Obesity Clinical Trial
— LIMB-QOfficial title:
Does Lifestyle Intervention Improve Bone Quality in Obese Older Adults?
Verified date | March 2024 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Obese older adults will be randomized to participate in either healthy lifestyle intervention or behavioral diet and exercise intervention for one year. This study aims to determine the effects of Lifestyle intervention on bone microarchitecture, bone strength, bone material properties, and the mechanism behind it.
Status | Active, not recruiting |
Enrollment | 120 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years to 85 Years |
Eligibility | Inclusion Criteria: - Age 65 - 85 years • BMI 30 - 40 kg/m2 • Stable body weight (±2 kg) during the past 6 months • Sedentary (regular exercise <1 h/wk. or <2 x/wk. for the last 6 months) • Willing to provide informed consent Exclusion Criteria: - Failure to provide informed consent. - Any major chronic diseases, or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restrictions are contraindicated, or that would interfere with interpretation of results - Cardiopulmonary disease (e.g. recent myocardial infarction, unstable angina, stroke) or unstable disease (e.g., New York Heart Class III or IV congestive heart failure, severe pulmonary disease requiring steroid pills or the use of supplemental oxygen ) that would contraindicate exercise or dietary restriction - Severe orthopedic (e.g. awaiting joint replacement) and/or neuromuscular (e.g. multiple sclerosis, amyotrophic lateral sclerosis, active rheumatoid arthritis) disease or impairments that would contraindicate participation in exercise - Other significant co-morbid disease that would impair ability to participate in the exercise-based intervention (e.g. renal failure on hemodialysis, severe psychiatric disorder [e.g. bipolar, schizophrenia], excess alcohol use [more than14 drinks per week]) - Severe visual or hearing impairments that would interfere with following directions - Significant cognitive impairment, defined as a known diagnosis of dementia or positive screening test for dementia using the Mini-Mental State Exam score less than 24) - Uncontrolled hypertension (BP>160/90 mm Hg) - History of malignancy during the past 5 years (except non-melanoma skin cancers) - Current use of bone acting drugs (e.g. use of estrogen, or androgen containing compound, raloxifene, calcitonin, parathyroid hormone during the past year or bisphosphonates during the last two years) - Osteoporosis (T-score -2.5 and below on hip or spine scan) or history of fragility fractures - Diabetes mellitus requiring insulin for treatment or with a fasting blood glucose of >140 mg/dl, and/or HbA1c >8.5% (Those excluded from the study because of fasting blood glucose of >140 mg/dl or HbA1c>8.5% will be referred to their primary care provider for follow-up and appropriate treatment). - Terminal illness with life expectancy less than 12 months, as determined by a physician - Use of any drugs or natural products designed to induce weight loss within past three months. - Positive exercise stress test for ischemia |
Country | Name | City | State |
---|---|---|---|
United States | Michael E Debakey VA Medical Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine | Biomedical Research Institute of New Mexico, Michael E. DeBakey VA Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in cortical thickness | Assessed by using high-resolution peripheral computed tomography (HR-pQCT) | Change from baseline at 12 months | |
Primary | Change in femoral bone strength | Assessed by using finite element analyses (FEA) of quantitative computed tomography (QCT) | Change from baseline at 12 months | |
Secondary | Change in bone material strength | Assessed by using microindentation testing | Change from baseline at 12 months | |
Secondary | Change in lower extremity strength | Assessed by using a Biodex dynamometer | Change from baseline at 12 months | |
Secondary | Change in physical performance test | assessed by using the objective physical performance test | Change from baseline at 12 months | |
Secondary | Change in gait speed | as measured by completing the time to walk a certain distance | Change from baseline at 12 months | |
Secondary | Change in handgrip strength | Measured by hydraulic hand dynamometer | Change from baseline at 12 months | |
Secondary | Change in trabecular thickness | Assessed by using HR-pQCT | Change from baseline at 12 months | |
Secondary | Change in areal bone mineral density (BMD) | Assessed by using dual-energy x-ray absorptiometry | Change from baseline at 12 months | |
Secondary | Change in trabecular number | Assessed by using HR-pQCT | Change from baseline at 12 month | |
Secondary | Change in total volumetric BMD | Assessed by using HR-pQCT | Change from baseline at 12 months | |
Secondary | Change in cortical volumetric BMD | Assessed by using HR-pQCT | Change from baseline at 12 months | |
Secondary | Change in trabecular volumetric BMD | Assessed by using HR-pQCT | Change from baseline at 12 months | |
Secondary | Change in stiffness | Assessed by using HR-pQCT | Change from baseline at 12 months | |
Secondary | Change in trabecular separation | Assessed by using HR-pQCT | Change from baseline at 12 months | |
Secondary | Change in micro-finite element analyses strength | Assessed by using HR-pQCT | Change from baseline at 12 months | |
Secondary | Change in cortical porosity | Assessed by using HR-pQCT | Change from baseline at 12 months | |
Secondary | Change in general quality of life | Assessed by using the Short Form-36 questionnaire | Change from baseline at 12 months | |
Secondary | Change in obesity specific quality of life | Assessed by using the Impact of weight on quality of life short form (IWQOL-Lite) questionnaire | Change from baseline at 12 months | |
Secondary | Change in mood | Assessed by using a mood scale questionnaire | Change from baseline at 12 months | |
Secondary | Change in composite cognitive z-score | Using cognitive instrument testing | Change from baseline at 12 months | |
Secondary | Change in cardio metabolic risk factors | Assessed by measuring metabolic syndrome components | Change from baseline at 12 months | |
Secondary | Change in word list fluency | Assessed by using cognitive instrument testing | Change from baseline at 12 months | |
Secondary | Change in Ray Auditory verbal learning test | Assessed by using cognitive instrument testing | Change from baseline at 12 months | |
Secondary | Change in blood pressure | Assessed by usingSphygmomanometer | Change from baseline at 12 months | |
Secondary | Change in biochemical marker for bone turnover and bone metabolism | Assessed by using enzyme linked immunosorbent assay and radioimmunoassay | Change from baseline at 12 months | |
Secondary | Change in central volumetric BMD | Assessed by using CT scan at the spine and hip | Change from baseline at 12 months | |
Secondary | Change in waist circumference | Assessed by using tape measurement | Change from baseline at 12 months | |
Secondary | Change in lean mass | Assessed by using dual-energy x-ray absorptiometry | Change from baseline at 12 months | |
Secondary | Change in fat mass | Assessed by using dual-energy x-ray absorptiometry | Change from baseline at 12 months | |
Secondary | Change in visceral fat | Assessed by using dual-energy x-ray absorptiometry | Change from baseline at 12 months | |
Secondary | Change in physical activity using accelerometer | Assessed by using an accelerometer | Change from baseline at 12 months | |
Secondary | Change in body weight | Assessed by using weighing scale | Change from baseline at 12 months | |
Secondary | Change in sclerostin | Assessed by using enzyme linked immunoassay | Change from baseline at 12 months | |
Secondary | Change in wnt signaling pathways | Assessed by measurements of circulating levels of Wnt 5a and Sfrp5 | Change from baseline at 12 months | |
Secondary | Change in total body mass | Assessed byusing dual energy x-ray absorptiometry | Change from baseline at 12 months | |
Secondary | Change in hormones | Assessed by usingenzyme link immunoassay | Change from baseline at 12 months | |
Secondary | Change in thigh mass | Assessed by using CT scan | Change from baseline at 12 months | |
Secondary | Change in circulating cytokines | Assessed by using enzyme linked immunoassay | Change from baseline at 12 months | |
Secondary | Change in adipocytokines | Assessed by using enzyme linked immunoassay | Change from baseline at 12 months | |
Secondary | Change in total volumetric BMD | Assessed by using QCT Pro software | Change from baseline at 12 months | |
Secondary | Change in cortical trabecular BMD | Assessed by using QCT Pro software | Change from baseline at 12 months | |
Secondary | Change in aerobic capacity | Assessed by using indirect calorimetry during graded treadmill test | Change from baseline at 12 months |
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