Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| McGill University Health Centre/Research Institute of the McGill University Health Centre | OTHER |
Not provided
Not provided
Not provided
Not provided
Background: Bariatric surgery is gaining in popularity. While it's health benefits are undisputed, the older malabsorptive bariatric procedures (Roux-in-Y gastric bypass - RYGB and biliopancreatic diversion - BPD) are associated with an increased risk of fractures and falls as early as 3-5 years after surgery. Sleeve gastrectomy - SG is now the most performed bariatric procedure. Although SG does not cause malabsorption, it is predicted to result in bone and muscle loss via weight loss and weight loss-independent mechanisms. Primary aim: to compare the changes in spine volumetric bone mineral density (vBMD) by quantitative computed tomography (QCT) and muscle mass at mid-femur by computed tomography (CT) at 3 years in the 3 groups of: 1) men; 2) premenopausal women; 3) postmenopausal women after SG versus their respective non-surgical peers who did not undergo SG in the 3-year period following recruitment. Secondary aims: to compare the changes in vBMD by QCT at skeletal sites other than the spine and in areal bone mineral density (aBMD) by dual-energy X-ray absorptiometry (DXA), whole-body muscle mass by DXA, muscle quality by CT at mid-femur and muscle strength as well as in selected physical performance and capacity tests shown to predict falls and fractures between 0-1 and 1-3 years after SG in the same 3 groups after SG vs. in the respective non-surgical groups.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleeve gastrectomy - Men | n = 39 men with obesity undergoing sleeve gastrectomy |
| |
| Sleeve gastrectomy - Premenopausal women | n = 39 premenopausal women with obesity undergoing sleeve gastrectomy |
| |
| Sleeve gastrectomy - Postmenopausal women | n = 39 postmenopausal women with obesity undergoing sleeve gastrectomy |
| |
| Obese non-surgical group | n = 39 (13 men, 13 premenopausal and 13 postmenopausal women) obese non-surgical individuals |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bariatric surgery | Procedure | Sleeve gastrectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in vBMD at the spine (L2-L3) and proximal femur | assessed by QCT | before, 1 year after and 3 years after bariatric surgery |
| Change in muscle mass at mid-femur | determined by measuring cross-sectional area at mid-femur (CT) | before, 1 year after and 3 years after bariatric surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in vBMD at skeletal sites other than the spine | assessed by QCT | before, 1 year after and 3 years after bariatric surgery |
| Change in aBMD at skeletal sites | assessed by DXA |
| Measure | Description | Time Frame |
|---|---|---|
| The clinical impact of SG on self-reported falls | by self-reported questionnaire (yes/No) | before, 1 year after and 3 years after bariatric surgery |
| The clinical impact of SG on self-reported incidence of vertebral and non-vertebral fractures |
Inclusion Criteria:
Exclusion Criteria:
Gender role has been shown to influence lifestyle behaviours such as physical activity and nutrition. It is however unknown whether gender role influences adherence to the American Society for Metabolic and Bariatric Surgery physical activity and dietary intake/supplement recommendations that are important for bone/muscle health after bariatric surgery. A short questionnaire, the validated 12-item Bem Sex Role Inventory, will be administered to the participants to categorize them into 4 gender role categories. In an exploratory descriptive analysis, the investigators will calculate the proportion of participants in each gender role category meeting the dietary/supplement intake and physical activity recommendations and document the type and amount of physical activity they perform.
Not provided
This is a multicentre, prospective and observational study comprising a SG bariatric group undergoing SG (n=117) comprising an equal number of men, premenopausal and postmenopausal women (n=39/group) meeting the inclusion/exclusion criteria, and assessed before, and at one and 3 years after SG. An obese non-surgical group (n=39; 13 men, premenopausal and postmenopausal women) meeting the criteria for SG but who will not undergo surgery during the 3-year period following recruitment will be assessed using the same tests and at the same timepoints.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandrine Hegg-Deloye, PhD | Contact | 4185254444 | 48729 | sandrine.hegg-deloye@crchudequebec.ulaval.ca |
| Name | Affiliation | Role |
|---|---|---|
| Claudia Gagnon, Dr | CHU de Québec - Université Laval | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de recherche de l'IUCPQ | Recruiting | Québec | G1V 4G5 | Canada |
Not provided
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood (serum and plasma)
| before, 1 year after and 3 years after bariatric surgery |
| Change in whole body muscle mass | assessed by DXA | before, 1 year after and 3 years after bariatric surgery |
| Change in muscle quality at mid-femur | muscle fat infiltration, using CT attenuation in Hounsfield unit (HU) | before, 1 year after and 3 years after bariatric surgery |
| Change in muscle strength | assessed by CT | before, 1 year after and 3 years after bariatric surgery |
| Change in upper extremity muscle strength | by hand grip strength | before, 1 year after and 3 years after bariatric surgery |
| Change in lower extremity muscle strength | knee extensor strength | before, 1 year after and 3 years after bariatric surgery |
| Change in muscle mass (muscle cross-sectional area) and function | by timed up and go test | before, 1 year after and 3 years after bariatric surgery |
| Change in muscle mass (muscle cross-sectional area) and function | by 6-minute walk test | before, 1 year after and 3 years after bariatric surgery |
by questionnaire (yes/No and number of fractures, how)
| before, 1 year after and 3 years after bariatric surgery |
| The proportion of participants meeting the recommendations for physical activity | by international physical activity questionnaire short version (score in MET-min/week), (Min 495 MET-minute/week, Max 1200 MET-minute/week) | before, 1 year after and 3 years after bariatric surgery |
| The proportion of participants meeting the recommendations for dietary protein intake | Dietary journal, Calculating macronutrient and micronutrient intake per day 3 web-based 24-h recalls | before, 1 year after and 3 years after bariatric surgery |
| The proportion of participants meeting the recommendations for calcium and vitamin D intake from diet and supplements | serum D vitamin (25ODH) in blood sample | before, 1 year after and 3 years after bariatric surgery |
| The proportion of participants meeting the recommendations for calcium and vitamin D intake from diet and supplements | Parathyroid hormone (PTH) in blood sample | before, 1 year after and 3 years after bariatric surgery |
| Changes in C-Telopeptide, amino-terminal propeptide of type 1 procollagen (P1NP), osteocalcin | assessed by blood sample. unit: micro g/l | before, 1 year after and 3 years after bariatric surgery |
| Changes in calcium, | assessed by blood sample. unit: mmol/l | before, 1 year after and 3 years after bariatric surgery |
| Changes in albumin, | assessed by blood sample. unit:g/l | before, 1 year after and 3 years after bariatric surgery |
| Changes in creatinin | assessed by blood sample. unit: micromol/l | before, 1 year after and 3 years after bariatric surgery |
| Changes in folliculo-stimulant (FSH) | assessed by blood sample. unit: UI/l FSH will help categorize hysterectomized women or those with non-menopausal amenorrhea. Premenopause will be defined as menses in the last year. | FSH will be measured at the time of surgery, when women had withdrawn their hormones for 3 months preceding surgery. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |