Calcium Metabolism DisordersNCT02778490
Effects of Sleeve Gastrectomy on Calcium Metabolism and the Skeleton
An observational study of Calcium Metabolism Disorders and Morbid Obesity, run by San Francisco Veterans Affairs Medical Center at 1 site in United States.
Trial summary
In this pre-post observational study, the investigators will enroll and follow a cohort of about 50 adults undergoing sleeve gastrectomy surgery for weight loss. Pre-operatively and at 6 and 12 months post-operatively, the investigators will use state-of-the-art metabolic and imaging techniques to evaluate calcium… Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Calcium Metabolism Disorders, Morbid Obesity
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2016to 28 Nov 2021
- Phase
- Observational
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese men and women undergoing sleeve gastrectomy surgery
Who may be able to join
- Women and men 25 to 70 years old scheduled to undergo sleeve gastrectomy
- Please note that the investigators are unable to provide sleeve gastrectomy; rather, potential participants must already be planning the procedure with their surgeons.
Who cannot join
- Perimenopausal women, defined as last menses >3 months but < 5 years ago
- Known intestinal malabsorption (e.g., celiac disease, short gut syndrome, prior intestinal surgery)
- Prior bariatric surgery
- Use of medications known to impact bone and mineral metabolism, including use of a bisphosphonate or teriparatide in the last year or for >12 months ever; current calcitonin; prednisone >5 mg daily or the equivalent glucocorticoid for >10 days in the last 3 months; a current thiazolidinedione (TZD); an aromatase inhibitor; androgen deprivation therapy; an antiepileptic agent known to alter hepatic vitamin D clearance; or thyroid hormone replacement with current thyroid stimulating hormone < 0.1 milli-international units per liter
- Disease known to affect bone (e.g., primary hyperparathyroidism, Pagets disease, clinically significant liver disease)
- Illicit drug use or alcohol use >3 drinks/day
- Serum calcium >10.2 mg/dL or calculated creatinine clearance < 30 mL/min
- Weight >350 pounds (the maximum weight limit of the QCT scanner) at the time of the pre-operative QCT scan
Trial locations and contacts
1 site in 1 country.
About this study
In this pre-post observational study, the investigators will enroll and follow a cohort of about 50 adults undergoing sleeve gastrectomy surgery for weight loss. Pre-operatively and at 6 and 12 months post-operatively, the investigators will use state-of-the-art metabolic and imaging techniques to evaluate calcium metabolism and skeletal health. Specific outcomes include intestinal calcium absorption capacity, bone mineral density (BMD) assessed by dual-energy X-ray absorptiometry (DXA) and quantitative computed tomography (QCT), and bone structure assessed by QCT and high-resolution peripheral QCT (HR-pQCT).
Read the detailed description
Obesity is a chronic disease of staggering proportions. Because weight loss through diet and exercise is difficult to attain and maintain, there is escalating interest in surgical weight loss procedures, including Roux-en-Y gastric bypass. Gastric bypass results in marked and durable weight loss and improvement in comorbidities in the general population and in our veteran patients. However, growing evidence indicates that gastric bypass can have negative effects on the skeleton, increasing bone turnover and decreasing bone mineral density (BMD). This is of critical concern given the tremendous impact of osteoporosis and fracture in both men and women. Vitamin D deficiency due to obesity and post-surgical malabsorption may partially explain the decline in bone mass observed after gastric bypass. Other factors are likely involved as well, such as non-vitamin D-mediated calcium malabsorption, signals related to decreased skeletal loading, and changes in fat-secreted hormones or estrogen (due to changes in fat mass and body composition).
We will characterize the effects of gastric bypass on calcium metabolism and the skeleton in a cohort of 80 men and women whose serum 25-hydroxyvitamin D levels are supplemented and maintained at ≥30 ng/mL. First, we will test the hypothesis that intestinal calcium absorption is impaired following gastric bypass, even in the setting of vitamin D sufficiency. We will do this by measuring fractional calcium absorption pre-operatively and 6 months post-operatively using dual stable isotopic tracers (Aim 1). Then, we will test the hypothesis that gastric bypass results in decreased BMD and in structural changes associated with impaired skeletal strength. We will do this by performing dual-energy X-ray absorptiometry (DXA), quantitative computed tomography (QCT), and high-resolution peripheral QCT (HR-pQCT) pre-operatively and 6 and 12 months post-operatively (Aim 2). QCT and HR-pQCT are advanced imaging techniques that have distinct advantages over standard methods but have not yet been applied to this population. Finally, we will assess body composition changes by anthropometry, DXA, and QCT, and changes in fat-secreted hormones, and we will evaluate the relationship between changes in skeletal parameters and changes in body composition and hormones (Aim 3). This research is expected to impact the clinical care of gastric bypass patients by helping to shape recommendations about post-operative nutrition, BMD screening, and potential therapy.
As an ancillary study aim (Aim 4), we will assess vertebral bone marrow fat pre- and post-operatively in a subgroup of participants, and we will evaluate the relationships between change in vertebral bone marrow fat, changes in body composition and fat-secreted hormones, and changes in skeletal parameters. The participants in this subgroup will have the option of undergoing additional knee tissue composition evaluation, allowing us to evaluate the relationship between weight loss and change in knee health. In order to develop and refine the magnetic resonance (MR) sequences we will use for Aim 4, we will scan a small group of healthy controls at baseline and after 6 months.
- Conditions
- Calcium Metabolism Disorders, Morbid Obesity
- Keywords
- sleeve gastrectomy, bariatric surgery
- Medical subject headings
- Calcium Metabolism Disorders, Obesity, Morbid
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intestinal fractional calcium absorption
The investigators will determine whether there is a change in intestinal calcium absorption, assessed using the dual stable isotopes Ca-43 and Ca-44 in the setting of robust vitamin D status, following sleeve gastrectomy.
Measured: 6 months
Secondary outcomes (3)
Percentage change in spinal volumetric bone mineral density
The investigators will define the effects of sleeve gastrectomy on spinal volumetric bone mineral density, assessed by quantitative computed tomography (QCT).
Measured: 12 months
Percentage change in volumetric bone mineral density at the distal tibia
The investigators will define the effects of sleeve gastrectomy on total volumetric bone mineral density at the distal tibia, assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT).
Measured: 12 months
Percentage change in cortical porosity at the distal tibia
The investigators will define the effects of sleeve gastrectomy on cortical porosity at the distal tibia, assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study start15 Jun 2016
- Primary completion28 Nov 2021
- Study completion28 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcium Metabolism DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Francisco Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- University of California, San Francisco, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Anne Schafer, San Francisco Veterans Affairs Medical Center
- Investigators
- Anne Schafer, MD, Principal investigator, San Francisco VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778490
- Sponsor's protocol ID
- R01DK107629
- Other IDs
- R01DK107629
- Status last verified
- Oct 2022
- First submitted
- 15 May 2016
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sleeve Gastrectomy on Calcium Metabolism and the Skeleton
- ClinicalTrials.gov ID
- NCT02778490
- Acronym / sponsor ID
- R01DK107629
- Conditions
- Calcium Metabolism Disorders, Morbid Obesity
- Keywords
- sleeve gastrectomy, bariatric surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- San Francisco Veterans Affairs Medical CenterUS federal agency
- Collaborators
- University of California, San Francisco, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 28 Nov 2021 (actual)
- Study completion
- 28 Nov 2021 (actual)
- First posted
- 20 May 2016 (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.
In this pre-post observational study, the investigators will enroll and follow a cohort of about 50 adults undergoing sleeve gastrectomy surgery for weight loss. Pre-operatively and at 6 and 12 months post-operatively, the investigators will use state-of-the-art metabolic and imaging techniques to evaluate calcium metabolism and skeletal health. Specific outcomes include intestinal calcium absorption capacity, bone mineral density (BMD) assessed by dual-energy X-ray absorptiometry (DXA) and quantitative computed tomography (QCT), and bone structure assessed by QCT and high-resolution peripheral QCT (HR-pQCT).
Detailed description
Obesity is a chronic disease of staggering proportions. Because weight loss through diet and exercise is difficult to attain and maintain, there is escalating interest in surgical weight loss procedures, including Roux-en-Y gastric bypass. Gastric bypass results in marked and durable weight loss and improvement in comorbidities in the general population and in our veteran patients. However, growing evidence indicates that gastric bypass can have negative effects on the skeleton, increasing bone turnover and decreasing bone mineral density (BMD). This is of critical concern given the tremendous impact of osteoporosis and fracture in both men and women. Vitamin D deficiency due to obesity and post-surgical malabsorption may partially explain the decline in bone mass observed after gastric bypass. Other factors are likely involved as well, such as non-vitamin D-mediated calcium malabsorption, signals related to decreased skeletal loading, and changes in fat-secreted hormones or estrogen (due to changes in fat mass and body composition).
We will characterize the effects of gastric bypass on calcium metabolism and the skeleton in a cohort of 80 men and women whose serum 25-hydroxyvitamin D levels are supplemented and maintained at ≥30 ng/mL. First, we will test the hypothesis that intestinal calcium absorption is impaired following gastric bypass, even in the setting of vitamin D sufficiency. We will do this by measuring fractional calcium absorption pre-operatively and 6 months post-operatively using dual stable isotopic tracers (Aim 1). Then, we will test the hypothesis that gastric bypass results in decreased BMD and in structural changes associated with impaired skeletal strength. We will do this by performing dual-energy X-ray absorptiometry (DXA), quantitative computed tomography (QCT), and high-resolution peripheral QCT (HR-pQCT) pre-operatively and 6 and 12 months post-operatively (Aim 2). QCT and HR-pQCT are advanced imaging techniques that have distinct advantages over standard methods but have not yet been applied to this population. Finally, we will assess body composition changes by anthropometry, DXA, and QCT, and changes in fat-secreted hormones, and we will evaluate the relationship between changes in skeletal parameters and changes in body composition and hormones (Aim 3). This research is expected to impact the clinical care of gastric bypass patients by helping to shape recommendations about post-operative nutrition, BMD screening, and potential therapy.
As an ancillary study aim (Aim 4), we will assess vertebral bone marrow fat pre- and post-operatively in a subgroup of participants, and we will evaluate the relationships between change in vertebral bone marrow fat, changes in body composition and fat-secreted hormones, and changes in skeletal parameters. The participants in this subgroup will have the option of undergoing additional knee tissue composition evaluation, allowing us to evaluate the relationship between weight loss and change in knee health. In order to develop and refine the magnetic resonance (MR) sequences we will use for Aim 4, we will scan a small group of healthy controls at baseline and after 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese men and women undergoing sleeve gastrectomy surgery
Key inclusion criteria (2 listed)
- Women and men 25 to 70 years old scheduled to undergo sleeve gastrectomy
- Please note that the investigators are unable to provide sleeve gastrectomy; rather, potential participants must already be planning the procedure with their surgeons.
Key exclusion criteria (8 listed)
- Perimenopausal women, defined as last menses >3 months but < 5 years ago
- Known intestinal malabsorption (e.g., celiac disease, short gut syndrome, prior intestinal surgery)
- Prior bariatric surgery
- Use of medications known to impact bone and mineral metabolism, including use of a bisphosphonate or teriparatide in the last year or for >12 months ever; current calcitonin; prednisone >5 mg daily or the equivalent glucocorticoid for >10 days in the last 3 months; a current thiazolidinedione (TZD); an aromatase inhibitor; androgen deprivation therapy; an antiepileptic agent known to alter hepatic vitamin D clearance; or thyroid hormone replacement with current thyroid stimulating hormone < 0.1 milli-international units per liter
- Disease known to affect bone (e.g., primary hyperparathyroidism, Pagets disease, clinically significant liver disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in intestinal fractional calcium absorption
Time frame: 6 months
The investigators will determine whether there is a change in intestinal calcium absorption, assessed using the dual stable isotopes Ca-43 and Ca-44 in the setting of robust vitamin D status, following sleeve gastrectomy.
3 secondary outcomes
Percentage change in spinal volumetric bone mineral density
Time frame: 12 months
Percentage change in volumetric bone mineral density at the distal tibia
Time frame: 12 months
Percentage change in cortical porosity at the distal tibia
Time frame: 12 months
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 28 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Anne Schafer, MD principal investigator
San Francisco VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Calcium Metabolism Disorders and Morbid Obesity, run by San Francisco Veterans Affairs Medical Center at 1 site in United States.
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 8 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 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Change in intestinal fractional calcium absorption (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2022.