Single Nuclei RNA-seq to Map Adipose Cellular Populations and Senescent Cells in Older Subjects (NCT05653258) | Clinical Trial Compass
RecruitingPhase 2/3
Single Nuclei RNA-seq to Map Adipose Cellular Populations and Senescent Cells in Older Subjects
United States160 participantsStarted 2023-10-17
Plain-language summary
All participants will undergo baseline biopsies of subcutaneous abdominal adipose tissue for cellular/molecular profiling via snRNA-seq and metabolic/physiological assessments (insulin sensitivity, glucose tolerance, and β-cell function). Older obese participants will be randomized into three arms: lifestyle intervention (n=24), senolytics (n=24), or placebo (n=24).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Both Sexes
✓. Age: younger lean group 18-30 years with BMI 18.5-24.9 kg/m2; younger obese group 18-30 with BMI 30.0 -39.9; older obese group ≥ 65 years with BMI 30.0-39.9
✓. All races and ethnic groups
✓. Community dwelling
✓. Sedentary (≤1.5 h of exercise per week)
✓. Nondiabetic (fasting plasma glucose \< 126 mg/dl, 2-h glucose during oral glucose tolerance test (OGTT) \< 140mg/dl, and A1c \< 6.5%
✓. For all female participants who are women of childbearing potential (WOCBP), who are not pregnant or breast feeding, at least one of the following conditions must apply:
✓. ECG value after 10 minutes of resting in the supine position in the following ranges:
Exclusion criteria
✕. Diabetes, clinically diagnosed or HbA1c \> 6.5% and/or fasting plasma glucose \> 126 mg/dl and/or use of anti-diabetic medications.
✕. Participating in \> 1.5 h of structured exercise/week
✕. Unstable weight (\>3% change in last 3 months)
✕. Neurological, musculoskeletal, or other conditions that may limit subject's ability to complete study physical assessment and training