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| ID | Type | Description | Link |
|---|---|---|---|
| 1IK2CX000549-01 | U.S. NIH Grant/Contract | View source |
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Obesity is a chronic illness of staggering proportions. Because weight loss through diet and exercise is difficult to attain and maintain, there has been escalating interest in bariatric surgery, including Roux-en-Y gastric bypass. Gastric bypass surgery results in long-term weight loss, dramatic improvement in comorbidities such as diabetes, and decreased mortality. Emerging evidence suggests, however, that gastric bypass may have negative effects on bone health. Because of the serious consequences of osteoporosis and fracture, this is of great concern. This study of the effects of gastric bypass on calcium metabolism and the skeleton may positively impact the clinical care of gastric bypass patients by their surgeons, primary care providers, and endocrinologists. Further, the knowledge gained may inform future investigation into the relationships between obesity, weight loss, and bone biology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastric Bypass Surgery Patients | Obese men and women undergoing gastric bypass surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Intestinal Calcium Absorption | Change in fractional calcium absorption, determined by dual stable isotope method. Fractional calcium absorption is the fraction of ingested calcium that is absorbed, which is expressed here as the percentage of ingested calcium that is absorbed. The 6-month change is the mean difference in percentage absorption between time points. For example, if fractional calcium absorption were to decrease from 30% preoperatively to 25% at the 6-month postoperative time point, the change in fractional calcium absorption would be -5%. | 6 months (between baseline and 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Areal Bone Mineral Density (BMD) at the Femoral Neck | Areal BMD at the femoral neck by dual-energy X-ray absorptiometry (DXA). The 12-month change is the percentage change between the 12 month and baseline time points. | 12 months post-operatively (between baseline and 12 months) |
| Trabecular Number at the Tibia |
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Inclusion Criteria:
Scheduled to undergo gastric bypass surgery. Please note that to be eligible, one must already be working with a bariatric surgeon and with plans in place to undergo gastric bypass. This study is unable to arrange or pay for gastric bypass surgery.
Exclusion Criteria:
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Men and women 25 to 70 years old scheduled to undergo gastric bypass surgery
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| Name | Affiliation | Role |
|---|---|---|
| Anne L Schafer, MD | San Francisco VA Medical Center, San Francisco, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco VA Medical Center, San Francisco, CA | San Francisco | California | 94121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25640580 | Result | Schafer AL, Weaver CM, Black DM, Wheeler AL, Chang H, Szefc GV, Stewart L, Rogers SJ, Carter JT, Posselt AM, Shoback DM, Sellmeyer DE. Intestinal Calcium Absorption Decreases Dramatically After Gastric Bypass Surgery Despite Optimization of Vitamin D Status. J Bone Miner Res. 2015 Aug;30(8):1377-85. doi: 10.1002/jbmr.2467. Epub 2015 May 21. | |
| 25603463 | Result | Schafer AL, Li X, Schwartz AV, Tufts LS, Wheeler AL, Grunfeld C, Stewart L, Rogers SJ, Carter JT, Posselt AM, Black DM, Shoback DM. Changes in vertebral bone marrow fat and bone mass after gastric bypass surgery: A pilot study. Bone. 2015 May;74:140-5. doi: 10.1016/j.bone.2015.01.010. Epub 2015 Jan 17. |
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Women and men 25-70 years of age were recruited from two academic bariatric surgery centers (the University of California, San Francisco and the San Francisco Veterans Affairs Medical Center), where surgeons used the same standardized surgical approach to Roux-en-Y gastric bypass.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gastric Bypass Surgery Patients | Obese men and women undergoing gastric bypass surgery |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gastric Bypass Surgery Patients | Obese men and women undergoing gastric bypass surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Intestinal Calcium Absorption | Change in fractional calcium absorption, determined by dual stable isotope method. Fractional calcium absorption is the fraction of ingested calcium that is absorbed, which is expressed here as the percentage of ingested calcium that is absorbed. The 6-month change is the mean difference in percentage absorption between time points. For example, if fractional calcium absorption were to decrease from 30% preoperatively to 25% at the 6-month postoperative time point, the change in fractional calcium absorption would be -5%. | Participants from the cohort who underwent assessment of fractional calcium absorption preoperatively and 6 months postoperatively | Posted | Mean | Standard Deviation | % of ingested calcium that is absorbed | 6 months (between baseline and 6 months) |
|
12 months
Participants were asked about interim adverse events at baseline, 6-month, and 12-month study visits. Adverse events volunteered by participants between study visits were also recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gastric Bypass Surgery Patients | Obese men and women undergoing gastric bypass surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne Schafer | San Francisco Veterans Affairs Medical Center | (415) 221-4810 | 24895 | anne.schafer@va.gov |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D002128 | Calcium Metabolism Disorders |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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serum, urine
Trabecular number at the tibia by high-resolution peripheral quantitative computed tomography (HR-pQCT). The 12-month change is the percentage change between the 12 month and baseline time points. HR-pQCT images were analyzed using the manufacturer's standard clinical evaluation protocol, with trabecular structure extracted using a threshold-based binarization process. |
| 12 months post-operatively (between baseline and 12 months) |
| 39351881 | Derived | Chakhtoura MT, Nakhoul NF, Akl EA, Safadi BY, Mantzoros CS, Metzendorf MI, El-Hajj Fuleihan G. Oral vitamin D supplementation for adults with obesity undergoing bariatric surgery. Cochrane Database Syst Rev. 2024 Oct 1;10(10):CD011800. doi: 10.1002/14651858.CD011800.pub2. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Menopausal status | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body mass index | Mean | Standard Deviation | kg/m2 |
|
| Percentage body fat | Mean | Standard Deviation | percentage of body fat |
|
| Diabetes status | Number | participants |
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| Femoral neck areal bone mineral density (DXA) | Mean | Standard Deviation | g/cm2 |
|
| Spine volumetric bone mineral density (QCT) | Mean | Standard Deviation | g/cm3 |
|
|
|
| Secondary | Areal Bone Mineral Density (BMD) at the Femoral Neck | Areal BMD at the femoral neck by dual-energy X-ray absorptiometry (DXA). The 12-month change is the percentage change between the 12 month and baseline time points. | participants who underwent DXA at pre-op and 12-month post-op time points | Posted | Mean | Standard Deviation | percent of baseline value | 12 months post-operatively (between baseline and 12 months) |
|
|
|
| Secondary | Trabecular Number at the Tibia | Trabecular number at the tibia by high-resolution peripheral quantitative computed tomography (HR-pQCT). The 12-month change is the percentage change between the 12 month and baseline time points. HR-pQCT images were analyzed using the manufacturer's standard clinical evaluation protocol, with trabecular structure extracted using a threshold-based binarization process. | participants who underwent HR-pQCT at pre-op and 12-month post-op time points | Posted | Mean | Standard Deviation | percent of baseline value | 12 months post-operatively (between baseline and 12 months) |
|
|
|
| 1 |
| 55 |
| 3 |
| 55 |
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008659 | Metabolic Diseases |
| D001836 | Body Weight Changes |