ObesityRYGBPNCT02422212
Diet-induced Thermogenesis in Patients With Postoperative Roux-in-Y Gastric Bypass (RYGBP) Weight Regain
A study testing patients eat a mixed solid meal in people with Obesity and Bariatric Surgery Candidate, run by Silvia Leite Faria at 3 sites in Brazil.
Trial summary
Introduction: According to the National Health and Nutrition Examination Survey 2009-2010, 78 million American adults are obese. Bariatric surgery can provide for a sustained long-term weight loss and the metabolic change caused by the surgery seems to be the main cause of this loss. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Obesity, Bariatric Surgery Candidate, Protein-energy; Imbalance
- What is being tested?
- patients eat a mixed solid meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesBrazil
- Study dates
- Jan 2014to Apr 2015
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bariatric patients (those who had done Roux-en-Y Gastric Bypass) who have more than 2 years of surgery with healthy weight and also those with weight regain
- Obese population in pre operative phase of bariatric surgery
Who cannot join
- Patients if male sex,
- pregnant or breastfeeding patients,
- patients with more than 5 years of surgery
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Gastrocirurgia de Brasilia
Brasília, Federal District, 70390-108
Gastrocirurgia de Brasilia
Brasília, Federal District, 70390108
Gastrocirurgia
Brasília, Federal District, 70390108
About this study
Official title: Diet-induced Thermogenesis in Patients With Postoperative RYGBP Weight Regain
Introduction: According to the National Health and Nutrition Examination Survey 2009-2010, 78 million American adults are obese. Bariatric surgery can provide for a sustained long-term weight loss and the metabolic change caused by the surgery seems to be the main cause of this loss. Cross-sectional, prospective and experimental studies, carried out during the post-operative period of Roux-en-Y Gastric Bypass surgery (RYGBP) have shown an increase of over 200% in energy expenditure after meals Diet-induced Thermogenesis (DIT), a specific component of energy expenditure) when compared with obese patients. However, despite this metabolic improvement, 20-50% of the patients can suffer weight regain about 2 years after surgery. So one question whether such metabolic benefits remain active following post-operative weight regain, or if the disappearance or decrease of these metabolic benefits may be seen as causes of this weight regain.
Objective:To evaluate whether there are DIT differences between patients who maintained weight loss and those who regained weight in the late postoperative (postop) period of RYGBP and those who continue with preoperative (preop) obesity.
Read the detailed description
Methods: This cross-sectional study evaluated three female groups: 1) Postop RYGBP patients operated at least 2 years previously, with healthy weight (at least 50% loss of excess weight) - HW group ; 2) Clinically severe obese patients (BMI > 40 kg/m2, without co-morbidities or > 35 kg/m2 with co-morbidities) - OB group; 3) Post-op RYGBP WR patients (at least 10% above post-op minimum weight and less than 50% loss of preop excess weight) - WR group. All patients, from a private practice in Brasilia, were given indirect calorimetry examinations (GERATHERM RESPIRATORY®) measuring resting metabolic rate (RMR), respiratory exchange rate (RER) and DIT and collected urine during 24 hours for analysis. Immediately after RMR measurement, a solid mixed meal was served (270 kcal: 62% carbohydrate, 12% protein and 26% lipid). Remove? After ten minutes, successive PP energy expenditure measurements were taken (after some minutes, viz): 10-20, 20-30, 30-40, 60-70, 70-80, 80-90, 110-120, 120- 130, 130-140, 160-170 and 170-180, accompanying a 3-hour measurement period. DIT, calculated for each interval, followed this equation: DIT = PP Metabolic rate (MR) time interval - RMR. Correct? Mean areas under the curve (AUC) of all groups and baseline time measurements were compared using the analysis of variance test (ANOVA). Between-group longitudinal changes were tested using a mixed-effects model analysis of variance for repeated measures. Showing a p-value < 0.05, a Bonferroni correction was used. AUC was calculated by trapezoidal rule, considering significant a value of p <0.05.
Results: 45 patients participated (HW 21, OB 13, WR 11). Mean group age was 37.00 ± 6.98 years , 38.72 ± 7.01 years, and 37.88 ± 6.39 years, respectively. I changed the sequence to match the original. RER values increased significantly in all groups from baseline until final measurements. Metabolic rate (MR) adjusted for body weight (BW-adjusted MR (MR/kg)?) was not significant in the OB group at any PP moment compared to baseline. The HW and WR groups showed significant increase until final measurements. Mean AUC values for RER and RMR in absolute terms did not differ between groups (p = 0.3111 and p = 0.1131, respectively). (Two p values for how many groups ? 2 or 3?) Mean AUC values for BW-adjusted MR (kcal/kg)? differed between groups, where the average AUC value was significantly greater in the HW group than in the WR and the OB groups (p <0.0001 for both). Mean AUC value for BW-adjusted MR in the WR group was not significantly different from the OB group (p = 0.6369).
- Being tested
- patients eat a mixed solid meal
- Keywords
- metabolism, Diet Induced Thermogenesis, weight regain, energy expenditure, bariatric
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients eat a mixed solid mealOther
The three groups were given an indirect calorimetry examination to measure their resting metabolic rate (RMR), respiratory exchange rate (RER) and DIT. The patients collected urine during 24 hours for urinary nitrogen analysis. Immediately after the RMR measurement, patients received a solid mixed meal (270 kcal, with 62% carbohydrate, 12% protein and 26% lipid). Ten minutes after beginning this food intake, postprandial (PP) energy expenditure measurements were taken in the following sequences (in minutes): 10-20, 20-30, 30-40, 60-70, 70-80, 80-90, 110-120, 120- 130, 130-140, 160-170 and 170-180.The DIT was calculated for each time interval.
| Study group | Role | What they receive |
|---|---|---|
| healthy weight group | Active comparator | Postop RYGBP patients who underwent surgery at least 2 years previously and have healthy weight (at least 50% loss of excess weight) (HW group) Intervention: Immediately after RMR measurement, a solid mixed meal was served (270 kcal: 62% carbohydrate, 12% protein and 26% lipid) Receives: Other: patients eat a mixed solid meal |
| Obese group | Other | Clinically severe obese patients (Body Mass Index greater than 40 kg/m2, without co-morbidities and greater than 35 kg/m2 with co-morbidities) (OB group) Intervention: Immediately after RMR measurement, a solid mixed meal was served (270 kcal: 62% carbohydrate, 12% protein and 26% lipid) Receives: Other: patients eat a mixed solid meal |
| weight regain group | Active comparator | Patients who suffered weight regain after RYGBP (at least 10% above the minimum weight after surgery and less than 50% loss of preop excess weight) (WR group) Intervention: Immediately after RMR measurement, a solid mixed meal was served (270 kcal: 62% carbohydrate, 12% protein and 26% lipid) Receives: Other: patients eat a mixed solid meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Diet Induced thermogenesis
The three groups were given an indirect calorimetry examination (GERATHERM RESPIRATORY®) to measure their resting metabolic rate (RMR), respiratory exchange rate (RER) and DIT. To assure proper measurement of RER, the patients collected urine during 24 hours for urinary nitrogen analysis. Immediately after the RMR measurement, patients received a solid mixed meal of 270 kcal, which was 62% carbohydrate, 12% protein and 26% lipid. Ten minutes after beginning this food intake, postprandial (PP) energy expenditure measurements were taken in the following sequences (in minutes): 10-20, 20-30, 30-40, 60-70, 70-80, 80-90, 110-120, 120- 130, 130-140, 160-170 and 170-180. In this way, a PP-time period of 3 hours was accompanied. The DIT was calculated for each time interval, based on the following equation: DIT = Metabolic rate (MR) PP time interval as X - RMR.
Measured: 180 minuts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silvia Leite Faria
- Sponsor type
- University, hospital or other
- Collaborators
- University of Brasilia
- Responsible party
- Sponsor-investigator, Silvia Leite Faria, Gastrocirurgia, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422212
- Sponsor's protocol ID
- 05
- Acronym
- RYGBP
- Status last verified
- Apr 2015
- First submitted
- 9 Apr 2015
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Faria SL, Faria OP, Cardeal Mde A, Ito MK, Buffington C. Diet-induced thermogenesis and respiratory quotient after Roux-en-Y gastric bypass surgery: a prospective study. Surg Obes Relat Dis. 2014 Jan-Feb;10(1):138-43. doi: 10.1016/j.soard.2013.09.020. Epub 2013 Oct 10.
PubMed 24507080Faria SL, Faria OP, Cardeal Mde A, de Gouvea HR, Buffington C. Diet-induced thermogenesis and respiratory quotient after Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2012 Nov-Dec;8(6):797-802. doi: 10.1016/j.soard.2012.06.008. Epub 2012 Jul 23.
PubMed 22884301Stylopoulos N, Hoppin AG, Kaplan LM. Roux-en-Y gastric bypass enhances energy expenditure and extends lifespan in diet-induced obese rats. Obesity (Silver Spring). 2009 Oct;17(10):1839-47. doi: 10.1038/oby.2009.207. Epub 2009 Jun 25.
PubMed 19556976
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet-induced Thermogenesis in Patients With Postoperative RYGBP Weight Regain
- ClinicalTrials.gov ID
- NCT02422212
- Acronym / sponsor ID
- RYGBP / 05
- Keywords
- metabolism, Diet Induced Thermogenesis, weight regain, energy expenditure, bariatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Silvia Leite FariaUniversity, hospital or other
- Collaborators
- University of Brasilia
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 21 Apr 2015 (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.
Introduction: According to the National Health and Nutrition Examination Survey 2009-2010, 78 million American adults are obese. Bariatric surgery can provide for a sustained long-term weight loss and the metabolic change caused by the surgery seems to be the main cause of this loss. Cross-sectional, prospective and experimental studies, carried out during the post-operative period of Roux-en-Y Gastric Bypass surgery (RYGBP) have shown an increase of over 200% in energy expenditure after meals Diet-induced Thermogenesis (DIT), a specific component of energy expenditure) when compared with obese patients. However, despite this metabolic improvement, 20-50% of the patients can suffer weight regain about 2 years after surgery. So one question whether such metabolic benefits remain active following post-operative weight regain, or if the disappearance or decrease of these metabolic benefits may be seen as causes of this weight regain.
Objective:To evaluate whether there are DIT differences between patients who maintained weight loss and those who regained weight in the late postoperative (postop) period of RYGBP and those who continue with preoperative (preop) obesity.
Detailed description
Methods: This cross-sectional study evaluated three female groups: 1) Postop RYGBP patients operated at least 2 years previously, with healthy weight (at least 50% loss of excess weight) - HW group ; 2) Clinically severe obese patients (BMI > 40 kg/m2, without co-morbidities or > 35 kg/m2 with co-morbidities) - OB group; 3) Post-op RYGBP WR patients (at least 10% above post-op minimum weight and less than 50% loss of preop excess weight) - WR group. All patients, from a private practice in Brasilia, were given indirect calorimetry examinations (GERATHERM RESPIRATORY®) measuring resting metabolic rate (RMR), respiratory exchange rate (RER) and DIT and collected urine during 24 hours for analysis. Immediately after RMR measurement, a solid mixed meal was served (270 kcal: 62% carbohydrate, 12% protein and 26% lipid). Remove? After ten minutes, successive PP energy expenditure measurements were taken (after some minutes, viz): 10-20, 20-30, 30-40, 60-70, 70-80, 80-90, 110-120, 120- 130, 130-140, 160-170 and 170-180, accompanying a 3-hour measurement period. DIT, calculated for each interval, followed this equation: DIT = PP Metabolic rate (MR) time interval - RMR. Correct? Mean areas under the curve (AUC) of all groups and baseline time measurements were compared using the analysis of variance test (ANOVA). Between-group longitudinal changes were tested using a mixed-effects model analysis of variance for repeated measures. Showing a p-value < 0.05, a Bonferroni correction was used. AUC was calculated by trapezoidal rule, considering significant a value of p <0.05.
Results: 45 patients participated (HW 21, OB 13, WR 11). Mean group age was 37.00 ± 6.98 years , 38.72 ± 7.01 years, and 37.88 ± 6.39 years, respectively. I changed the sequence to match the original. RER values increased significantly in all groups from baseline until final measurements. Metabolic rate (MR) adjusted for body weight (BW-adjusted MR (MR/kg)?) was not significant in the OB group at any PP moment compared to baseline. The HW and WR groups showed significant increase until final measurements. Mean AUC values for RER and RMR in absolute terms did not differ between groups (p = 0.3111 and p = 0.1131, respectively). (Two p values for how many groups ? 2 or 3?) Mean AUC values for BW-adjusted MR (kcal/kg)? differed between groups, where the average AUC value was significantly greater in the HW group than in the WR and the OB groups (p <0.0001 for both). Mean AUC value for BW-adjusted MR in the WR group was not significantly different from the OB group (p = 0.6369).
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy weight group | Active comparator | Other: patients eat a mixed solid mealPostop RYGBP patients who underwent surgery at least 2 years previously and have healthy weight (at least 50% loss of excess weight) (HW group) Intervention: Immediately after RMR measurement, a solid mixed meal was served (270 kcal: 62% carbohydrate, 12% protein and 26% lipid) |
| Obese group | Other | Other: patients eat a mixed solid mealClinically severe obese patients (Body Mass Index greater than 40 kg/m2, without co-morbidities and greater than 35 kg/m2 with co-morbidities) (OB group) Intervention: Immediately after RMR measurement, a solid mixed meal was served (270 kcal: 62% carbohydrate, 12% protein and 26% lipid) |
| weight regain group | Active comparator | Other: patients eat a mixed solid mealPatients who suffered weight regain after RYGBP (at least 10% above the minimum weight after surgery and less than 50% loss of preop excess weight) (WR group) Intervention: Immediately after RMR measurement, a solid mixed meal was served (270 kcal: 62% carbohydrate, 12% protein and 26% lipid) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Bariatric patients (those who had done Roux-en-Y Gastric Bypass) who have more than 2 years of surgery with healthy weight and also those with weight regain
- Obese population in pre operative phase of bariatric surgery
Key exclusion criteria (3 listed)
- Patients if male sex,
- pregnant or breastfeeding patients,
- patients with more than 5 years of surgery
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 |
|---|---|---|
| patients eat a mixed solid mealThe three groups were given an indirect calorimetry examination to measure their resting metabolic rate (RMR), respiratory exchange rate (RER) and DIT. The patients collected urine during 24 hours for urinary nitrogen analysis. Immediately after the RMR measurement, patients received a solid mixed meal (270 kcal, with 62% carbohydrate, 12% protein and 26% lipid). Ten minutes after beginning this food intake, postprandial (PP) energy expenditure measurements were taken in the following sequences (in minutes): 10-20, 20-30, 30-40, 60-70, 70-80, 80-90, 110-120, 120- 130, 130-140, 160-170 and 170-180.The DIT was calculated for each time interval. | Other | Obese group, healthy weight group, weight regain group |
Primary outcome
Measurement of Diet Induced thermogenesis
Time frame: 180 minuts
The three groups were given an indirect calorimetry examination (GERATHERM RESPIRATORY®) to measure their resting metabolic rate (RMR), respiratory exchange rate (RER) and DIT. To assure proper measurement of RER, the patients collected urine during 24 hours for urinary nitrogen analysis. Immediately after the RMR measurement, patients received a solid mixed meal of 270 kcal, which was 62% carbohydrate, 12% protein and 26% lipid. Ten minutes after beginning this food intake, postprandial (PP) energy expenditure measurements were taken in the following sequences (in minutes): 10-20, 20-30, 30-40, 60-70, 70-80, 80-90, 110-120, 120- 130, 130-140, 160-170 and 170-180. In this way, a PP-time period of 3 hours was accompanied. The DIT was calculated for each time interval, based on the following equation: DIT = Metabolic rate (MR) PP time interval as X - RMR.
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 23 Apr 2015.
- Background: PubMed 24507080Faria SL, Faria OP, Cardeal Mde A, Ito MK, Buffington C. Diet-induced thermogenesis and respiratory quotient after Roux-en-Y gastric bypass surgery: a prospective study. Surg Obes Relat Dis. 2014 Jan-Feb;10(1):138-43. doi: 10.1016/j.soard.2013.09.020. Epub 2013 Oct 10.
- Background: PubMed 22884301Faria SL, Faria OP, Cardeal Mde A, de Gouvea HR, Buffington C. Diet-induced thermogenesis and respiratory quotient after Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2012 Nov-Dec;8(6):797-802. doi: 10.1016/j.soard.2012.06.008. Epub 2012 Jul 23.
- Background: PubMed 19556976Stylopoulos N, Hoppin AG, Kaplan LM. Roux-en-Y gastric bypass enhances energy expenditure and extends lifespan in diet-induced obese rats. Obesity (Silver Spring). 2009 Oct;17(10):1839-47. doi: 10.1038/oby.2009.207. Epub 2009 Jun 25.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patients eat a mixed solid meal in people with Obesity and Bariatric Surgery Candidate, run by Silvia Leite Faria at 3 sites in Brazil.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Measurement of Diet Induced thermogenesis (time frame: 180 minuts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02422212, which also lists 3 linked publications.
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 23 Apr 2015.