Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000905066
Ethics application status
Approved
Date submitted
2/10/2010
Date registered
25/10/2010
Date last updated
25/10/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dental and nutritional issues in individuals submitted to Roux-en-Y gastric bypass surgery in a University Hospital.
Scientific title
The effect of Roux-en-Y bypass surgery on oral and nutritional issues in obese individuals with some form of associated co-morbidity
Secondary ID [1] 252811 0
Nil
Universal Trial Number (UTN)
U1111-1117-2356
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Morbid obesity 258316 0
Condition category
Condition code
Diet and Nutrition 258505 258505 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects were submitted to Y-en-Roux bypass surgery, also known as Capella or Fobi-Capella technique. It promotes gastrojejunal derivation, which is characterized by food restriction and malabsorption. A small gastric pouch is created while the jejunal ring portion is deviated. The remaining stomach is anastomosed in a distance of 75 to 150 cm from the gastric pouch, forming the Y-en-Roux bypass. The average duration of hospitalization was 4.5 days, while the average time of surgery was 3 h and the time of anesthesia was 3.5 h.
Intervention code [1] 257332 0
Treatment: Surgery
Comparator / control treatment
Active control: Control Group formed by normal-weight subjects who were not submitted to surgery.
Control group
Active

Outcomes
Primary outcome [1] 259341 0
Evaluate levels of markers involved in oxidative stress and
effect of weight loss after Roux-en-Y bypass surgery on energy and vitamin intake.

Tools: biochemical measurements. Blood was collected through a vacuum system in the cubital region, with the subjects fasting for 10 to 12 hours beforehand. When necessary, the samples were centrifuged to obtain serum for the measurement of vitamin C, beta-carotene, vitamin E levels, and MPO activity. Some samples were also collected with ethylenediaminetetraacetic acid (EDTA) to obtain plasma for the measurement of TBARS levels. After collection a whole blood fraction was immediately separated and precipitated with trichloroacetic acid (TCA) 12% (1:4, v:v) in cold vials, and stored in liquid nitrogen (minus 196 degrees C) until the analysis of GSH. Separation of red blood cells and plasma was performed by a rapid centrifugation (3000 g for 3 min at 5 degrees C) of whole blood, and the corresponding aliquots were immediately stored in liquid nitrogen until analysis. To obtain the hemolysates, red cells were washed twice with saline solution (NaCl, 95%), centrifuged (3000g for 3 min at 5 degrees C), and then two successive freeze-thaw procedures were performed to ensure complete cell lysis. A final centrifugation (5000g for 5 min at 5 degrees C) provided the hemolysate (1:9 w/v) supernatant for catalase evaluation in a buffer comprising 0.1% Triton X-100, 0.12 M NaCl, 30mM NaPO4 pH 7.4. All the samples were analyzed in duplicate and/ or triplicate, where appropriate. The reagents used were obtained from Sigma (St Louis, Mo, USA) and Merck (Sao Paulo, SP, Brazil).
Vitamin C The concentration of vitamin C was obtained through the colorimetric reaction with 2.4-di nitrophenylhydrazine and subsequent spectrophotometric reading at 520nm in a UV-VIS Q-108U spectrophotometer (Quimis Aparelhos Cientificos LTDA, Diadema, SP, Brazil). Results were expressed in microM.
Beta-carotene and vitamin E the concentrations of beta-carotene and vitamin E (alpha-tocopherol) were obtained by high performance liquid chromatography (HPLC) using a model 10AT VP apparatus (Shimadzu Co., Japan), with an ODS2 column (Spherisorb, 5 micro). A mobile phase of methanol/ dichloromethane/ acetonitrile (10:20:70) was used at a flow rate of 1mL/ min, with UV/VIS detection. Peaks for beta-carotene and alpha-tocopherol were noted at the wavelengths of 450nm and 292nm, respectively. Results were expressed in microM. Serum values for vitamin E were corrected according to Nagaya et al. The values for total cholesterol and triglycerides were determined using local commercial enzymatic kits: Colesterol Liquiform and Triglicerides Liquiform (Labtest Diagnostica S/A, Lagoa Santa, MG, Brazil) in a GBC UV-VIS spectrophotometer, model Q-108U (Quimis Aparelhos Cientificos Ltda., Diadema, SP, Brazil). Results were expressed in mg/dL.
Reduced glutathione (GSH) Concentrations of GSH (in fact non-protein small thiols) in whole blood were determined by the method described by Beutler, Duron & Kelly with Elman's reagent (dithionitrobenzoic acid, DTNB), at a wavelength of 412nm, in a GBC UV/VIS spectrophotometer, model 916 (Sydney, New South Wales, Australia). Results were expressed in micromol/mL.
Catalase (CAT) CAT was determined in hemolysates using the method described by Aebi. This assay quantifies the rate of decomposition of hydrogen peroxide due to the enzyme present in the sample, at 240 nm over 20 seconds, in a freshly prepared solution of 10 mM hydrogen peroxide, and results were expressed in mmol H2O2/min/mL.
Myeloperoxidase activity (MPO) Myeloperoxidase activity was measured according to the method developed by Rao et al and consi sting of a colorimetric assay at 450 nm using an ELISA reader (Organon Teknika, Roseland, NJ, USA). Results were expressed in mU/mL.
C-reactive Protein (CRP) Concentrations of the ultra-sensitive C-reactive protein were measured in serum through the nephelometry assay, according to instructions from the manufacturer (Dade Behring, Marburg, Germany). Results were expressed in mg/L.
Assessment of lipoperoxidation Lipoperoxidation was assessed in the plasma by measuring the levels of thiobarbituric acid reactive substances (TBARS), according to Ohkawa, Oshishi & Yagi and Bird & Draper. First, the plasma was precipitated by the addition of 12% trichloroacetic acid (TCA; 1 mL of 12% TCA per 100 microL of sample) followed by vigorous shaking for 5 seconds. Next, the sample was incubated for 60 minutes at 100 degrees C in the presence of 0.9 mL of 60 mM Tris-HCL buffer, pH 7.4 (0.1 mM DPTA) and 1mL of 0.73% thiobarbituric acid (TBA). After incubation, the material was chilled for 30 minutes at 5 degrees C, and later centrifuged. Samples were read at 535nm in a spectrophotometer. Results were expressed in nmol/mL.

Energy consumption in the control group refers to the normal daily consumption while that of the bariatric group refers to the period prior to surgery. The energy intake and vitamin C, beta-carotene and vitamin E intake were calculated from a validated semi-quantitative food frequency questionnaire and adjusted in relation to the total caloric value of the diet. The chemical and energy composition of the diet were obtained from food composition tables. In assessing the intake of the vitamins studied, supplementation was taken into account, since all of the patients were instructed to take 60 mg/ day of vitamin C, 3000 micrograms/ day of beta-carotene and 30mg/ day of vitamin E, provided in the form of a multivitamin and mineral supplement (Centrum Wyeth, Sao Paulo, SP, Brazil), as part of the post-surgery protocol of the hospital.
Timepoint [1] 259341 0
Timepoint: pre-surgical period (basal), and at 3, 6 12 and 24 months after surgery (experiment group). Control group was evaluated only once.
Primary outcome [2] 259460 0
Evaluate the oral cavity disease development.

Tools: Salivary Parameters: The saliva test included the saliva flow measurement and buffering capacity of the saliva. This test was performed in the basal period, and at 12 and 24 months after surgery using Dentobuff (Inodon, Porto Alegre, RS, Brazil). Before sampling, the patients were instructed to avoid eating, drinking and tooth brushing for 2 hours. During sampling, the patient was instructed to chew a piece of unflavoured paraffin, collecting the saliva in a suitable vessel. The salivary flow was calculated from the volume of saliva produced in 5 minutes, and was considered normal with a value equal or above 1mL/ minute. The buffering capacity was determined in 1.5 mL of saliva added to a tube containing a solution of 0.002 N chloridric acid and 4 drops of an indicator for colour. The colour obtained with the mixture was compared to the manufacturer's color chart of Dentobuff kit. The buffering capacity was expressed in numerical values and it was classified as following: (low salivary buffering capacity) pH < 4.5, (intermediate salivary buffering capacity) between 4.5 and 5.5 and (normal salivary buffering capacity) pH > 5.5.
Assessment of Oral Clinic Manifestation.
The oral assessment was carried out by the patient by means of an interview, according to criteria of the WHO. The structured questions used were validated and representative in the Project SB-2003-Ministry of Health (2004), Brazil. The symptoms presented and influence the oral health before and after surgery were: the presence of pain in the gums and teeth, bleeding of the gums (observing bleeding when brushing and/or eating hard, dry foods), presence of nausea, episodes of regurgitation and vomiting, dental sensitivity (thermal sensation of cold) and teeth with altered mobility were assessed by means of structured questions.
Timepoint [2] 259460 0
Timepoint: pre-surgical period (basal), and at 3, 6 12 and 24 months after surgery (experiment group). Control group was evaluated only once.
Secondary outcome [1] 266018 0
Nil
Timepoint [1] 266018 0
Nil

Eligibility
Key inclusion criteria
Experimental group: Inclusion criteria were: Body Mass Index: greater than or equal 40 or greater than 35 kg/ m^2 with some form of associated co-morbidity during the period.

Control group: Inclusion criteria were: the same age and gender as the experimental group (group submitted a Roux-en-Y bypass surgery), and Body Mass Index between 18.5 and 24.9 kg/ m^2 without associated co-morbidity during the period.
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Experimental group: exclusion criteria were psychological disorder; smoking; alcohol or drug dependency, and undergoing treatment with antibiotics and/or anti-inflammatory or immunosuppressant drugs.
Control group: exclusion criteria were the presence of diabetes, chronic or acute inflammatory disease, anemia, psychiatric disease, disorders in lipid metabolism, history of trauma, glucose intolerance, cardiovascular disease, ongoing treatment with antibiotics and/or anti-inflammatory or immunosuppressant drugs, alcohol or drug dependency, smoking, and current menstruation.

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)
Convenience sample.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment outside Australia
Country [1] 2948 0
Brazil
State/province [1] 2948 0
SC

Funding & Sponsors
Funding source category [1] 257771 0
Government body
Name [1] 257771 0
Fundacao de Apoio a Pesquisa Cientifica e Tecnologica do Estado de Santa Catarina (FAPESC)
Country [1] 257771 0
Brazil
Funding source category [2] 257772 0
Government body
Name [2] 257772 0
Conselho Nacional de Desenvolvimento Cientifico e Tecnologico (CNPq) by scholarship of Productivity in Research
Country [2] 257772 0
Brazil
Primary sponsor type
Individual
Name
Emilia Addison Machado Moreira
Address
Universidade Federal de Santa Catarina (UFSC). Campus Reitor Joao David Ferreira Lima - Trindade - Florianopolis - Santa Catarina -
ZIP 88040-970
Country
Brazil
Secondary sponsor category [1] 256983 0
Individual
Name [1] 256983 0
Tania Silvia Frode
Address [1] 256983 0
Universidade Federal de Santa Catarina (UFSC). Campus Reitor Joao David Ferreira Lima - Trindade - Florianopolis - Santa Catarina -
ZIP 88040-970
Country [1] 256983 0
Brazil
Other collaborator category [1] 251539 0
Individual
Name [1] 251539 0
Danilo Wilhelm Filho
Address [1] 251539 0
Universidade Federal de Santa Catarina (UFSC). Campus Reitor Joao David Ferreira Lima - Trindade - Florianopolis - Santa Catarina -
ZIP 88040-970
Country [1] 251539 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259813 0
Ethics Committee for Research with Humans of Federal University of Santa Catarina
Ethics committee address [1] 259813 0
Ethics committee country [1] 259813 0
Brazil
Date submitted for ethics approval [1] 259813 0
Approval date [1] 259813 0
30/10/2006
Ethics approval number [1] 259813 0
1/06/0072

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31731 0
Address 31731 0
Country 31731 0
Phone 31731 0
Fax 31731 0
Email 31731 0
Contact person for public queries
Name 14978 0
Emilia Addison Machado Moreira
Address 14978 0
Universidade Federal de Santa Catarina (UFSC). Campus Reitor Joao David Ferreira Lima - Trindade - Florianopolis - Santa Catarina - ZIP: 88040-970.
Country 14978 0
Brazil
Phone 14978 0
+55 (48) 3721-9784
Fax 14978 0
+55 (48) 3721-9542
Email 14978 0
[email protected]
Contact person for scientific queries
Name 5906 0
Emilia Addison Machado Moreira
Address 5906 0
Universidade Federal de Santa Catarina (UFSC). Campus Reitor Joao David Ferreira Lima - Trindade - Florianopolis - Santa Catarina - ZIP: 88040-970.
Country 5906 0
Brazil
Phone 5906 0
+55 (48) 3721-9784
Fax 5906 0
+55 (48) 3721-9542
Email 5906 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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