EndoscopyNCT03901040
Evaluation of the Role of Endoscopic Ultrasound Guided Gastric Botulinum Toxin Injection in the Treatment of Obesity.
A study testing endoscopic ultrasound in people with Endoscopy, run by Mansoura University at 1 site in Egypt.
Trial summary
Background: Gastric injections of Botulinum toxin A (BTA) may induce changes in gastric emptying and body weight, but results vary. BTA dose and depth of injection may affect efficacy. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Endoscopy
- What is being tested?
- endoscopic ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Aug 2017to 22 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sex: both
- Age: from 20 to 60 years
- Body Mass Index > 30
Who cannot join
- Age: below 20 or above 60 years old.
- Patient with known gastroparesis
- Peptic ulcer disease or active upper gastrointestinal ulceration
- Prior gastric or small bowel surgery
- American Society of Anesthesiologists (ASA) class 3 or higher
- Patients with more than mild , infrequent symptoms of upper abdominal pain or nausea
- Pregnant or lactating female
- Contraindications of sedation (Uncontrolled Diabetes Mellitus, Uncontrolled Thyroid Disorders, Pregnancy, Respiratory Embarrassment, Reactional Drugs like Antidepressants and Anti-anxiety Agents).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Specialized Medical Hospital,Mansoura University
Al Mansurah, Dakhlia, 35516
Asmaa G Ahmed, 01025835429 ext. 20, asmaagameel165@gmail.com
Ahmed Y Altonbary, 01005100091 ext. 20, a.altonbary@gmail.com
About this study
Official title: Evaluation of the Role of Endoscopic Ultrasound Guided Botulinum Toxin Injection in the Treatment of Obesity
Background: Gastric injections of Botulinum toxin A (BTA) may induce changes in gastric emptying and body weight, but results vary. BTA dose and depth of injection may affect efficacy. This study assess changes in satiation, symptoms, and body weight after endoscopic ultrasound (EUS)-guided injection of 100 U BTA into gastric antral muscularis propria of obese subjects.
Methods: Open label study of twenty five healthy, obese adults (age=21-49 years, body mass index 35 = kg/m2) who received 100 U and were followed for 16 weeks. Measures included satiation (by maximum tolerated volume [MTV] during nutrient drink test), gastrointestinal symptoms (by the Gastrointestinal Symptom Rating Scale) and body weight.
Read the detailed description
Subjects:
Twenty five overweight, healthy subjects were recruited. Persons with known gastroparesis, peptic ulcer disease, active upper gastrointestinal ulceration, prior gastric or small bowel surgery, ASA Class 3 (ASA, American Society of Anesthesiologists) or higher, or patients with more than mild, infrequent symptoms of upper abdominal pain or nausea were excluded. Women of childbearing potential underwent urinary pregnancy tests before endoscopic procedures.
Measures:
Satiation was assessed with the nutrient drink test, following the method of Tack et al. Subjects ingested 120 ml of a nutrient drink (Ensure®) per 4 min. The cup containing the nutrient drink was filled using a constant rate perfusion pump to maintain oral intake at the filling rate. Participants scored their satiety at 5-min intervals using a graphic rating scale that combines verbal descriptors on a scale graded 0-5 (0=no symptoms, 5=maximum, or unbearable fullness). Participants stopped meal intake when a score of 5 was reached, and the maximum tolerated volume (MTV) of nutrient drink was recorded. Normal values for MTV in adults in our laboratory are ≥850 cc. Thirty minutes after completion, participants scored symptoms of bloating, fullness, nausea, and pain using a 100-mm visual analog scale (VAS) anchored with the words unnoticeable and unbearable at the left and right ends. The aggregate symptom score was defined as the sum of the VAS scores for each symptom (i.e., maximum 400).
Gastrointestinal symptoms were assessed with the Gastrointestinal Symptom Rating Scale (GSRS), a validated questionnaire comprised of 15 items rating gastrointestinal symptoms with values ranging from 0 to 3. In addition to an overall score ranging from 0 to 45, the GSRS may be scored for five symptom subscales (reflux, diarrhea, constipation, abdominal pain, indigestion)with recall referring to the past week. It is responsive to change.
Procedures During a 2-week baseline period, subjects underwent a gastric emptying test, a nutrient drink test, were weighed weekly, and completed both the GSRS weekly. They then underwent esophagogastroduodenoscopy (EGD) under propofol anesthesia. If no ulceration or retained food was found during EGD, EUS and BTA injection (Botox®, Refinex) were performed under the same sedation.
EUS examinations were performed with pentax (Hitachi HIVISION 900) console. ??). BTA injections were made via a 25-gauge EUS needle. Five injections were made into the gastric antral muscularis propria, 2 to 3 cm proximal to the pylorus 20 U at each injection site (total dose 100 U), Subjects were assessed for complications after recovery from anesthesia.
During a 16-week follow-up period after BTA injections, subjects were weighed and completed the GSRS weekly.
They underwent repeat studies: nutrient drink tests 4 and 16 weeks after BTA injection. No behavioral or dietary interventions were offered to study subjects.
- Conditions
- Endoscopy
- Being tested
- endoscopic ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic ultrasoundDevice
endoscopic ultrasound with boutlinum toxin injection in the antrum of the stomach to decrease satiety
| Study group | Role | What they receive |
|---|---|---|
| obese patient | Other | we will perform endoscopic ultrasound botulinum toxin (100 IU)injection to gastric antrum of obese patient with BMI more than 30 will Receives: Device: endoscopic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
follow up weight and satiety of the patient weekly
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start22 Aug 2017
- Primary completion22 Apr 2019 (estimated)
- Study completion22 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndoscopyStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Gameel, Mansoura University
- Investigators
- Mounir H Bahgat, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901040
- Sponsor's protocol ID
- MD/17.08.92
- Status last verified
- Apr 2019
- First submitted
- 12 Jan 2019
- Last updated
- 3 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Endoscopic Ultrasound Guided Botulinum Toxin Injection in the Treatment of Obesity
- ClinicalTrials.gov ID
- NCT03901040
- Acronym / sponsor ID
- MD/17.08.92
- Conditions
- Endoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 22 Apr 2019 (estimated)
- Study completion
- 22 Aug 2019 (estimated)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Gastric injections of Botulinum toxin A (BTA) may induce changes in gastric emptying and body weight, but results vary. BTA dose and depth of injection may affect efficacy. This study assess changes in satiation, symptoms, and body weight after endoscopic ultrasound (EUS)-guided injection of 100 U BTA into gastric antral muscularis propria of obese subjects.
Methods: Open label study of twenty five healthy, obese adults (age=21-49 years, body mass index 35 = kg/m2) who received 100 U and were followed for 16 weeks. Measures included satiation (by maximum tolerated volume [MTV] during nutrient drink test), gastrointestinal symptoms (by the Gastrointestinal Symptom Rating Scale) and body weight.
Detailed description
Subjects:
Twenty five overweight, healthy subjects were recruited. Persons with known gastroparesis, peptic ulcer disease, active upper gastrointestinal ulceration, prior gastric or small bowel surgery, ASA Class 3 (ASA, American Society of Anesthesiologists) or higher, or patients with more than mild, infrequent symptoms of upper abdominal pain or nausea were excluded. Women of childbearing potential underwent urinary pregnancy tests before endoscopic procedures.
Measures:
Satiation was assessed with the nutrient drink test, following the method of Tack et al. Subjects ingested 120 ml of a nutrient drink (Ensure®) per 4 min. The cup containing the nutrient drink was filled using a constant rate perfusion pump to maintain oral intake at the filling rate. Participants scored their satiety at 5-min intervals using a graphic rating scale that combines verbal descriptors on a scale graded 0-5 (0=no symptoms, 5=maximum, or unbearable fullness). Participants stopped meal intake when a score of 5 was reached, and the maximum tolerated volume (MTV) of nutrient drink was recorded. Normal values for MTV in adults in our laboratory are ≥850 cc. Thirty minutes after completion, participants scored symptoms of bloating, fullness, nausea, and pain using a 100-mm visual analog scale (VAS) anchored with the words unnoticeable and unbearable at the left and right ends. The aggregate symptom score was defined as the sum of the VAS scores for each symptom (i.e., maximum 400).
Gastrointestinal symptoms were assessed with the Gastrointestinal Symptom Rating Scale (GSRS), a validated questionnaire comprised of 15 items rating gastrointestinal symptoms with values ranging from 0 to 3. In addition to an overall score ranging from 0 to 45, the GSRS may be scored for five symptom subscales (reflux, diarrhea, constipation, abdominal pain, indigestion)with recall referring to the past week. It is responsive to change.
Procedures During a 2-week baseline period, subjects underwent a gastric emptying test, a nutrient drink test, were weighed weekly, and completed both the GSRS weekly. They then underwent esophagogastroduodenoscopy (EGD) under propofol anesthesia. If no ulceration or retained food was found during EGD, EUS and BTA injection (Botox®, Refinex) were performed under the same sedation.
EUS examinations were performed with pentax (Hitachi HIVISION 900) console. ??). BTA injections were made via a 25-gauge EUS needle. Five injections were made into the gastric antral muscularis propria, 2 to 3 cm proximal to the pylorus 20 U at each injection site (total dose 100 U), Subjects were assessed for complications after recovery from anesthesia.
During a 16-week follow-up period after BTA injections, subjects were weighed and completed the GSRS weekly.
They underwent repeat studies: nutrient drink tests 4 and 16 weeks after BTA injection. No behavioral or dietary interventions were offered to study subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obese patient | Other | Device: endoscopic ultrasoundwe will perform endoscopic ultrasound botulinum toxin (100 IU)injection to gastric antrum of obese patient with BMI more than 30 will |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Sex: both
- Age: from 20 to 60 years
- Body Mass Index > 30
Key exclusion criteria (8 listed)
- Age: below 20 or above 60 years old.
- Patient with known gastroparesis
- Peptic ulcer disease or active upper gastrointestinal ulceration
- Prior gastric or small bowel surgery
- American Society of Anesthesiologists (ASA) class 3 or higher
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic ultrasoundendoscopic ultrasound with boutlinum toxin injection in the antrum of the stomach to decrease satiety | Device | obese patient |
Primary outcome
weight loss
Time frame: 16 weeks
follow up weight and satiety of the patient weekly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mounir H Bahgat study chair
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic ultrasound in people with Endoscopy, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa G Ahmed, Master (01025835429 ext. 20, asmaagameel165@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight loss (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.