To Evaluate Clinical Results, Insulin Resistance and Inflammatory Response to Trauma in Morbidly Obese PatientsNCT02113995
Clinical Evaluation, Organic Response in Obesity Patients Subjected to Vertical Videolaparoscopy Gastroplasty With or Without Perioperative Cares Recommended by the Acerto Project. Randomized Study.
A study testing ACERTO protocol vs Traditional care in people with To Evaluate Clinical Results, Insulin Resistance and Inflammatory Response to Trauma in Morbidly Obese Patients, run by Cuiaba University at 1 site in Brazil.
Trial summary
Background To evaluate clinical results, insulin resistance and inflammatory response to trauma in morbidly obese patients undergoing laparoscopic Sleeve gastrectomy who received either traditional preoperative care or treatment following the ACERTO protocol. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- To Evaluate Clinical Results, Insulin Resistance and Inflammatory Response to Trauma in Morbidly Obese Patients
- What is being tested?
- ACERTO protocol vs Traditional care
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2012to Oct 2012
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria: We included patients who are between 18 and 45 years of age, from both sexes, with an initial BMI (Body Mass Index) which is equal to or greater than 40 kg/m2, candidates for the sleeve surgery procedure through laparoscopy.
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Exclusion Criteria: We excluded the patients who didn't follow the fasting protocol and also those whose laboratory exams were lost.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation, Organic Response in Obesity Patients Subjected to Vertical Videolaparoscopy Gastroplasty With or Without Perioperative Cares Recommended by the Acerto Project.
Background To evaluate clinical results, insulin resistance and inflammatory response to trauma in morbidly obese patients undergoing laparoscopic Sleeve gastrectomy who received either traditional preoperative care or treatment following the ACERTO protocol.
Read the detailed description
Methods The population of the study consisted of morbidly obese patients, who were operated on with the Sleeve procedure, from Cuiaba, MT, between April and October 2012. We studied the inflammatory response and insulin resistance by measuring levels of glucose, insulin, Homa IR, reactive C protein, albumin, pre-albumin, alpha 1 acid glicoprotein, interleukin 6 and glycosylated hemoglobin. We also studied hydration, nausea and vomiting, hypertension, and length of hospital stay.
- Being tested
- ACERTO protocol vs Traditional care
- Keywords
- Obesity, Morbid, Insulin Resistance, Acute-Phase Reaction, Gastroplasty, Length of Stay, Protocols, Randomized Controlled Trial.
- Medical subject headings
- Insulin Resistance, Obesity, Morbid, Acute-Phase Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACERTO protocol vs Traditional careOther
Three sample blood collections were performed, being one in the anesthesic induction and the others in the next 24 to 48 hours. The blood was sent to the laboratory for dosages of glucose, insulin, C-reactive protein, albumin, prealbumin, alpha 1 acid glycoprotein and interleukin 6. During the anesthesic induction we also collected blood for analize glycosylated hemoglobin.
| Study group | Role | What they receive |
|---|---|---|
| ACERTO | Active comparator | Patients received 400 ml of a beverage containing water and 50 g of maltodextrin 6 hours before the operation. They received orally extra 200 ml of this beverage containing water and 25 g of maltodextrin 3 hours before the operation. Regarding the intravenous fluids, they received 1 to 1.5 liter of crystalloid fluids (ringer lactate) in the intraoperative. In the immediate postoperative they were programmed to receive 2 liters of crystalloid fluids (ringer lactate) and 1 to 2 liters in the first day of the postoperative period. The venous hydration was suspended as soon as they started to drink liquids.
Prophylaxis of nausea and vomiting with dexamethasone 8 mg at the beginning of the anesthesia and ondansetron 4-8 mg after the surgery. In the postoperative period we utilized analgesics such as dipyrone and ketorolac and, if necessary, low doses of morphine and antiemetics like ondansetron. Receives: Other: ACERTO protocol vs Traditional care |
| Traditional care | Active comparator | The analgesia in the postoperative period of the group control was performed with dipyrone, tramadol hydrochloride, and morphine. The prophylaxis of nausea and vomiting with dexamethasone 8 mg in the beginning of the anesthesia and the metoclopramide at the end of the surgery. During the anesthetic induction antibiotic prophylaxis (cefazolin 3 grams/day for 2 days) was administrated.
The control group were submitted to the protocol of traditional fasting with at least 8 hours. Patients in this group received 1 to 2 liters of crystalloid fluid (ringer lactate) in the intraoperative, and they received 3 to 4 liters of crystalloid fluids (ringer lactate, saline 0.9% and/or dextrose 5%). In the immediate postoperative, 2 to 3 liters in the first day of postoperative and, finally, 1 to 2 liters in the second day of the postoperative. Receives: Other: ACERTO protocol vs Traditional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACERTO protocol
To evaluate clinical results, insulin resistance and inflammatory response to trauma in morbidly obese patients undergoing laparoscopic Sleeve gastrectomy who received either traditional preoperative care or treatment following the ACERTO protocol.
Measured: 6 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 2012
- Primary completionJun 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Evaluate Clinical Results, Insulin Resistance and Inflammatory Response to Trauma in Morbidly Obese PatientsStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT02113995
- Sponsor's protocol ID
- 018/CEP-UNIC/2011.
- 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
- Clinical Evaluation, Organic Response in Obesity Patients Subjected to Vertical Videolaparoscopy Gastroplasty With or Without Perioperative Cares Recommended by the Acerto Project.
- ClinicalTrials.gov ID
- NCT02113995
- Acronym / sponsor ID
- 018/CEP-UNIC/2011.
- Keywords
- Obesity, Morbid, Insulin Resistance, Acute-Phase Reaction, Gastroplasty, Length of Stay, Protocols, Randomized Controlled Trial.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cuiaba UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Oct 2012 (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.
Background To evaluate clinical results, insulin resistance and inflammatory response to trauma in morbidly obese patients undergoing laparoscopic Sleeve gastrectomy who received either traditional preoperative care or treatment following the ACERTO protocol.
Detailed description
Methods The population of the study consisted of morbidly obese patients, who were operated on with the Sleeve procedure, from Cuiaba, MT, between April and October 2012. We studied the inflammatory response and insulin resistance by measuring levels of glucose, insulin, Homa IR, reactive C protein, albumin, pre-albumin, alpha 1 acid glicoprotein, interleukin 6 and glycosylated hemoglobin. We also studied hydration, nausea and vomiting, hypertension, and length of hospital stay.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACERTO | Active comparator | Other: ACERTO protocol vs Traditional carePatients received 400 ml of a beverage containing water and 50 g of maltodextrin 6 hours before the operation. They received orally extra 200 ml of this beverage containing water and 25 g of maltodextrin 3 hours before the operation. Regarding the intravenous fluids, they received 1 to 1.5 liter of crystalloid fluids (ringer lactate) in the intraoperative. In the immediate postoperative they were programmed to receive 2 liters of crystalloid fluids (ringer lactate) and 1 to 2 liters in the first day of the postoperative period. The venous hydration was suspended as soon as they started to drink liquids. Prophylaxis of nausea and vomiting with dexamethasone 8 mg at the beginning of the anesthesia and ondansetron 4-8 mg after the surgery. In the postoperative period we utilized analgesics such as dipyrone and ketorolac and, if necessary, low doses of morphine and antiemetics like ondansetron. |
| Traditional care | Active comparator | Other: ACERTO protocol vs Traditional careThe analgesia in the postoperative period of the group control was performed with dipyrone, tramadol hydrochloride, and morphine. The prophylaxis of nausea and vomiting with dexamethasone 8 mg in the beginning of the anesthesia and the metoclopramide at the end of the surgery. During the anesthetic induction antibiotic prophylaxis (cefazolin 3 grams/day for 2 days) was administrated. The control group were submitted to the protocol of traditional fasting with at least 8 hours. Patients in this group received 1 to 2 liters of crystalloid fluid (ringer lactate) in the intraoperative, and they received 3 to 4 liters of crystalloid fluids (ringer lactate, saline 0.9% and/or dextrose 5%). In the immediate postoperative, 2 to 3 liters in the first day of postoperative and, finally, 1 to 2 liters in the second day of the postoperative. |
Who may qualify
- Ages
- 18 to 45 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 |
|---|---|---|
| ACERTO protocol vs Traditional careThree sample blood collections were performed, being one in the anesthesic induction and the others in the next 24 to 48 hours. The blood was sent to the laboratory for dosages of glucose, insulin, C-reactive protein, albumin, prealbumin, alpha 1 acid glycoprotein and interleukin 6. During the anesthesic induction we also collected blood for analize glycosylated hemoglobin. | Other | ACERTO, Traditional care |
Primary outcome
ACERTO protocol
Time frame: 6 months
To evaluate clinical results, insulin resistance and inflammatory response to trauma in morbidly obese patients undergoing laparoscopic Sleeve gastrectomy who received either traditional preoperative care or treatment following the ACERTO protocol.
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.
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 ACERTO protocol vs Traditional care in people with To Evaluate Clinical Results, Insulin Resistance and Inflammatory Response to Trauma in Morbidly Obese Patients, 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?
ACERTO protocol (time frame: 6 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.