney NSW 2006
Country 73642 0
Australia
Phone 73642 0
+61 2 8627 1890
Fax 73642 0
+61 2 8627 1604
Email 73642 0
[email protected]
Contact person for public queries
Name 73643 0
James Gerofi
Address 73643 0
The University of Sydney
Level 3W, Charles Perkins Centre - D17
The University of Sydney NSW 2006
Country 73643 0
Australia
Phone 73643 0
+61 2 8627 1927
Fax 73643 0
+61 2 8627 1604
Email 73643 0
[email protected]
Contact person for scientific queries
Name 73644 0
James Gerofi
Address 73644 0
The University of Sydney
Level 3W, Charles Perkins Centre - D17
The University of Sydney NSW 2006
Country 73644 0
Australia
Phone 73644 0
+61 2 8627 1927
Fax 73644 0
+61 2 8627 1604
Email 73644 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.