Clinical trial NCT03329963: Lifestyle Intervention to Improve Bone Quality
Official title: Does Lifestyle Intervention Improve Bone Quality in Obese Older Adults?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Obesity
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Michael E. DeBakey VA Medical Center
name: Biomedical Research Institute of New Mexico
First posted: 2017-11-06
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Previous studies had suggested that lifestyle therapy (diet plus exercise) resulting in weight loss in elderly population improves physical function, cardio metabolic risk factors, and cognition/quality of life, but a major complication is loss of BMD. The addition of exercise to diet-induced weight loss attenuated but did not eliminate weight-loss-induced reduction of BMD. Moreover, while long-term maintenance of weight loss and physical function was feasible, sustained lifestyle change led to continued loss of hip BMD, which might predict hip fractures. Although similar BMD loss with weight loss has been observed in younger populations, BMD loss in older adults might be of particular concern because of aggravation of age-related bone loss. Moreover, the belief that obesity protects against fractures has now been challenged by studies demonstrating that obesity is associated with poor bone quality and ankle and leg fractures.Because of previous lack of options to assess bone quality in vivo, there has been little or no scientific study of the possibility that lifestyle therapy in obese older adults improves bone quality. This study represents an unprecedented opportunity to prove the hypothesis that lifestyle therapy intervention improves bone quality and thus, may confer a protective rather than adverse effect on bone health. This will be the first randomized controlled trial (RCT) to comprehensively assess bone quality using novel techniques in response to lifestyle therapy in obese older adults, with major ramifications with regards to defining optimal treatment strategies for this increasingly high-risk older population.

Eligibility criteria: Inclusion Criteria:

* Age 65 - 85 years • BMI 30 kg/m2 or more• 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

Primary outcomes:
measure: Change in cortical thickness
timeFrame: Change from baseline at 12 months
measure: Change in femoral bone strength
timeFrame: Change from baseline at 12 months
Secondary outcomes:
measure: Change in bone material strength
timeFrame: Change from baseline at 12 months
measure: Change in lower extremity strength
timeFrame: Change from baseline at 12 months
measure: Change in physical performance test
timeFrame: Change from baseline at 12 months
measure: Change in gait speed
timeFrame: Change from baseline at 12 months
measure: Change in handgrip strength
timeFrame: Change from baseline at 12 months
measure: Change in trabecular thickness
timeFrame: Change from baseline at 12 months
measure: Change in areal bone mineral density (BMD)
timeFrame: Change from baseline at 12 months
measure: Change in trabecular number
timeFrame: Change from baseline at 12 month
measure: Change in total volumetric BMD
timeFrame: Change from baseline at 12 months
measure: Change in cortical volumetric BMD
timeFrame: Change from baseline at 12 months
measure: Change in trabecular volumetric BMD
timeFrame: Change from baseline at 12 months
measure: Change in stiffness
timeFrame: Change from baseline at 12 months
measure: Change in trabecular separation
timeFrame: Change from baseline at 12 months
measure: Change in micro-finite element analyses strength
timeFrame: Change from baseline at 12 months
measure: Change in cortical porosity
timeFrame: Change from baseline at 12 months
measure: Change in general quality of life
timeFrame: Change from baseline at 12 months
measure: Change in obesity specific quality of life
timeFrame: Change from baseline at 12 months
measure: Change in mood
timeFrame: Change from baseline at 12 months
measure: Change in composite cognitive z-score
timeFrame: Change from baseline at 12 months
measure: Change in cardio metabolic risk factors
timeFrame: Change from baseline at 12 months
measure: Change in word list fluency
timeFrame: Change from baseline at 12 months
measure: Change in Ray Auditory verbal learning test
timeFrame: Change from baseline at 12 months
measure: Change in blood pressure
timeFrame: Change from baseline at 12 months
measure: Change in biochemical marker for bone turnover and bone metabolism
timeFrame: Change from baseline at 12 months
measure: Change in central volumetric BMD
timeFrame: Change from baseline at 12 months
measure: Change in waist circumference
timeFrame: Change from baseline at 12 months
measure: Change in lean mass
timeFrame: Change from baseline at 12 months
measure: Change in fat mass
timeFrame: Change from baseline at 12 months
measure: Change in visceral fat
timeFrame: Change from baseline at 12 months
measure: Change in physical activity using accelerometer
timeFrame: Change from baseline at 12 months
measure: Change in body weight
timeFrame: Change from baseline at 12 months
measure: Change in sclerostin
timeFrame: Change from baseline at 12 months
measure: Change in wnt signaling pathways
timeFrame: Change from baseline at 12 months
measure: Change in total body mass
timeFrame: Change from baseline at 12 months
measure: Change in hormones
timeFrame: Change from baseline at 12 months
measure: Change in thigh mass
timeFrame: Change from baseline at 12 months
measure: Change in circulating cytokines
timeFrame: Change from baseline at 12 months
measure: Change in adipocytokines
timeFrame: Change from baseline at 12 months
measure: Change in total volumetric BMD
timeFrame: Change from baseline at 12 months
measure: Change in cortical trabecular BMD
timeFrame: Change from baseline at 12 months
measure: Change in aerobic capacity
timeFrame: Change from baseline at 12 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E Debakey VA Medical Center
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Dennis T Villareal, MD
role: PRINCIPAL_INVESTIGATOR
References: