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Clinical Trials/NCT03430115
NCT03430115
Completed
Not Applicable

Long-term Function and Health Effects of Intentional Weight Loss in Obese Elders

Wake Forest University Health Sciences1 site in 1 country588 target enrollmentFebruary 20, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Weight Loss
Sponsor
Wake Forest University Health Sciences
Enrollment
588
Locations
1
Primary Endpoint
400 meter walk time
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Aging is associated with significant declines in muscle mass, strength, and physical performance, all of which lead to disability, loss of independence, and adverse clinical outcomes. Obesity exacerbates these age-related declines in function and is associated with poorer clinical outcomes and quality of life. Weight loss can also worsen age-related loss of muscle mass and decrease bone mineral density. The overall goals of this study are to determine if the short-term functional benefits of intentional weight loss are sustained long-term, and to examine the long-term benefits and risks of weight loss.

Detailed Description

Obesity exacerbates age-related declines in function and is associated with poorer clinical outcomes and quality of life. Although clinical trials conducted study teams show that diet-induced weight loss interventions in obese older adults, when combined with exercise, improve body composition and physical and metabolic function in the short-term, the overall safety and long-term benefits of intentional weight loss in older adults remain controversial. Weight loss can also worsen age-related loss of muscle mass and decrease bone mineral density. Because of these concerns, health care providers are reluctant to recommend weight loss in obese older adults. The goal is to determine whether weight loss-induced improvements in body composition and physical and metabolic function observed in short-term clinical trials persist over time is critical to inform geriatric obesity treatment.

Registry
clinicaltrials.gov
Start Date
February 20, 2018
End Date
July 27, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All former participants from the five intervention trials who respond to our recruitment strategies will be scheduled for clinic/home visits or a phone interview.

Exclusion Criteria

  • None - all former participants from the five intervention trials are eligible

Outcomes

Primary Outcomes

400 meter walk time

Time Frame: Baseline

Participants are instructed to complete the 400 m distance (on a flat indoor surface) as quickly as possible at a maintainable pace and the time to complete the walk is recorded in seconds.

Secondary Outcomes

  • Knee extension strength(Baseline)
  • Total body fat mass(Baseline)
  • Subcutaneous abdominal fat(Baseline)
  • Appendicular lean mass(Baseline)
  • Interleukin-6(Baseline)
  • Glucose(Baseline)
  • Insulin(Baseline)
  • LDL cholesterol(Baseline)
  • Short Physical Performance Battery score(Baseline)
  • Total body lean mass(Baseline)
  • Femoral neck BMD(Baseline)
  • Lumbar spine BMD(Baseline)
  • Visceral abdominal fat(Baseline)
  • Diastolic blood pressure(Baseline)
  • Soluble tumor necrosis factor receptor 1(Baseline)
  • Total hip BMD(Baseline)
  • Thigh inter-muscular adipose tissue(Baseline)
  • Total cholesterol(Baseline)
  • Systolic blood pressure(Baseline)
  • HDL cholesterol(Baseline)
  • Triglycerides(Baseline)
  • C-reactive protein(Baseline)

Study Sites (1)

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