An observational study in Weight Loss, Obesity and Aging, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-15.
Sponsored by Wake Forest University Health Sciences · Observational
Among 45 studies in Obesity by Wake Forest University Health Sciences — 3 open to participants now, 4 under way, 1 of them phase 3. Obesity · Wake Forest University Health Sciences.
Among the 45 studies in Obesity by Wake Forest University Health Sciences, this one is one of 4 that started in 2018, is one of 6 observational ones, and was the 34th registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →3 of the 45 studies in Obesity by Wake Forest University Health Sciences are open now, in 1 country. Recruiting first, the newest first:
Wake Forest University Health Sciences · Sites in United States
Wake Forest University Health Sciences · Sites in United States
Wake Forest University Health Sciences · Sites in United States
By country, each count listing its studies:
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 60 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
45 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 4 started in 2018.
This study's enrollment of 588 is above the median of 114 across 2,154 observational studies indexed under Obesity.
Median enrollment 88 across the 39 interventional studies, 87 across the 6 observational. Of the 40 that completed or were terminated, 16 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
2 of the studies in Obesity by Wake Forest University Health Sciences that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05674799Wake Forest University Health SciencesNDPP-NextGen: A Clinical Trial to Reduce Intergenerational Obesity and Diabetes Risks | 2027-05-31 |
| NCT06861439Wake Forest University Health SciencesGLP-1s to Enhance Lasting Optimal Weight | 2027-10-30 |
Among the 45 studies in Obesity by Wake Forest University Health Sciences, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 588 is above the median of 114 across 2,154 observational studies indexed under Obesity.
Browse Obesity studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Weight Loss. The counts are of registry records indexed under each term, refreshed daily. How we classify →
All participants aged 60 and older at randomization who were randomized to a weight loss intervention that was combined with an exercise intervention (WL+EX, n=392), to an exercise intervention alone (EX alone, n=340), to a weight loss intervention alone (n=128), or to a control group (n=106) from five weight loss and exercise randomized controlled trials.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This group was randomized and previously assigned to weight loss plus exercise.
This group was randomized and previously assigned to exercise alone.
This group was randomized and previously assigned to weight loss alone.
This group was randomized and previously assigned to control.
400 meter walk time
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.
Time frame: Baseline
Short Physical Performance Battery score
The Short Physical Performance Battery (SPPB) is a widely used assessment of lower extremity physical function that consists of 3 standing balance tasks held for 10 seconds each (side-by-side, tandem and semi-tandem), two 4-m walk tests to assess usual gait speed, and 5 repeated chair stands. Each of the three performance measures is assigned a score ranging from 0 (inability to do the test) to 4 (the highest level of performance) and summed to create an SPPB summary score ranging from 0 (worst) to 12 (best).
Time frame: Baseline
Knee extension strength
Maximal isokinetic knee extension strength. Maximal isokinetic knee extension strength will be measured using an isokinetic dynamometer (Biodex) at 60°/sec with the participant sitting and the hips and knee flexed at 90°. The maximum knee extensor strength of the 4 repetitions from trial 2 for the dominant leg will be will be used in analyses unless unable to test the dominant leg (i.e., knee replacement) in which case the non-dominant leg will be used.
Time frame: Baseline
Total body lean mass
Whole body lean mass will be measured by dual-energy X-ray absorptiometry (DXA).
Time frame: Baseline
Appendicular lean mass
Appendicular lean mass will be measured by DXA.
Time frame: Baseline
Total body fat mass
Whole body fat mass will be measured by DXA.
Time frame: Baseline
Total hip BMD
Bone mineral density (BMD) of the total hip will be measured by DXA.
Time frame: Baseline
Femoral neck BMD
Bone mineral density (BMD) of the femoral neck will be measured by DXA.
Time frame: Baseline
Lumbar spine BMD
Bone mineral density (BMD) of the lumbar spine (L1-L4) will be measured by DXA.
Time frame: Baseline
Subcutaneous abdominal fat
Subcutaneous abdominal fat will be measured by computed tomography (CT).
Time frame: Baseline
Visceral abdominal fat
Visceral abdominal fat will be measured by CT.
Time frame: Baseline
Thigh inter-muscular adipose tissue
Thigh inter-muscular adipose tissue will be measured by CT.
Time frame: Baseline
Glucose
Assessed via a standard clinical assay after fasting for at least 8 hours.
Time frame: Baseline
Insulin
Assessed via a standard clinical assay after fasting for at least 8 hours.
Time frame: Baseline
Total cholesterol
Assessed via a standard clinical lipid panel after fasting for at least 8 hours
Time frame: Baseline
HDL cholesterol
Assessed via a standard clinical lipid panel after fasting for at least 8 hours
Time frame: Baseline
LDL cholesterol
Assessed via a standard clinical lipid panel after fasting for at least 8 hours
Time frame: Baseline
Triglycerides
Assessed via a standard clinical lipid panel after fasting for at least 8 hours
Time frame: Baseline
Systolic blood pressure
Blood pressure will be measured in the right arm using an automated sphygmomanometer with the participant in a seated position after having rested quietly for 10-15 minutes. Participants will sit with feet flat on the floor and legs uncrossed and will be asked not to talk during the rest period or during the measurement. Systolic blood pressure will be defined as the average of three repeated measures.
Time frame: Baseline
Diastolic blood pressure
Blood pressure will be measured in the right arm using an automated sphygmomanometer with the participant in a seated position after having rested quietly for 10-15 minutes. Participants will sit with feet flat on the floor and legs uncrossed and will be asked not to talk during the rest period or during the measurement. Diastolic blood pressure will be defined as the average of three repeated measures.
Time frame: Baseline
C-reactive protein
C-reactive protein (CRP) will be determined using an automated immunoanalyzer.
Time frame: Baseline
Interleukin-6
Interleukin-6 (IL-6) will be assayed with high-sensitivity Quantikine®.
Time frame: Baseline
Soluble tumor necrosis factor receptor 1
Soluble tumor necrosis factor receptor 1 (sTNFR1) will be assayed with high-sensitivity Quantikine®.
Time frame: Baseline
Ran from Feb 2018 to primary completion in Jul 2021, 41 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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