Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001593820
Ethics application status
Approved
Date submitted
19/10/2021
Date registered
22/11/2021
Date last updated
14/01/2022
Date data sharing statement initially provided
22/11/2021
Date results information initially provided
22/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of insulin resistance, obesity and the metabolic syndrome on time taken to examine the small bowel at capsule endoscopy
Scientific title
Impact of insulin resistance, obesity and the metabolic syndrome on small bowel transit time at capsule endoscopy
Secondary ID [1] 305568 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 323982 0
Insulin resistance 323983 0
Metabolic syndrome 323984 0
Obscure gastrointestinal bleeding 323985 0
Condition category
Condition code
Oral and Gastrointestinal 321483 321483 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Diet and Nutrition 321484 321484 0 0
Obesity
Metabolic and Endocrine 321485 321485 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study. All patients undergoing video capsule endoscopy that are recruited will have clinical parameters recorded (sex, age, height, weight, waist circumference, blood pressure and body mass index). A fasting blood sample will be collected for insulin, glucose and full lipid profile (total cholesterol, triglycerides, high density lipoprotein (HDL), low density lipoprotein (LDL)). Insulin resistance is to be calculated using the validated HOMA-IR (homeostasis model of assessment of insulin resistance) method. Participants are asked about the relevant past medical history (medically diagnosed diabetes, dyslipidaemia, hypertension, ischaemic heart disease, cerebrovascular disease or peripheral vascular disease) and medications.

The capsule endoscope system takes about 10 minutes to be connected and swallowed. The recorder is worn for 10-12 hours. Data and blood test samples are collected before the capsule endoscopy procedure and this takes about 15 minutes.
Intervention code [1] 321967 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329262 0
Small intestinal transit time which is measured routinely by the clinician reading the study. The value is accessed from the capsule endoscopy report.
Timepoint [1] 329262 0
At time of capsule endoscopy
Secondary outcome [1] 401940 0
Gastric transit time which is measured routinely by the clinician reading the study. The value is accessed from the capsule endoscopy report.
Timepoint [1] 401940 0
At time of capsule endoscopy
Secondary outcome [2] 401941 0
Complete enteroscopy which is measured routinely by the clinician reading the study. The value is accessed from the capsule endoscopy report.
Timepoint [2] 401941 0
At time of capsule endoscopy

Eligibility
Key inclusion criteria
All patients being referred for capsule endoscopy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide informed consent

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Consecutive patients undergoing capsule endoscopy during the study period were recruited. The association between study variables and the outcomes were compared using a one-way analysis of the variance with t-testing. P values of less than or equal to 0.05 were considered significant. A multivariate multiple linear regression model was used to calculate the adjusted means of the clinical outcomes. All determinants with p-values of less than or equal to 0.25 were entered together in the full model of linear regression, and the model was reduced by excluding variables with p-values of greater than or equal to 0.05. Statistical analyses were performed using SAS version 9.00 (SAS Institute Inc., Cary, NC, USA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2009
Date of last participant enrolment
Anticipated
Actual
30/09/2010
Date of last data collection
Anticipated
Actual
30/09/2010
Sample size
Target
150
Accrual to date
Final
156
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20771 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 35582 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 309932 0
Hospital
Name [1] 309932 0
Department of Gastroenterology
Country [1] 309932 0
Australia
Primary sponsor type
Individual
Name
Dr Milan Bassan
Address
Department of Gastroenterology
Wollongong Hospital
Loftus St, Wollongong NSW 2500
Country
Australia
Secondary sponsor category [1] 310968 0
None
Name [1] 310968 0
Address [1] 310968 0
Country [1] 310968 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309651 0
University of Wollongong/SE Sydney and Illawara Area Health Service Health and Medical HREC
Ethics committee address [1] 309651 0
Research Services Office
University of Wollongong
Wollongong, NSW, 2522
Ethics committee country [1] 309651 0
Australia
Date submitted for ethics approval [1] 309651 0
Approval date [1] 309651 0
07/08/2009
Ethics approval number [1] 309651 0
HE09/136

Summary
Brief summary
All patients already referred for capsule endoscopy during the study period over the age of 18 years old and are able to provide informed consent are to be invited to participate in the study.
Capsule endoscopy is where a camera and wireless transmitter are packaged in a small, pill shaped device. This is swallowed by the patient and images are recorded as the devices passes through the bowel. These images are then interpreted to help diagnose intestinal disorders. This procedure is usually undertaken to investigate anaemia and obscure gastrointestinal bleeding. Incomplete studies can limit the utility of the study and identification of factors that may impact transit will help identify patients at risk of incomplete examination.
Those that do consent will have clinical parameters recorded (sex, age, height, weight, waist circumference, blood pressure and body mass index). A fasting blood sample will be collected for insulin, C-peptide, glucose and full lipid profile (total cholesterol, triglycerides, high density lipoprotein (HDL), low density lipoprotein (LDL)). Insulin resistance is to be calculated using the validated HOMA-IR (homeostasis model of assessment of insulin resistance) method. Participants are asked about the relevant past medical history (medically diagnosed diabetes, dyslipidaemia, hypertension, ischaemic heart disease, cerebrovascular disease or peripheral vascular disease) and medications.
At capsule endoscopy gastric emptying and small bowel transit time are recorded as well as whether complete small bowel transit occurs and any pathology encountered. All capsule endoscopy studies will be interpreted by an experienced clinician. Standard capsule endoscopy techniques are to be followed.
Patient information is to be de-identified before statistical analysis. No individually identifiable information will be included in the final results.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114906 0
Dr Milan Bassan
Address 114906 0
Department of Gastroenterology and Hepatology
Liverpool Hospital
Elizabeth Street
Liverpool 2170
New South Wales
Country 114906 0
Australia
Phone 114906 0
+61 0408911125
Fax 114906 0
+610296017789
Email 114906 0
[email protected]
Contact person for public queries
Name 114907 0
Dr Milan Bassan
Address 114907 0
Department of Gastroenterology and Hepatology
Liverpool Hospital
Elizabeth Street
Liverpool 2170
New South Wales
Country 114907 0
Australia
Phone 114907 0
+61 0296017766
Fax 114907 0
+610296017789
Email 114907 0
[email protected]
Contact person for scientific queries
Name 114908 0
Dr Milan Bassan
Address 114908 0
Department of Gastroenterology and Hepatology
Liverpool Hospital
Elizabeth Street
Liverpool 2170
New South Wales
Country 114908 0
Australia
Phone 114908 0
+61 0296017766
Fax 114908 0
+610296017789
Email 114908 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

Documents added automatically
No additional documents have been identified.