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Trial registered on ANZCTR


Registration number
ACTRN12617001485325
Ethics application status
Approved
Date submitted
19/09/2017
Date registered
20/10/2017
Date last updated
8/10/2019
Date data sharing statement initially provided
8/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects and Mechanisms of Action of Endoscopic Sleeve Gastroplasty Utilising the Overstitch Procedure in Obese Patients with Type 2 Diabetes
Scientific title
Effects and Mechanisms of Action of Endoscopic Sleeve Gastroplasty Utilising the Overstitch Procedure in Obese Patients with Type 2 Diabetes
Secondary ID [1] 292929 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 304809 0
Obesity 304811 0
Condition category
Condition code
Metabolic and Endocrine 304105 304105 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project will be a single centre, one-armed interventional trial. 15 patients will undergo an endoscopic sleeve gastroplasty (ESG) procedure. During the procedure, a small tube (the endoscope) is inserted through the mouth and passed down the oesophagus into the stomach and proximal small bowel for visual examination of the upper gut by the physician. The endoscope will be removed and provided the endoscopic examination of the upper gut is normal a stitching device (Overstitch, Apollo Endosurgery) will be attached to the endoscope tip. Then the endoscope will be re-inserted and used to stitch the walls of the stomach together to create a smaller volume residual stomach in the form of a tube. This usually requires between 3 and 5 stitches to be placed. These stitches will remain in the stomach indefinitely but can potentially be removed if required. After the procedure the physician will assess and decide if a patient can be discharged the same day or if they may need to stay overnight in hospital so the physician can monitor and treat potential post-procedural symptoms (e.g. nausea, discomfort).
Investigations will be performed at baseline, immediately prior to their ESG and following their ESG procedure. Patients will follow our protocolled testing as well as medical and allied health protocolled review as per our follow up schedule over a 12 month follow up period.
Intervention code [1] 299161 0
Treatment: Devices
Intervention code [2] 299418 0
Treatment: Surgery
Comparator / control treatment
The data will be compared to the study group baseline characteristics and to the results of a currently still ongoing trial conducted at our Department. In this ongoing trial a group of 15 patients underwent a temporary duodenal-jejunal bypass sleeve insertion (Endobarrier; GI Dynamics Inc., Lexington, Massachusetts, USA) (HREC/QPAH/15/246), which is a different endoscopic bariatric therapy.
The comparator study commenced on 16/11/2015 and will be completed 01/07/2018.
The registration number is 12615001229561
Control group
Historical

Outcomes
Primary outcome [1] 303433 0
Weight loss - assessed via weight on digital scales at each appointment
Timepoint [1] 303433 0
Measured at initial appointment, baseline (device insertion), weeks 4,8,16,24,36,48,52
Secondary outcome [1] 338921 0
Health related quality of life as measured by the SF-36v2
Timepoint [1] 338921 0
Measured at initial visit and weeks 24, 48 and 52
Secondary outcome [2] 338924 0
Psychological wellbeing measured by the Hospital Anxiety and Depression Scale
Timepoint [2] 338924 0
Measured at initial visit and weeks 24, 48 and 52
Secondary outcome [3] 338925 0
Pancreatic exocrine functional testing as measured by a 13C labeled mixed triglyceride breath test
Timepoint [3] 338925 0
measured at initial visit and weeks 8, 48 and 52
Secondary outcome [4] 338926 0
Fasting insulin measured via blood assay
Timepoint [4] 338926 0
Blood panels conducted at initial visit and weeks 8, 48 and 52
Secondary outcome [5] 338927 0
Composite secondary outcome measure of cardiopulmonary reserve and exercise capacity measured by a 6 minute walk test
Timepoint [5] 338927 0
measured at initial visit and weeks 24, 48 and 52.
Secondary outcome [6] 338928 0
Fasting Blood glucose measured by blood assay
Timepoint [6] 338928 0
Blood panels conducted at initial visit and weeks 8, 48 and 52
Secondary outcome [7] 338929 0
Stool microbiome community profiling will enable characterisation of the bacterial diversity of the gastric and duodenal mucosa-associated microbiome.
Timepoint [7] 338929 0
Initial visit and weeks 8,48 and 52
Secondary outcome [8] 339938 0
Gastric emptying as measured by 13C Octanoid breath test
Timepoint [8] 339938 0
Initial visit and weeks 24, 48 and 52
Secondary outcome [9] 339939 0
Liver function measured by non-invasive hepatic elastography.
Timepoint [9] 339939 0
Initial visit and weeks 24, 48 and 52
Secondary outcome [10] 339941 0
Visceral sensitivity as measured by a Standard Nutrient challenge test.
Timepoint [10] 339941 0
Initial visit and weeks 4, 24, 48 and 52
Secondary outcome [11] 339942 0
Self reported diet quality as measured by diet history and 24 hour recall
Timepoint [11] 339942 0
Initial visit and weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52
Secondary outcome [12] 339943 0
Gastrointestinal symptoms assessed by Gastrointestinal Symptom Score
Timepoint [12] 339943 0
Initial visit and weeks 4.8,24,48 and 52.
Secondary outcome [13] 339944 0
Body composition assessment as measured by Dual-energy X-ray absorptiometry
Timepoint [13] 339944 0
Initial visit and weeks 48 and 52.

Eligibility
Key inclusion criteria
1. Aged between 18 and 65 years.
2. Functional level equivalent to an ECOG score of 2 or less.
3. Obese – BMI >35 kg/m2.
4. Type II diabetes mellitus on oral hypoglycaemic agents but not insulin.
5. English speaking.
6. Willing to participate in a 1 year trial and with capacity to consent.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria prior to recruitment will include:
1. Prior gastric or intestinal surgery including (not exclusively) the following:
a. Nissen Fundoplication, gastrectomy,
b. Vertical Banded Gastroplasty, Gastric Bypass, gastric partitioning, gastric stapling, gastric resection, placement of the LAPBAND™ System,
c. Small bowel resection, colon resection, colostomy,
2. Any inflammatory disease of the gastrointestinal tract including oesophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn’s disease.
3. Potential upper gastrointestinal bleeding conditions such as oesophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.
4. A large hiatal hernia.
5. A structural abnormality in the oesophagus or pharynx such as a stricture or significant diverticulum.
6. Significant coronary artery disease. (Previous myocardial infarction or angina in the past 90 days.)
7. Any medical condition that requires or is likely to require anticoagulation or dual anti-platelet therapy during the study period.
8. Any active malignancy.
9. Any medical condition with a likely survival of 5 years or less.
10. Any patient likely to require abdominal surgery during the study period.
11. Patient or family history of connective tissue disease.
12. Patient or family history of gastric precancerous or cancerous lesions
13. Any upper gastrointestinal abnormality or anatomical variant that may interfere with this procedure.
14. Pregnancy.
15. Known chronic pancreatitis.
16. Poor functional status ECOG greater than or equal to 3.
17. Antibiotic use at the time of endoscopy.
18. Any other medical condition, which would not permit elective endoscopy.
19. Major prior or present psychological or psychiatric disorder including alcoholism or drug addiction.

Exclusion criteria after recruitment will include:
1. Inadequate cardiopulmonary reserve for anaesthetisation.
2. Structural or mucosal abnormality found during upper endoscopy that would preclude an endoscopic sleeve gastroplasty.
3. Withdrawal of consent.
4. Clinician concern regarding any of the above exclusion criteria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This project will be a single centre, one-armed interventional trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations were not performed as this is a pilot trial and number was selected on maximal resource allowance.
Data will be statistically analysed in house by adequately trained staff

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2017
Actual
1/03/2018
Date of last participant enrolment
Anticipated
30/09/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9071 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 17564 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 297555 0
Hospital
Name [1] 297555 0
Princess Alexandra Hospital
Country [1] 297555 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
199 Ipswich Rd
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 296565 0
None
Name [1] 296565 0
Address [1] 296565 0
Country [1] 296565 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298652 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 298652 0
PAH Centres for Health Research
Level 7 Translational Research Institute
37 Kent St
Woolloongabba QLD 4102
Ethics committee country [1] 298652 0
Australia
Date submitted for ethics approval [1] 298652 0
03/08/2017
Approval date [1] 298652 0
03/10/2017
Ethics approval number [1] 298652 0
HREC/17/QPAH/480

Summary
Brief summary
This project aims to observe the effects of an endoscopic sleeve gastroplasty utilising the overstitch procedure for the treatment of obesity and diabetes which is an increasing problem in our community.
During the procedure, a small tube (the endoscope) is inserted through your mouth and passed down your oesophagus into the stomach and proximal small bowel for visual examination of the upper gut by the physician.
The endoscope will be removed and provided the endoscopic examination of your upper gut was normal a stitching device (Overstitch, Apollo Endosurgery) will be attached to the endoscope tip. Then the endoscope will be reinserted and used to stitch the walls of the stomach together to create a smaller volume residual stomach in the form of a tube. This usually requires between 3 and 5 stitches to be placed. These stitches will remain in the
stomach indefinitely but can potentially be removed if required.
This study will also look to assess the following outcomes
• Weight loss - assessed via weight on digital scales at each appointment
• Health related quality of life as measured by the SF-36v2
• Psychological wellbeing measured by the Hospital Anxiety and Depression Scale
• Pancreatic exocrine functional testing as measured by a 13C labeled mixed triglyceride breath test as measured by a 13C labeled mixed triglyceride breath test
• Fasting insulin measured via blood assay
• Composite secondary outcome measure of cardiopulmonary reserve and exercise capacity measured by a 6 minute walk test
• Fasting Blood glucose measured by blood assay
• Stool microbiome community profiling will enable characterisation of the bacterial diversity of the gastric and duodenal mucosa-associated microbiome.
• Gastric emptying as measured by 13C Octanoid breath test
• Liver function measured by non-invasive hepatic elastography.
• Body composition assessment as measured by Dual-energy X-ray absorptiometry
• Visceral sensitivity as measured by a Standard Nutrient challenge test.
• Self reported diet quality as measured by diet history and 24 hour recall
• Gastrointestinal
This study will enroll 15 obese type 2 diabetic patients (males and females) recruited from the “Obesity clinic” run by the Department of Endocrinology, general practice referrals or on the waiting list for another study HREC/QPAH/15/246. Patients will be followed up for a period of 1 year from the time of procedure and assessed for changes in the above mentioned variables throughout the follow up period.
The data will be compared to the study group baseline characteristics and to the results of a currently still ongoing trial conducted at our Department. In this ongoing trial a group of 15 patients underwent a temporary duodenaljejunal bypass sleeve insertion
(HREC/QPAH/15/246).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77774 0
Prof Gerald Holtmann
Address 77774 0
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba QLD 4102
Queensland
Australia
Country 77774 0
Australia
Phone 77774 0
+61 7 3176 7792
Fax 77774 0
Email 77774 0
[email protected]
Contact person for public queries
Name 77775 0
Dr Natasha Koloski
Address 77775 0
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba QLD 4102
Country 77775 0
Australia
Phone 77775 0
+61 7 3176 7792
Fax 77775 0
Email 77775 0
[email protected]
Contact person for scientific queries
Name 77776 0
Prof Gerald Holtmann
Address 77776 0
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba QLD 4102
Country 77776 0
Australia
Phone 77776 0
+61 7 3176 7792
Fax 77776 0
Email 77776 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
Only group data will be made available.


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.