RecruitingPhase 2 / Phase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 7 days
  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
  • "Each subject will be provided an accelerometer to be worn on their dominant wrist for 7 days for assessment of habitual activity."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at cells in belly fat and how the body handles blood sugar in younger and older adults without diabetes. Everyone will have a small fat sample taken from under the skin and tests of blood sugar control. Older adults with obesity will be assigned by chance to lifestyle changes, drugs that target aging cells, or a placebo (an inactive treatment).

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Ages 18–30 with BMI 18.5–24.9 or 30.0–39.9, or age 65 or older with BMI 30.0–39.9. BMI is a measure of weight compared with height.
  • People of both sexes and all races and ethnic groups may join.
  • Live in the community.
  • Exercise no more than 1.5 hours per week.
  • Have no diabetes: fasting blood sugar below 126 mg/dL, blood sugar below 140 mg/dL two hours after a sugar drink, and A1c below 6.5%. A1c measures average blood sugar.
  • Women who could become pregnant must not be pregnant or breastfeeding and must meet the study's surgery or highly effective birth control rules. Required birth control must continue through 30 days after the last study dose.
  • Have a heart tracing (ECG) after resting flat for 10 minutes that meets the study's timing limits. Other changes may be allowed if the study doctor finds they are not medically important.

Who can't join

  • Diabetes or use of diabetes drugs; more than 1.5 hours of planned exercise weekly; weight change greater than 3% in the last 3 months; or conditions that limit physical testing or training.
  • Active disease that causes the immune system to attack the body or causes inflammation; any short-term or ongoing infection; or cancer treated in the last 3 years, except basal cell skin cancer.
  • Kidney, liver, thyroid, blood count, or blood-clotting tests outside the study's limits; active stomach or bowel disease; a clotting disorder; or stomach or bowel bleeding in the last 6 months.
  • Serious heart disease, poor blood flow to the legs, certain heart tracing changes, a recent blood clot that traveled through the body or lungs, or blood pressure above 170 systolic or 95 diastolic.
  • COPD (a long-term lung disease), severe asthma, asthma brought on by exercise, or a past stroke that limits movement.
  • Smoking; more than 7 alcoholic drinks weekly for women or 14 for men; recreational drugs other than marijuana; pregnancy or breastfeeding; hormone replacement therapy started within 6 months after menopause; or past weight-loss surgery.
  • Use of drugs that affect heart rhythm or prevent blood clots; weight-loss drugs, whole-body steroids, immune-suppressing drugs, or certain drugs or supplements that target aging cells within 6 months.
  • Allergy to dasatinib, quercetin, or lidocaine; or taking part in another study that assigns a treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Both Sexes 2. 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 3. All races and ethnic groups 4. Community dwelling 5. Sedentary (≤1.5 h of exercise per week) 6. Nondiabetic (fasting plasma glucose \< 126 mg/dl, 2-h glucose during oral glucose tolerance test (OGTT) \< 140mg/dl, and A1c \< 6.5% 7. 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. 8. 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. Exclusion Criteria: 1. Diabetes, clinically diagnosed or HbA1c \> 6.5% and/or fasting plasma glucose \> 126 mg/dl and/or use of anti-diabetic medications. 2. Participating in \> 1.5 h of structured exercise/week 3. Unstable weight (\>3% change in last 3 months) 4. Neurological, musculoskeletal, or other conditions that may limit subject's ability to complete study physical assessment and training 5. Active autoimmune/inflammatory disease including: rheumatoid arthritis, multiple sclerosis, systemic lupus erythematous, inflammatory bowel disease 6. 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. 7. Active gastrointestinal disease; coagulopathy; GI bleed within 6 months 8. Clinically significant heart disease (e.g. NYH Classification \>II; ischemia) 9. Peripheral vascular disease (claudication) 10. QTc prolongation \>45 msec 11. Use of anti-arrhythmic medications known to cause QTc prolongation, anti-platelet or anti-coagulant medication (see section 5.3) 12. Use of quinolone antibiotics or any other drugs that may prolong the QTc interval (see section 5.3) 13. Pulmonary disease (COPD), severe asthma or exercise-induced asthma 14. Recent systemic or pulmonary embolus 15. Uncontrolled blood pressure (systolic BP\>170, diastolic BP\>95 mmHg) 16. 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) 17. Pregnant or breastfeeding 18. Postmenopausal women new (within 6 months) to systemic hormone replacement therapy 19. Previous bariatric surgery 20. History of stroke with motor disability 21. Recent (3 years) treated cancer other than basal cell carcinoma 22. Acute or chronic infection 23. Medication that might interfere with metabolic studies (weight loss medication, systemic steroids, immunosuppressants) within 6 months (see section 5.3) 24. Potentially senolytic agents within the last 6 months: fisetin, quercetin, luteolin, dasatinib, piperlongumine, or navitoclax (see section 5.3) 25. History of allergy to dasatinib, quercetin and/or lidocaine. 26. Concurrent enrollment in another interventional trial.

Study sites (1)

CA