Sarcopenic ObesityEXPOBARNCT05289219
Effects of Physical Exercise on Sarcopenia After Bariatric Surgery
A study testing EXPOBAR in people with Sarcopenic Obesity and Bariatric Surgery Candidate, run by University of Évora at 2 sites in Portugal.
Trial summary
The study will include 60 patients awaiting bariatric surgery. They will be randomized into 2 groups, experimental and control. The intervention will take place 1 month after surgery, for a total of 16 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenic Obesity, Bariatric Surgery Candidate
- What is being tested?
- EXPOBAR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesPortugal
- Study dates
- 1 Sep 2021to Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- As inclusion criteria, patients should be enrolled for bariatric surgery at the hospital
- Aged between 18 years and 60 years
- Contraindication to the practice of exercise
- Agree to participate in the study
Who cannot join
- Patients with problems in locomotion
- Surgical complications
- Psychiatric diseases and neurological disorders
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites, 2 recruiting
- Recruiting
Cláudia Amaro dos Santos
Evora, 7000-758
Cláudia Amaro D Santos, 968575053 ext. +351, cmendes@hevora.min-saude.pt
Armando Raimundo, Ph.D
- Recruiting
Universidade de Évora
Evora
Cláudia Amaro Dos Santos, PhD Student, 968575053, cmendes@hevora.min-saude.pt
CRI.COM Centre
About this study
Official title: Effects of Physical Exercise on Sarcopenia After Bariatric Surgery: Protocol of a Randomized Controlled Study
The study will include 60 patients awaiting bariatric surgery. They will be randomized into 2 groups, experimental and control. The intervention will take place 1 month after surgery, for a total of 16 weeks. Parameters of body composition, metabolic risk, quality of life, physical activity and sedentary behavior will be determined
Read the detailed description
Bariatric surgery is the treatment of severe obesity with associated pathologies, with proven evidence in its benefits. Treating overweight allows a better and even reversal of pathologies associated with obesity. In this context, we know that physical exercise is important in the process of weight loss, however, and especially in bariatric surgery, the characteristics of physical activity are not consensual, as well as the effect of programs and physical exercise in this population. Weight loss associated with bariatric surgery is greatly associated with a significant reduction of skeletal muscle and bone mineral mass, which leads us to induce that after bariatric surgery, patients incur an increased risk of sarcopenia. The need for prophylactic programs that prevent sarcopenia in bariatric surgery patients seems to be one of the crucial points for the framing of long-term surgical success of bariatric and metabolic surgery. This randomized clinical trial will aim to study the effects of a 16-week supervised exercise intervention program on the prevention of sarcopenia after bariatric surgery This randomized controlled trial study will include 60 patients of both sexes on the waiting list for bariatric surgery and who have subsequently performed the surgery. They will be randomized into 2 groups, experimental and control. The intervention will take place 1 month after surgery, for a total of 16 weeks. Parameters of body composition, metabolic risk, quality of life, physical activity, and sedentary behavior will be determined.
Assessments will take place in five moments, the surgery, the intervention, the post-intervention, six months after the intervention, twelve months after the intervention.
- Conditions
- Sarcopenic Obesity, Bariatric Surgery Candidate
- Being tested
- EXPOBAR
- Keywords
- bariatric surgery, quality of life, metabolic risk factors,, fat-free mass, sarcopenia, exercise
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXPOBARBehavioural
Each session will start with 5 minutes of warm-up and finalization with 10 minutes of a cool-down, with work of flexibility and proprioception. The maintenance of balance and postural stability may be compromised in obese individuals, depending on the degree of obesity, although the support base provided by the position of the foot is proportional to the structural morphology of each subject. Flexibility is also gradually impaired in obese individuals and of course, these changes may be related to postural changes aggravated by a sedentary lifestyle and biological aging itself alongside all metabolic alterations inherent to the pathology of obesity (Benetti et al., 2016). And the warm-up and the cool-down will be developed as the component of training with the evolution by phases, both in time and in intensity. The first phase will include 20 minutes of interval training, encompassing circuit strength training. Each phase will have an increment of 10 minutes in the central block.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The duration of the program is 16-weeks, 3-times a week, for up to 50 minutes per session, starting 1 month after surgery, based on the recommendations of the WHO and the ACSM, because the guidelines for morbidly obese patients undergoing bariatric surgery are not defined. Information on exercises for morbidly obese adults is limited, so the exercise programs will follow the guidelines for adults aged 18 to 65 years healthy, with chronic diseases or disabilities Receives: Behavioral: EXPOBAR |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Weight evaluation will be done using a scale
Measured: 1 year
Height
Height evaluation will be done using a stadiometer
Measured: 1 year
Abdominal circumference
Abdominal circumference will be determined by a measuring tape
Measured: 1 year
HDL cholesterol in mg/dl
Blood sample
Measured: 1 year
LDL cholesterol in mg/dl
Blood sample
Measured: 1 year
Triglycerides in mg/dl
Blood sample
Measured: 1 year
Glucose in mg/dl
Blood sample
Measured: 1 year
Insulin in µIU/mL
Blood sample
Measured: 1 year
Glycated hemoglobin in %
Blood sample
Measured: 1 year
Alcohol intake
assessment of daily consumption through clinical data questionnaire
Measured: 1 year
Mean blood pressure
Evaluation with Sphygnomanonetro
Measured: 1 year
Concentration of ghrelin in pg/mg
blood ghrelin and leptin measurement
Measured: 1 year
Concentration of leptin in pg/mg
blood ghrelin and leptin measurement
Measured: 1 year
Lower limbs muscle strength
Lower limbs muscle strength will be evaluated with Biodex
Measured: 1 year
Upper limbs muscle strength
The muscle strength of the upper limbs will be evaluated by manual pressure dynamometry (Handgrip)
Measured: 1 year
Cardiorespiratory fitness
6-minute walk test (TC6)
Measured: 1 year
Cardiorespiratory
Sit-to-stand test for 30 seconds
Measured: 1 year
Secondary outcomes (4)
Life Quality
Questionary "BAROS" as a self-report measure, validated for the Portuguese population specific for bariatric surgery
Measured: 1 year
Salivary amylase
Saliva harvest
Measured: 1 year
physical activity level
Accelerometers measure body movement, providing objective information about the frequency, intensity and duration of physical activity
Measured: 1 year
Glycemia Variation in mg/dl
Evaluation continues through an implantable device for 5 days
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start1 Sep 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Sarcopenic 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Évora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cláudia Amaro dos Santos, University of Évora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289219
- Sponsor's protocol ID
- 21051
- Acronym
- EXPOBAR
- Status last verified
- Mar 2022
- First submitted
- 15 Feb 2022
- Last updated
- 21 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Baillot A, Mampuya WM, Comeau E, Meziat-Burdin A, Langlois MF. Feasibility and impacts of supervised exercise training in subjects with obesity awaiting bariatric surgery: a pilot study. Obes Surg. 2013 Jul;23(7):882-91. doi: 10.1007/s11695-013-0875-5.
PubMed 23430477Benetti FA, Bacha IL, Garrido Junior AB, Greve JM. Analyses of balance and flexibility of obese patients undergoing bariatric surgery. Clinics (Sao Paulo). 2016 Feb;71(2):78-81. doi: 10.6061/clinics/2016(02)05.
PubMed 26934236Broughton DE, Moley KH. Obesity and female infertility: potential mediators of obesity's impact. Fertil Steril. 2017 Apr;107(4):840-847. doi: 10.1016/j.fertnstert.2017.01.017. Epub 2017 Mar 11.
PubMed 28292619Campbell WW, Kraus WE, Powell KE, Haskell WL, Janz KF, Jakicic JM, Troiano RP, Sprow K, Torres A, Piercy KL, Bartlett DB; 2018 PHYSICAL ACTIVITY GUIDELINES ADVISORY COMMITTEE*. High-Intensity Interval Training for Cardiometabolic Disease Prevention. Med Sci Sports Exerc. 2019 Jun;51(6):1220-1226. doi: 10.1249/MSS.0000000000001934.
PubMed 31095079Castello V, Simoes RP, Bassi D, Catai AM, Arena R, Borghi-Silva A. Impact of aerobic exercise training on heart rate variability and functional capacity in obese women after gastric bypass surgery. Obes Surg. 2011 Nov;21(11):1739-49. doi: 10.1007/s11695-010-0319-4.
PubMed 21104041Hanvold SE, Vinknes KJ, Loken EB, Hjartaker A, Klungsoyr O, Birkeland E, Risstad H, Gulseth HL, Refsum H, Aas AM. Does Lifestyle Intervention After Gastric Bypass Surgery Prevent Weight Regain? A Randomized Clinical Trial. Obes Surg. 2019 Nov;29(11):3419-3431. doi: 10.1007/s11695-019-04109-7.
PubMed 31363961Herring LY, Stevinson C, Carter P, Biddle SJH, Bowrey D, Sutton C, Davies MJ. The effects of supervised exercise training 12-24 months after bariatric surgery on physical function and body composition: a randomised controlled trial. Int J Obes (Lond). 2017 Jun;41(6):909-916. doi: 10.1038/ijo.2017.60. Epub 2017 Mar 6.
PubMed 28262676Jassil FC, Carnemolla A, Kingett H, Paton B, O'Keeffe AG, Doyle J, Morris S, Lewis N, Kirk A, Pucci A, Chaiyasoot K, Batterham RL. Protocol for a 1-year prospective, longitudinal cohort study of patients undergoing Roux-en-Y gastric bypass and sleeve gastrectomy: the BARI-LIFESTYLE observational study. BMJ Open. 2018 Mar 16;8(3):e020659. doi: 10.1136/bmjopen-2017-020659.
PubMed 29549212Kalinowski P, Paluszkiewicz R, Wroblewski T, Remiszewski P, Grodzicki M, Bartoszewicz Z, Krawczyk M. Ghrelin, leptin, and glycemic control after sleeve gastrectomy versus Roux-en-Y gastric bypass-results of a randomized clinical trial. Surg Obes Relat Dis. 2017 Feb;13(2):181-188. doi: 10.1016/j.soard.2016.08.025. Epub 2016 Aug 18.
PubMed 27692906de Oliveira LF, Tisott CG, Silvano DM, Campos CM, do Nascimento RR. GLYCEMIC BEHAVIOR IN 48 HOURS POSTOPERATIVE PERIOD OF PATIENTS WITH TYPE 2 DIABETES MELLITUS AND NON DIABETIC SUBMITTED TO BARIATRIC SURGERY. Arq Bras Cir Dig. 2015;28 Suppl 1(Suppl 1):26-30. doi: 10.1590/S0102-6720201500S100009.
PubMed 26537269Pekar M, Pekarova A, Buzga M, Holeczy P, Soltes M. The risk of sarcopenia 24 months after bariatric surgery - assessment by dual energy X-ray absorptiometry (DEXA): a prospective study. Wideochir Inne Tech Maloinwazyjne. 2020 Dec;15(4):583-587. doi: 10.5114/wiitm.2020.93463. Epub 2020 Mar 4.
PubMed 33294073Petta S, Ciminnisi S, Di Marco V, Cabibi D, Camma C, Licata A, Marchesini G, Craxi A. Sarcopenia is associated with severe liver fibrosis in patients with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2017 Feb;45(4):510-518. doi: 10.1111/apt.13889. Epub 2016 Dec 27.
PubMed 28028821Soriano-Maldonado A, Martinez-Forte S, Ferrer-Marquez M, Martinez-Rosales E, Hernandez-Martinez A, Carretero-Ruiz A, Villa-Gonzalez E, Barranco-Ruiz Y, Rodriguez-Perez MA, Torrente-Sanchez MJ, Carmona-Rodriguez L, Soriano-Maldonado P, Vargas-Hitos JA, Casimiro-Andujar AJ, Artero EG, Fernandez-Alonso AM. Physical Exercise following bariatric surgery in women with Morbid obesity: Study protocol clinical trial (SPIRIT compliant). Medicine (Baltimore). 2020 Mar;99(12):e19427. doi: 10.1097/MD.0000000000019427.
PubMed 32195937Villa-Gonzalez E, Barranco-Ruiz Y, Rodriguez-Perez MA, Carretero-Ruiz A, Garcia-Martinez JM, Hernandez-Martinez A, Torrente-Sanchez MJ, Ferrer-Marquez M, Soriano-Maldonado A, Artero EG; EFIBAR Study Group. Supervised exercise following bariatric surgery in morbid obese adults: CERT-based exercise study protocol of the EFIBAR randomised controlled trial. BMC Surg. 2019 Sep 5;19(1):127. doi: 10.1186/s12893-019-0566-9.
PubMed 31488115Voican CS, Lebrun A, Maitre S, Lainas P, Lamouri K, Njike-Nakseu M, Gaillard M, Tranchart H, Balian A, Dagher I, Perlemuter G, Naveau S. Predictive score of sarcopenia occurrence one year after bariatric surgery in severely obese patients. PLoS One. 2018 May 14;13(5):e0197248. doi: 10.1371/journal.pone.0197248. eCollection 2018.
PubMed 29758061
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Exercise on Sarcopenia After Bariatric Surgery: Protocol of a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05289219
- Acronym / sponsor ID
- EXPOBAR / 21051
- Conditions
- Sarcopenic Obesity, Bariatric Surgery Candidate
- Keywords
- bariatric surgery, quality of life, metabolic risk factors,, fat-free mass, sarcopenia, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ÉvoraUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 21 Mar 2022 (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.
The study will include 60 patients awaiting bariatric surgery. They will be randomized into 2 groups, experimental and control. The intervention will take place 1 month after surgery, for a total of 16 weeks. Parameters of body composition, metabolic risk, quality of life, physical activity and sedentary behavior will be determined
Detailed description
Bariatric surgery is the treatment of severe obesity with associated pathologies, with proven evidence in its benefits. Treating overweight allows a better and even reversal of pathologies associated with obesity. In this context, we know that physical exercise is important in the process of weight loss, however, and especially in bariatric surgery, the characteristics of physical activity are not consensual, as well as the effect of programs and physical exercise in this population. Weight loss associated with bariatric surgery is greatly associated with a significant reduction of skeletal muscle and bone mineral mass, which leads us to induce that after bariatric surgery, patients incur an increased risk of sarcopenia. The need for prophylactic programs that prevent sarcopenia in bariatric surgery patients seems to be one of the crucial points for the framing of long-term surgical success of bariatric and metabolic surgery. This randomized clinical trial will aim to study the effects of a 16-week supervised exercise intervention program on the prevention of sarcopenia after bariatric surgery This randomized controlled trial study will include 60 patients of both sexes on the waiting list for bariatric surgery and who have subsequently performed the surgery. They will be randomized into 2 groups, experimental and control. The intervention will take place 1 month after surgery, for a total of 16 weeks. Parameters of body composition, metabolic risk, quality of life, physical activity, and sedentary behavior will be determined.
Assessments will take place in five moments, the surgery, the intervention, the post-intervention, six months after the intervention, twelve months after the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: EXPOBARThe duration of the program is 16-weeks, 3-times a week, for up to 50 minutes per session, starting 1 month after surgery, based on the recommendations of the WHO and the ACSM, because the guidelines for morbidly obese patients undergoing bariatric surgery are not defined. Information on exercises for morbidly obese adults is limited, so the exercise programs will follow the guidelines for adults aged 18 to 65 years healthy, with chronic diseases or disabilities |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- As inclusion criteria, patients should be enrolled for bariatric surgery at the hospital
- Aged between 18 years and 60 years
- Contraindication to the practice of exercise
- Agree to participate in the study
Key exclusion criteria (3 listed)
- Patients with problems in locomotion
- Surgical complications
- Psychiatric diseases and neurological disorders
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 |
|---|---|---|
| EXPOBAREach session will start with 5 minutes of warm-up and finalization with 10 minutes of a cool-down, with work of flexibility and proprioception. The maintenance of balance and postural stability may be compromised in obese individuals, depending on the degree of obesity, although the support base provided by the position of the foot is proportional to the structural morphology of each subject. Flexibility is also gradually impaired in obese individuals and of course, these changes may be related to postural changes aggravated by a sedentary lifestyle and biological aging itself alongside all metabolic alterations inherent to the pathology of obesity (Benetti et al., 2016). And the warm-up and the cool-down will be developed as the component of training with the evolution by phases, both in time and in intensity. The first phase will include 20 minutes of interval training, encompassing circuit strength training. Each phase will have an increment of 10 minutes in the central block. | Behavioural | Intervention Group |
Primary outcome
Body weight
Time frame: 1 year
Weight evaluation will be done using a scale
Height
Time frame: 1 year
Height evaluation will be done using a stadiometer
Abdominal circumference
Time frame: 1 year
Abdominal circumference will be determined by a measuring tape
HDL cholesterol in mg/dl
Time frame: 1 year
Blood sample
LDL cholesterol in mg/dl
Time frame: 1 year
Blood sample
Triglycerides in mg/dl
Time frame: 1 year
Blood sample
Glucose in mg/dl
Time frame: 1 year
Blood sample
Insulin in µIU/mL
Time frame: 1 year
Blood sample
Glycated hemoglobin in %
Time frame: 1 year
Blood sample
Alcohol intake
Time frame: 1 year
assessment of daily consumption through clinical data questionnaire
Mean blood pressure
Time frame: 1 year
Evaluation with Sphygnomanonetro
Concentration of ghrelin in pg/mg
Time frame: 1 year
blood ghrelin and leptin measurement
Concentration of leptin in pg/mg
Time frame: 1 year
blood ghrelin and leptin measurement
Lower limbs muscle strength
Time frame: 1 year
Lower limbs muscle strength will be evaluated with Biodex
Upper limbs muscle strength
Time frame: 1 year
The muscle strength of the upper limbs will be evaluated by manual pressure dynamometry (Handgrip)
Cardiorespiratory fitness
Time frame: 1 year
6-minute walk test (TC6)
Cardiorespiratory
Time frame: 1 year
Sit-to-stand test for 30 seconds
4 secondary outcomes
Life Quality
Time frame: 1 year
Salivary amylase
Time frame: 1 year
physical activity level
Time frame: 1 year
Glycemia Variation in mg/dl
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Background: PubMed 23430477Baillot A, Mampuya WM, Comeau E, Meziat-Burdin A, Langlois MF. Feasibility and impacts of supervised exercise training in subjects with obesity awaiting bariatric surgery: a pilot study. Obes Surg. 2013 Jul;23(7):882-91. doi: 10.1007/s11695-013-0875-5.
- Background: PubMed 26934236Benetti FA, Bacha IL, Garrido Junior AB, Greve JM. Analyses of balance and flexibility of obese patients undergoing bariatric surgery. Clinics (Sao Paulo). 2016 Feb;71(2):78-81. doi: 10.6061/clinics/2016(02)05.
- Background: PubMed 28292619Broughton DE, Moley KH. Obesity and female infertility: potential mediators of obesity's impact. Fertil Steril. 2017 Apr;107(4):840-847. doi: 10.1016/j.fertnstert.2017.01.017. Epub 2017 Mar 11.
- Background: PubMed 31095079Campbell WW, Kraus WE, Powell KE, Haskell WL, Janz KF, Jakicic JM, Troiano RP, Sprow K, Torres A, Piercy KL, Bartlett DB; 2018 PHYSICAL ACTIVITY GUIDELINES ADVISORY COMMITTEE*. High-Intensity Interval Training for Cardiometabolic Disease Prevention. Med Sci Sports Exerc. 2019 Jun;51(6):1220-1226. doi: 10.1249/MSS.0000000000001934.
- Background: PubMed 21104041Castello V, Simoes RP, Bassi D, Catai AM, Arena R, Borghi-Silva A. Impact of aerobic exercise training on heart rate variability and functional capacity in obese women after gastric bypass surgery. Obes Surg. 2011 Nov;21(11):1739-49. doi: 10.1007/s11695-010-0319-4.
- Background: PubMed 31363961Hanvold SE, Vinknes KJ, Loken EB, Hjartaker A, Klungsoyr O, Birkeland E, Risstad H, Gulseth HL, Refsum H, Aas AM. Does Lifestyle Intervention After Gastric Bypass Surgery Prevent Weight Regain? A Randomized Clinical Trial. Obes Surg. 2019 Nov;29(11):3419-3431. doi: 10.1007/s11695-019-04109-7.
- Background: PubMed 28262676Herring LY, Stevinson C, Carter P, Biddle SJH, Bowrey D, Sutton C, Davies MJ. The effects of supervised exercise training 12-24 months after bariatric surgery on physical function and body composition: a randomised controlled trial. Int J Obes (Lond). 2017 Jun;41(6):909-916. doi: 10.1038/ijo.2017.60. Epub 2017 Mar 6.
- Background: PubMed 29549212Jassil FC, Carnemolla A, Kingett H, Paton B, O'Keeffe AG, Doyle J, Morris S, Lewis N, Kirk A, Pucci A, Chaiyasoot K, Batterham RL. Protocol for a 1-year prospective, longitudinal cohort study of patients undergoing Roux-en-Y gastric bypass and sleeve gastrectomy: the BARI-LIFESTYLE observational study. BMJ Open. 2018 Mar 16;8(3):e020659. doi: 10.1136/bmjopen-2017-020659.
- Background: PubMed 27692906Kalinowski P, Paluszkiewicz R, Wroblewski T, Remiszewski P, Grodzicki M, Bartoszewicz Z, Krawczyk M. Ghrelin, leptin, and glycemic control after sleeve gastrectomy versus Roux-en-Y gastric bypass-results of a randomized clinical trial. Surg Obes Relat Dis. 2017 Feb;13(2):181-188. doi: 10.1016/j.soard.2016.08.025. Epub 2016 Aug 18.
- Background: PubMed 26537269de Oliveira LF, Tisott CG, Silvano DM, Campos CM, do Nascimento RR. GLYCEMIC BEHAVIOR IN 48 HOURS POSTOPERATIVE PERIOD OF PATIENTS WITH TYPE 2 DIABETES MELLITUS AND NON DIABETIC SUBMITTED TO BARIATRIC SURGERY. Arq Bras Cir Dig. 2015;28 Suppl 1(Suppl 1):26-30. doi: 10.1590/S0102-6720201500S100009.
- Background: PubMed 33294073Pekar M, Pekarova A, Buzga M, Holeczy P, Soltes M. The risk of sarcopenia 24 months after bariatric surgery - assessment by dual energy X-ray absorptiometry (DEXA): a prospective study. Wideochir Inne Tech Maloinwazyjne. 2020 Dec;15(4):583-587. doi: 10.5114/wiitm.2020.93463. Epub 2020 Mar 4.
- Background: PubMed 28028821Petta S, Ciminnisi S, Di Marco V, Cabibi D, Camma C, Licata A, Marchesini G, Craxi A. Sarcopenia is associated with severe liver fibrosis in patients with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2017 Feb;45(4):510-518. doi: 10.1111/apt.13889. Epub 2016 Dec 27.
- Individual participant dataSharing planned: Undecided
Related trials for Sarcopenic Obesity
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
Active, not recruitingObservational study
Dietary Intake, Sarcopenic Obesity, and Other Treatment-Related Outcomes in Indian Children With Acute Lymphoblastic Leukemia
Sarcopenic Obesity
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity
Not yet recruiting
Effects of the EatWelLog App on Enhancing Diet Management for Older Adults With Sarcopenic Obesity
Sacropenic Obesity
RecruitingObservational study
GLP-1 Receptor Agonist Use and Sarcopenia in Obese Individuals Without Diabetes
Obesity, Sarcopenia
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXPOBAR in people with Sarcopenic Obesity and Bariatric Surgery Candidate, run by University of Évora at 2 sites in Portugal.
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 4 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: status not confirmed, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. 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 Cláudia Amaro Dos Santos, PhD Student (968575053 ext. +351, cmendes@hevora.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 1 year). The study lists 17 primary outcomes in all. 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 NCT05289219, which also lists 18 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 21 Mar 2022.