Obesity Clinical Trial
— BaSEIBOfficial title:
BaSEIB Clinical Trial - Bariatric Surgery and Exercise Intervention Bone Trial
Verified date | October 2017 |
Source | Universidade do Porto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 86 |
Est. completion date | March 2019 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - meet the referral criteria for bariatric surgery; - BMI >40 kg.m-2 or >35 kg.m-2 with obesity-related comorbidities; - Motivation to participate in the study, regardless to the allocation group Exclusion Criteria: - use of drugs that interfere with bone metabolism (i.e. bisphosphonates, teriparatide, calcitonin, hormone replacement therapy, chronic use of corticosteroids, thiazide diuretics); - Unable to perform exercise of moderate intensity; - Health condition that could be aggravated by exercise (i.e. uncontrolled arterial hypertension, severe kidney disease, class III New York Heart Association heart failure); - Peri-menopausal status with last menstruation <1 year; - Known metabolic bone disease (i.e. Osteogenesis Imperfecta, Paget bone disease); - Concurrent participation in a structured exercise program (>30 min in duration >1 day/week); - Pregnancy or breast-feeding |
Country | Name | City | State |
---|---|---|---|
Portugal | Faculdade de Desporto | Porto |
Lead Sponsor | Collaborator |
---|---|
Universidade do Porto | Centro Hospitalar De São João, E.P.E., Fundação para a Ciência e a Tecnologia |
Portugal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone mineral density | Assayed by dual energy x-ray absorptiometry (DXA); g/cm2 | 12 months | |
Primary | Biochemical marker of bone resorption | Collagen type 1 cross-linked C-telopeptide (CTX; ng/mL) | 12 months | |
Primary | Bone Material Strength index (BMSi) | Normalized parameter of bone material's resistance to indentation (OsteoProbe RUO) | 12 months |
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