Obesity Clinical Trial
Official title:
BaSEIB Clinical Trial - Bariatric Surgery and Exercise Intervention Bone Trial
Despite being effective in weight reduction in severely obese patients, bariatric surgery
(BS) negatively influences bone metabolism and increases the risk of falls thereby
potentially increasing the risk of fracture. The mechanisms of BS induced bone loss are
unknown but may be related to calcium and vitamin D malabsorption, changes in the energy
regulation metabolism and gastrointestinal hormonal physiology. Since the etiology of BS
induced bone loss is largely unknown, treatment relies mostly on calcium and vitamin D
supplementation, which provide little benefit.
Exercise is an effective strategy to prevent bone mass losses in several health conditions.
However, no study so far has examined the effects of an exercise-training program in the
prevention of BS induced bone loss. The investigators main goal is to investigate the effects
on bone metabolism and fracture risk of an exercise-training program specifically tailored to
improve bone health and balance of patients that underwent BS. The investigators will perform
a randomized controlled trial on obese patients (n=80; BMI>40 Kg.m-2) elected to BS. Patients
will be randomly assigned into 2 groups i) a group receiving standard follow-up and medical
care, or ii) a group that will undergo a 11 months' Exercise Training program designed to
improve bone health and reduce fall risk plus the standard follow-up and medical care. All
patients will be assessed i) before the surgery, ii) one month, iii) 6 months, and iv) 12
months after the surgery. Assessments include: biochemical markers of bone turnover (BTM),
BMD, bone tissue biomechanical properties, hormones involved in the regulation of energy,
gastrointestinal and bone metabolism, body composition, BMI, nutritional intake, balance,
muscle strength, cardiorespiratory fitness and daily physical activity. These evaluations
will allow the investigators to understand the effects of an exercise-training program on
bone metabolism of BS patients, contributing also to further elucidate the mechanisms
underlying BS induced bone loss and fracture risk increase. The investigators will use
established methods in the literature as well as novel procedures, which will enable them to
overcome some of the limitations of previous studies. At the end of the study the
investigators expect to have collected consistent data about whether an exercise-training
program is or is not able to effectively prevent BS induced bone losses and fracture risk
increases.
The investigators main goal is to determine if an Exercise-Training Intervention program
(ETI) tailored to improve bone health, strength and balance, is effective in preventing
Roux-en-Y gastric bypass (RYGB) induced fracture risk. To achieve this the investigators will
perform a randomized clinical trial (RCT) on volunteer obese patients (BMI>35 Kg.m-2)
undergoing RYGB that will be followed for 13-months (Figure 1). The patients will be
recruited, operated and will receive follow-up medical care in the Department of General
Surgery from the Centro Hospitalar de São João E.P.E (DSHSJ). After being elected for RYGB
and if inclusion and exclusion criteria are met, patients who decide to join the study will
be randomly assigned to either i) participate in a 11 months duration ETI tailored to improve
bone health and reduce fall risk in addition to the standard follow-up medical care (MFU)
(ETI+MFU group), or ii) will receive only MFU (control group). Recruiting patients from only
one institution will increase the likelihood of all patients receiving the same surgical and
MFU care, reducing the bias related to the use of different clinical protocols. The option to
include only RYGB is also to reduce the bias associated with the surgical technique.
Participants allocated to the ETI+MFU group will undergo an exercise-training program of 11
months duration, 3 sessions/week, and 60 minutes/session, starting one month after the
surgery. Each exercise session will be supervised and will include 5 major components: i)
warm-up, ii) multidirectional jumps, iii) balance, iv) strength and, v) cool down. This
structure is planned to meet two main objectives: i) enhance bone formation and, ii) reduce
fall risk by improving muscle strength, cardiorespiratory fitness and balance. The ETI will
last almost 1 year because the effects of BS on bone metabolism have been shown to be
greatest during the first postoperative year (1). As the investigators main objective is to
understand, in a broad perspective, the possible therapeutic benefits that an ETI has on the
BS patient bone health and fracture risk, the plan is to investigate several variables in
this study (bone turnover markers, bone mineral content (BMC) and density (BMD), body
composition, body mass index (BMI), nutritional intake, static balance, dynamic balance,
muscle strength of the lower limbs and trunk, daily physical activity, cardiorespiratory
fitness, bone derived hormones, hormones involved in phosphate and calcium metabolism,
adipokines, gastrointestinal and energy-metabolism hormones and gonadal hormones). These will
enable the investigators to comprehensively understand the metabolic changes following BS
that might affect bone health, and how can exercise influence those changes potentially
preventing fracture risk increases.
Each patient will be assessed 4 times during the study (Figure 1). Each assay will match the
monitoring protocols already scheduled by the DSHSJ for all patients undergoing BS. The 1st
evaluation will occur prior to BS, to gather pre-surgical state. The 2nd, 3rd and 4th
evaluations will occur in the 1st (before the beginning of the exercise-training program for
the patients allocated to the exercise intervention group), 6th and 12th months after
bariatric surgery, respectively. The variables analyzed at each time point fit into four
major categories: i) bone quality surrogates (BTM, BMD, bone biomechanical properties); ii)
anthropometry (weight, height, body composition, nutritional intake; iii) fall risk (static
and dynamic balance, muscle strength, cardiorespiratory fitness, daily physical activity),
iv) hormones involved in calcium, bone and gastro-intestinal metabolism. Biochemical analysis
will be performed in blood samples collected during follow up hospital visits. Biochemical
markers of bone turnover (BTM) reflect the degree of bone remodeling and the balance between
formation and resorption and are therefore surrogates of fracture risk. As BS profoundly
affects body composition, gastrointestinal and energy-regulation physiology, and because
adipose tissue and gut-associated hormones also influence bone metabolism, the investigators
will determine how these hormones are affected by RYGB and exercise. By monitoring these
variables the investigators will gain insight on the etiological mechanisms associated with
BS induced bone loss and the therapeutic effects of exercise. BS also leads to a reduction in
calcium and vitamin D absorption, which may result in increased bone resorption. The
investigators will therefore also monitor Vitamin D, Parathyroid Hormone (PTH), calcium and
phosphorous concentrations to determine how they are influenced by the ETI. Despite
mechanical unloading due to the weight loss may contribute to bone loss following BS, there
is no data supporting this mechanism. To investigate this relation, the investigators will
also monitor serum sclerostin, a protein released by osteocytes in response to mechanical
unloading that negatively regulates bone formation. To determine the effects of BS and
exercise on skeletal muscle and adipose tissue mass, the investigators will measure body
composition and BMI in all patients. As one of the investigators main goal is to investigate
the effects of the ETI on fall risk, they also plan to determine the cardiorespiratory
fitness and muscle strength in these patients since these variables have been previously
shown to influence fall risk. Daily physical activity and nutritional intake will also be
determined by accelerometer and food diary, respectively, in order to control for confounding
variables. Despite the several caveats associated with the determination of BMD by DXA, the
investigators plan to analyze this variable, as it will provide data that will enable them to
compare their results with the results from previous studies. Nevertheless, the investigators
plan to complement this information with the direct assessment of bone biomechanical
properties, which until recently was only available in in vitro studies due to the invasive
nature of the procedure. Bone micro-indentation is a newer technique that allows measuring
bone tissue mechanical properties in the clinical setting, which reflects with higher
accuracy the bone resistance to fracture (6). One of the main outcomes in this research is to
investigate the effects of BS on fall risk, as there is almost no data on this issue. This
will be accomplished by direct determination of static and dynamic balance by means of using
a forces platform. By analyzing this broad set of parameters the investigators plan to
contribute with a more thorough understanding of the effects of BS on bone metabolism and,
most importantly, how can an exercise training program, specifically tailored to improve bone
health and balance, can reduce the risk of bone fractures in these patients. Only by
analyzing this broad number of parameters will the investigators be able to control the
several confounding variables and gain deeper insight into the effects of BS and exercise on
the bone metabolism of these patients, thereby contributing with a potently useful strategy
for the management of skeletal health in BS patients.
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