Single Nuclei RNA-seq to Map Adipose Cellular Populations and Senescent Cells in Older Subjects

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Obesity, Healthy Lifestyle

In brief

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).

Key facts

Study ID: NCT05653258
Run by: Cedars-Sinai Medical Center
People needed: 160
Starts: 2023-10-17
Expected to finish: 2028-02-01
Last updated by the study team: 2026-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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:
A documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy Use of a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency (implantable progesterone-only hormone contraception, intrauterine hormone releasing system, bilateral tubal occlusion, vasectomized partner) during the intervention period of the study and for at least 30 days after the last dose of study intervention to eliminate any reproductive safety risk of the study drug.
Use of a contraceptive method that is highly effective (with a failure rate of <1% per year), with high user dependency, (oral/intravaginal/injectable combined estrogen and progesterone contraception, oral/injectable progesterone only hormone contraception, sexual abstinence) during the intervention period and for at least 30 days after the last dose of study intervention to eliminate any reproductive safety risk of the study drug. In addition to the highly effective methods: male or female condom with or without spermicide; cervical cap, diaphragm, or sponge with spermicide; a combination of male condom with either cervical cap, diaphragm, or sponge with spermicide.
ECG value after 10 minutes of resting in the supine position in the following ranges:
120ms<PR<220ms: QRS<120ms; QTc<430ms for males and QTc<450ms for females and normal ECG tracing, unless the investigator considers the ECG abnormality to be not clinically relevant.

You may not qualify if…

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
Active autoimmune/inflammatory disease including: rheumatoid arthritis, multiple sclerosis, systemic lupus erythematous, inflammatory bowel disease
Laboratory parameters outside the normal range:
impaired kidney function (eGFR < 30ml/min/1.73m² as calculated by the CKD-EPI equation);
impaired liver function (AST or ALT level > 2 times upper limit of normal (ULN);
total Bilirubin level > 1.5 times ULN;
TSH > 1.5 times ULN or < lower limit of normal (LLN);
Hemoglobin <10.0 g/dl; Platelets <125,000 cell/mm³;
Platelets < 125,000 cell/mm³
Prothrombin time (PT) > 1.0 times ULN
Partial prothrombin time (PTT) > 1.0 times ULN.
Active gastrointestinal disease; coagulopathy; GI bleed within 6 months
Clinically significant heart disease (e.g. NYH Classification >II; ischemia)
Peripheral vascular disease (claudication)
QTc prolongation >45 msec
Use of anti-arrhythmic medications known to cause QTc prolongation, anti-platelet or anti-coagulant medication (see section 5.3)
Use of quinolone antibiotics or any other drugs that may prolong the QTc interval (see section 5.3)
Pulmonary disease (COPD), severe asthma or exercise-induced asthma
Recent systemic or pulmonary embolus
Uncontrolled blood pressure (systolic BP>170, diastolic BP>95 mmHg)
Smoking, alcohol use (history of regular alcohol consumption exceeding 7 drinks/week for female participants or 14 drinks/week for male participants. 1 drink = 5 ounces [150ml] of wine or 12 ounces [360ml] of beer or 1.5 ounces [45ml] of hard liquor) or recreational drug use (other than marijuana)
Pregnant or breastfeeding

Where it is running

Cedars Sinai Medical Center — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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