Study Results
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Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2007-04-30
2009-12-31
Brief Summary
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Detailed Description
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Bone remodeling is a complex process involving bone resorption and formation-a process dependent upon local and systemic influences. Obesity is one of these influences that is poorly understood. Obesity is associated with a reduced risk of osteoporosis. Obesity may be protective due to increased weight bearing, increased production of estrogen by adipose tissue, or increased bone formation due to higher levels of insulin.
It is known that weight loss in healthy individuals is associated with bone loss. Several small studies have reported bone loss in patients undergoing vertical band gastroplasty or jejunoileal bypass weight loss surgeries. Other reported metabolic disease disarrangements following weight loss surgery are decreased serum calcium, decreased serum 25-hydroxy vitamin D, and hyperparathyroidism.
In the bariatric literature, weight loss has been associated with an increased risk of bone mineral loss and fracture. Osteoporosis has been described in patients who lost weight after jejunoileal bypass surgery. Premenopausal women appeared to be spared from bone mineral loss, thus indicating a protective effect from the premenopausal state. Bone mineral loss is seen both in premenopausal women and in men after weight loss surgery.
Roux-en Y gastric bypass has been shown to be more effective at weight loss than has the adjustable silicone gastric band. It has also been linked with increased loss of bone mineral density. Another study found an increase in bone turnover as well as a decrease in total bone mass and trochanteric bone density in laparoscopic Roux-en Y gastric bypass patients.
Previous research at our institution has shown a statistically significant increase in the prevalence of hyperparathyroidism in post-gastric bypass patients. However, our previous research did not examine the impact that these hormonal changes impart upon bone density. We have found a statistically significant incidence of vitamin D deficiency in our patients following this surgery. We intend to expand upon our own research as well as that of others by exploring the associations between the development of hyperparathyroidism, bone metabolic derangements, weight loss, and bone density.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Bone Density Study Group
Morbidly obese, (BMI \>40 kg/m2, or 35 kg/m2 with comorbidities) female patients who have given consent to undergo additional testing including bone densitometry, and lab testing preoperatively and at 6 and 12 months after undergoing elective laparoscopic roux-en-Y gastric bypass.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients unable to fulfill the study protocol requirements
30 Years
65 Years
FEMALE
No
Sponsors
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Gundersen Lutheran Health System
OTHER
Gundersen Lutheran Medical Foundation
OTHER
Responsible Party
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Kara Kallies
Academic Researcher
Principal Investigators
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Shanu N Kothari, M.D.
Role: PRINCIPAL_INVESTIGATOR
Gundersen Lutheran Health System
Kevin P Riess, M.D.
Role: PRINCIPAL_INVESTIGATOR
Gundersen Lutheran Medical Foundation; Current Practice: SMDC Health System-Duluth Clinic
Locations
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Gundersen Lutheran Health System
La Crosse, Wisconsin, United States
Countries
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References
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Must A, Spadano J, Coakley EH, Field AE, Colditz G, Dietz WH. The disease burden associated with overweight and obesity. JAMA. 1999 Oct 27;282(16):1523-9. doi: 10.1001/jama.282.16.1523.
Morberg CM, Tetens I, Black E, Toubro S, Soerensen TI, Pedersen O, Astrup A. Leptin and bone mineral density: a cross-sectional study in obese and nonobese men. J Clin Endocrinol Metab. 2003 Dec;88(12):5795-800. doi: 10.1210/jc.2003-030496.
Cundy T, Evans MC, Kay RG, Dowman M, Wattie D, Reid IR. Effects of vertical-banded gastroplasty on bone and mineral metabolism in obese patients. Br J Surg. 1996 Oct;83(10):1468-72. doi: 10.1002/bjs.1800831046.
von Mach MA, Stoeckli R, Bilz S, Kraenzlin M, Langer I, Keller U. Changes in bone mineral content after surgical treatment of morbid obesity. Metabolism. 2004 Jul;53(7):918-21. doi: 10.1016/j.metabol.2004.01.015.
Meyer HE, Tverdal A, Selmer R. Weight variability, weight change and the incidence of hip fracture: a prospective study of 39,000 middle-aged Norwegians. Osteoporos Int. 1998;8(4):373-8. doi: 10.1007/s001980050077.
Bano G, Rodin DA, Pazianas M, Nussey SS. Reduced bone mineral density after surgical treatment for obesity. Int J Obes Relat Metab Disord. 1999 Apr;23(4):361-5. doi: 10.1038/sj.ijo.0800827.
Coates PS, Fernstrom JD, Fernstrom MH, Schauer PR, Greenspan SL. Gastric bypass surgery for morbid obesity leads to an increase in bone turnover and a decrease in bone mass. J Clin Endocrinol Metab. 2004 Mar;89(3):1061-5. doi: 10.1210/jc.2003-031756.
Goode LR, Brolin RE, Chowdhury HA, Shapses SA. Bone and gastric bypass surgery: effects of dietary calcium and vitamin D. Obes Res. 2004 Jan;12(1):40-7. doi: 10.1038/oby.2004.7.
Carlin AM, Rao DS, Yager KM, Parikh NJ, Kapke A. Treatment of vitamin D depletion after Roux-en-Y gastric bypass: a randomized prospective clinical trial. Surg Obes Relat Dis. 2009 Jul-Aug;5(4):444-9. doi: 10.1016/j.soard.2008.08.004. Epub 2008 Aug 14.
Other Identifiers
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2-07-02-009
Identifier Type: -
Identifier Source: org_study_id
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