ObesityNCT02114008
Residual Gastric Volume in Morbidly Obesa Diabetics. A Comparison of 3 Hour Versus Hour Fasting.
A study testing Endoscopic examinations in people with Obesity and Diabetes, run by Cuiaba University at 1 site in Brazil.
Trial summary
To reduce the risk of aspiration for elective procedures, residual gastric volumes (RGV) have traditionally been minimized with overnight fasting. However, prolonged fasting can also have some adverse consequences and has been abandoned for some procedures in several patient populations with the exception of obese… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- What is being tested?
- Endoscopic examinations
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2013to Jun 2013
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria: patients between 18 and 55 years of age, of both sexes, with Body Index Mass (BMI) which is equal or greater than 40 Kg/m2, and type II diabetic that were using oral drugs or insulin to control the disease.
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Exclusion Criteria: patients who were using medications for gastrointestinal symptoms and/or who had prior abdominal operations.
-
Trial locations and contacts
1 site in 1 country.
About this study
To reduce the risk of aspiration for elective procedures, residual gastric volumes (RGV) have traditionally been minimized with overnight fasting. However, prolonged fasting can also have some adverse consequences and has been abandoned for some procedures in several patient populations with the exception of obese and/or diabetic patients. The aim of this study was to assess RGV in morbidly obese diabetic patients after traditional or abbreviated fasting.
Read the detailed description
Patients underwent two endoscopic examinations within two weeks. RGV was measured by aspiration of gastric contentes into a graduated cylinder after traditional fasting (at least 8 hours before the test) and after abbreviated fasting (3 hours with 200ml of water containing 25g of 12.5% maltodextrin). All patients received both oral and written information about the protocol at the outpatient clinic.
All the endoscopic procedures began at 9 AM, and were performed by the same board-certified endoscopist, JMS, who was blinded as to the duration of the fast. The endoscopies were conducted at Gastroclinica, Cuiaba, MT, in the period from April to June, 2013. Sedation was performed by a board-certified anesthesiologist, who was also blinded as to the duration of the fast. The anesthetic regimem included a intravenous bolus of 2 ml of lidocaine hydrochloride (Astra Zeneca, São Paulo, Brazil) followed by 100 to 150mg of propofol before endoscopy. Digital oximetry was monitored throughout the procedure. Patients were positioned in the lateral recumbent position. A flexible electronic videoendoscope (EG2770K; Pentax Corporation, Tokyo, Japan) of 9 mm in outer diameter was used. The main outcome variable was the RGV measured by the endoscopist after aspiration of gastric residue.
- Being tested
- Endoscopic examinations
- Keywords
- Gastric emptying., Residual gastric volume., Preoperative fasting., Morbid Obesity., Diabetes.
- Medical subject headings
- Obesity, Diabetes Mellitus, Fasting, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic examinationsOther
Patients underwent two endoscopic examinations within two weeks. RGV was measured by aspiration of gastric contentes into a graduated cylinder after traditional fasting (at least 8 hours before the test) and after abbreviated fasting (3 hours with 200ml of water containing 25g of 12.5% maltodextrin). All patients received both oral and written information about the protocol at the outpatient clinic.
| Study group | Role | What they receive |
|---|---|---|
| Abbreviated fasting | Active comparator | Patients underwent two endoscopic examinations within two weeks. RGV was measured by aspiration of gastric contentes into a graduated cylinder after traditional after abbreviated fasting (3 hours with 200ml of water containing 25g of 12.5% maltodextrin). Receives: Other: Endoscopic examinations |
| Traditional fasting | Active comparator | Patients underwent two endoscopic examinations within two weeks. RGV was measured by aspiration of gastric contentes into a graduated cylinder after traditional fasting (at least 8 hours before the test). Receives: Other: Endoscopic examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual gastric volume (RGV) in morbidly obese diabetics. A comparison of 3 hour versus 8 hour fasting
This was a prospective, randomized, double-blind, and cross-over design in 8 morbidly obese type II diabetics with informed consent. RGV was measured endoscopically after three and eight hour fasts.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startApr 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cuiaba University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gunther Peres Pimenta, Cuiaba University
- Investigators
- Gunther P Pimenta, MD, PhD, Principal investigator, Cuiaba University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114008
- Sponsor's protocol ID
- 179.017/2012 CEP UFMT
- Status last verified
- Apr 2014
- First submitted
- 12 Apr 2014
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual Gastric Volume in Morbidly Obesa Diabetics. A Comparison of 3 Hour Versus Hour Fasting.
- ClinicalTrials.gov ID
- NCT02114008
- Acronym / sponsor ID
- 179.017/2012 CEP UFMT
- Keywords
- Gastric emptying., Residual gastric volume., Preoperative fasting., Morbid Obesity., Diabetes.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Cuiaba UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Apr 2014 (estimated)
- 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.
To reduce the risk of aspiration for elective procedures, residual gastric volumes (RGV) have traditionally been minimized with overnight fasting. However, prolonged fasting can also have some adverse consequences and has been abandoned for some procedures in several patient populations with the exception of obese and/or diabetic patients. The aim of this study was to assess RGV in morbidly obese diabetic patients after traditional or abbreviated fasting.
Detailed description
Patients underwent two endoscopic examinations within two weeks. RGV was measured by aspiration of gastric contentes into a graduated cylinder after traditional fasting (at least 8 hours before the test) and after abbreviated fasting (3 hours with 200ml of water containing 25g of 12.5% maltodextrin). All patients received both oral and written information about the protocol at the outpatient clinic.
All the endoscopic procedures began at 9 AM, and were performed by the same board-certified endoscopist, JMS, who was blinded as to the duration of the fast. The endoscopies were conducted at Gastroclinica, Cuiaba, MT, in the period from April to June, 2013. Sedation was performed by a board-certified anesthesiologist, who was also blinded as to the duration of the fast. The anesthetic regimem included a intravenous bolus of 2 ml of lidocaine hydrochloride (Astra Zeneca, São Paulo, Brazil) followed by 100 to 150mg of propofol before endoscopy. Digital oximetry was monitored throughout the procedure. Patients were positioned in the lateral recumbent position. A flexible electronic videoendoscope (EG2770K; Pentax Corporation, Tokyo, Japan) of 9 mm in outer diameter was used. The main outcome variable was the RGV measured by the endoscopist after aspiration of gastric residue.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abbreviated fasting | Active comparator | Other: Endoscopic examinationsPatients underwent two endoscopic examinations within two weeks. RGV was measured by aspiration of gastric contentes into a graduated cylinder after traditional after abbreviated fasting (3 hours with 200ml of water containing 25g of 12.5% maltodextrin). |
| Traditional fasting | Active comparator | Other: Endoscopic examinationsPatients underwent two endoscopic examinations within two weeks. RGV was measured by aspiration of gastric contentes into a graduated cylinder after traditional fasting (at least 8 hours before the test). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 examinationsPatients underwent two endoscopic examinations within two weeks. RGV was measured by aspiration of gastric contentes into a graduated cylinder after traditional fasting (at least 8 hours before the test) and after abbreviated fasting (3 hours with 200ml of water containing 25g of 12.5% maltodextrin). All patients received both oral and written information about the protocol at the outpatient clinic. | Other | Abbreviated fasting, Traditional fasting |
Primary outcome
Residual gastric volume (RGV) in morbidly obese diabetics. A comparison of 3 hour versus 8 hour fasting
Time frame: 3 months
This was a prospective, randomized, double-blind, and cross-over design in 8 morbidly obese type II diabetics with informed consent. RGV was measured endoscopically after three and eight hour fasts.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
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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.
Gunther P Pimenta, MD, PhD principal investigator
Cuiaba 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 examinations in people with Obesity and Diabetes, run by Cuiaba University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 15 Apr 2014. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual gastric volume (RGV) in morbidly obese diabetics. A comparison of 3 hour versus 8 hour fasting (time frame: 3 months). 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 15 Apr 2014.