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Trial registered on ANZCTR


Registration number
ACTRN12611000709943
Ethics application status
Approved
Date submitted
8/07/2011
Date registered
8/07/2011
Date last updated
9/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Lung function at rest and during exercise in patients with newly-diagnosed early-onset type 2 diabetes mellitus: a pilot study
Scientific title
Lung function at rest and during exercise in patients with newly-diagnosed early-onset type 2 diabetes mellitus
Secondary ID [1] 262590 0
Nil
Universal Trial Number (UTN)
U1111-1122-7240
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
newly-diagnosed early-onset type 2 diabetes mellitus 268268 0
Condition category
Condition code
Metabolic and Endocrine 268402 268402 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Tests of lung and heart function at rest and during exercise. All of the tests below are conducted on the same day and are anticipated to take about 3.5 hours.

Tests conducted at rest:
1. Blood sampling. 20 mls of venous blood will be sampled from the antecubital fossa (near elbow crease) by inserting a small butterfly catheter. Note that you are required to fast overnight (and patients with T2D are also required to delay the morning diabetes medication). A light breakfast and diabetes medications will be taken as soon as blood has been sampled.
2. Lung function tests. Measurement of how quickly you can blow out after a deep breath (spirometry); lung volumes (plethysmography); and breathing in and blowing out against a resistance, as hard as you can (to test the strength of your breathing muscles). All these tests require you to breathe through a mouthpiece and wear a noseclip. You will be asked to sit on a chair inside a booth (about the size of a telephone box) that has a glass window and a glass door. There is the possibility that you may feel claustrophobic, however, the door can be opened by you from the inside at any time. In total, these tests will take 20 minutes, at most.
3. Anthropometry - measurement of your height, weight and waist circumference.

Two exercise tests will be performed (after screening for suitability to undertake intense exercise):
1. Incremental, symptom-limited exercise test. This test involves exercising on a stationary bike and you will be asked to pedal until you are too tired to continue or you request that the test be stopped or the researchers decide to stop the test – whichever comes first. This test will be supervised by a medical officer. This is an incremental test which means that the load (or resistance) that you are pedaling against will get harder every minute. During this test you will wear a noseclip and breathe through a mouthpiece so we can measure the amount and composition of the air that you breathe out; you will have electrodes attached to your chest to allow us to monitor heart rate and rhythm; you will have a small infrared sensor clipped lightly on one ear lobe to measure blood oxygen saturation; and you will have a blood pressure cuff attached to one arm. None of these attachments should cause you any discomfort. Towards the end of this test you can expect your muscles to feel tired and you will be breathing quite heavily and perspiring. This test usually takes, at most, about 10-12 minutes once you start pedaling.
2. Submaximal exercise test (incorporating cardiorespiratory tests to non-invasively measure your lungs’ diffusing capacity and lung blood flow): this test will be conducted on a stationary bike. In this test you will pedal at three different workloads (30, 60 and 90% of the final load you achieved in the first exercise test) for four minutes at each load. This test will not feel as hard as the symptom-limited peak exercise test. The same equipment that was attached to you in the incremental test will be used in this test too. In addition, we will perform the following procedures at rest and during exercise: At rest and at the end of testing at each workload we will ask you to breathe out fully, then breathe in one full breath of a gas mixture containing minute amounts of carbon monoxide, methane and acetylene (0.3%) and normal amounts of oxygen and nitrogen. We will then ask you to breathe out slowly. By measuring the concentration of gases in your exhaled breath, we will calculate lung blood flow and the capacity of your lung to exchange gas (diffusing capacity). This is a standard test used world-wide and there are no side-effects in breathing in the tiny quantities of carbon monoxide, methane and acetylene we will use for this study. This submaximal test will take about 16-20 minutes, inclusive of the rest period before starting to cycle.
We will provide you with morning tea after all testing has finished. All volunteers will be reimbursed for travel costs ($50).
Intervention code [1] 266922 0
Not applicable
Comparator / control treatment
Age- and gender-matched people without type 2 diabetes
Control group
Active

Outcomes
Primary outcome [1] 269160 0
diffusing capacity of the lung(DLCO) normalised to pulmonary blood flow(Q), i.e. DLCO/Q.
These tests of lung and heart function are conducted using a single breath (in and out slowly) of a gas mixture containing minute amounts of carbon monoxide, methane and acetylene (0.3%) and normal amounts of oxygen and nitrogen. By measuring the concentration of gases in an exhaled breath, we will calculate lung blood flow and the capacity of the lung to exchange gas (diffusing capacity). This is a standard test used world-wide and there are no side-effects in breathing in the tiny quantities of carbon monoxide, methane and acetylene we will use for this study. The gas is delivered and analysed by a machine (Sensormedics Vmax 229D) that has been approved by the Australian Therapeutic Goods Registry. The single breath of the gas mixture is taken once at rest and at the end of each of the three workrates through a mouthpiece (like a snorkel mouthpiece) that is held in place against your lips by a plastic frame that attaches comfortably to your head. This equipment will be worn for the duration of the exercise test.
Timepoint [1] 269160 0
rest; 30% workrate max; 60% workrate max; 90% workrate max. Both discrete timepoints and slope of the DLCO/Q line.
Secondary outcome [1] 279059 0
Static and dynamic lung volumes
These tests will be conducted at rest only, before you commence the exercise tests. The tests will measure how quickly you can blow out after a deep breath (spirometry); lung volumes (plethysmography); and respiratory muscle strength (breathing in and blowing out against a resistance, as hard as you can). All these tests require you to breathe through a mouthpiece and wear a noseclip. You will be asked to sit on a chair inside a booth (about the size of a telephone box) that has a glass window and a glass door. There is the possibility that you may feel claustrophobic, however, the door can be opened by you from the inside at any time.
Timepoint [1] 279059 0
rest
Secondary outcome [2] 279060 0
ventilation (VE) as a proportion of maximal voluntary ventilation (MVV)
This test is performed continuously during the exercise tests and just involves breathing through a mouthpiece (like a snorkel) that is attached to you by a light plastic headpiece. The flowrate of the air breathed out will be analysed by the Sensormedics Vmax machine and from that we determine ventilation.
Timepoint [2] 279060 0
rest; incremental exercise; submaximal exercise: 30, 60, 90, 100% max workrate
Secondary outcome [3] 279061 0
markers of systemic inflammation (IL-6, CRP, TNF-alpha) and their association to lung function
We will sample 20 mls of venous blood and later we will analyse it for concentrations of certain markers of low-grade systemic inflammation.
Timepoint [3] 279061 0
blood sampled at rest and related to DLCO at 90% max workrate

Eligibility
Key inclusion criteria
Patients with type 2 diabetes (T2D):
diagnosis of T2D (two fasting plasma glucose values >7.0 mmol/l and/or a 2-hr value >11.1 mmol/l in an oral glucose tolerance test)
aged between 18 and 40 years
onset of T2D before age 40 yrs (i.e. early-onset)
newly diagnosed (within 2 years of diagnosis)

Healthy controls without T2D:
aged between 18 and 40 years
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Healthy controls without T2D:
Family history of diabetes or evidence of insulin resistance (fasting glucose <5.6 mmol/l) or other metabolic disease

Both groups:
chronic respiratory disease; curent smoker or history of significant exposure to cigarette smoke; chest wall disease; heart failure; stroke; overt cardiovascular disease; any neurological condition precluding the ability to provide informed consent; and residence more than 50 km from the hospital

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/07/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267404 0
Charities/Societies/Foundations
Name [1] 267404 0
Physiotherapy Reserach Foundation - Jill Nosworthy Bequest
Country [1] 267404 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Research Portfolio,
Level 6, Jane Foss Russell Building, G02,
The University of Sydney,
NSW 2006
Country
Australia
Secondary sponsor category [1] 266462 0
None
Name [1] 266462 0
Address [1] 266462 0
Country [1] 266462 0
Other collaborator category [1] 252103 0
Hospital
Name [1] 252103 0
Royal Prince Alfred Hospital
Address [1] 252103 0
Missenden Road,
Camperdown, NSW 2050
Country [1] 252103 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269373 0
Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 269373 0
Research Development Office,
Royal Prince Alfred Hospital, Camperdown, NSW 2050
Ethics committee country [1] 269373 0
Australia
Date submitted for ethics approval [1] 269373 0
Approval date [1] 269373 0
04/07/2011
Ethics approval number [1] 269373 0
HREC/11/RPAH/72; protocol number X11-0060

Summary
Brief summary
Diabetes and obesity are global pandemics. Currently more than 25% of the Australian population are obese and the prevalence of diabetes is one of the highest of any developed nation. There is an alarming increase in diabesity in younger people and thus younger patients with more aggressive disease will increasingly present for treatment, e.g. exercise therapy, respiratory management of acute and chronic disorders, and for assessment and treatment of diabetes complications. To date, no study has investigated lung function during exercise and/or the effect of co-morbid obesity on pulmonary function in patients with newly-diagnosed type 2 diabetes. Given the potential of newly-diagnosed patients to institute lifestyle change, and the aggressive nature of early-onset diabetes, this group represents an ideal target for preventive and ameliorative therapies. However, prior to evaluating effects of therapy (e.g. weight loss, exercise training, improved glycaemic control), baseline data are required. This pilot study is thus designed to provide evidence that will facilitate targeted design of a larger clinical intervention trial.
This pilot study aims to quantify lung function at rest and during exercise in obese and non-obese patients with newly-diagnosed early-onset type 2 diabetes (T2D) compared with controls without diabetes.
Trial website
Nil
Trial related presentations / publications
Nil to date
Public notes

Contacts
Principal investigator
Name 32848 0
Dr Alison Harmer
Address 32848 0
Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, P.O. Box 170 Lidcombe, NSW 1825
Country 32848 0
Australia
Phone 32848 0
612 9351 9706
Fax 32848 0
612 9351 9278
Email 32848 0
alison.harmer@sydney.edu.au
Contact person for public queries
Name 16095 0
Dr Dr Alison Harmer
Address 16095 0
Discipline of Physiotherapy,
Faculty of Health Sciences,
The University of Sydney,
P.O. Box 170 Lidcombe, NSW 1825
Country 16095 0
Australia
Phone 16095 0
612 9351 9706
Fax 16095 0
612 9351 9278
Email 16095 0
alison.harmer@sydney.edu.au
Contact person for scientific queries
Name 7023 0
Dr Dr Alison Harmer
Address 7023 0
Discipline of Physiotherapy,
Faculty of Health Sciences,
The University of Sydney,
P.O. Box 170 Lidcombe, NSW 1825
Country 7023 0
Australia
Phone 7023 0
612 9351 9706
Fax 7023 0
612 9351 9278
Email 7023 0
alison.harmer@sydney.edu.au

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Results publications and other study-related documents

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