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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other, Procedure
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
California
Cedars Sinai Medical Center
RECRUITING
Los Angeles
Contact Information
Primary
Nicolas Musi, MD
nicolas.musi@cshs.org
210-562-6140
Backup
Arianne Aslamy, MD
Arianne.Aslamy@cshs.org
424-315-0685
Time Frame
Start Date: 2023-10-17
Estimated Completion Date: 2027-02
Participants
Target number of participants: 160
Treatments
Other: Younger Lean Group
Participants will be aged 18-30 years and have a BMI of 18.5 - 24.9 kg/m2
Other: Older Lean Group
Participants will be over 65 years of age with a BMI of 18.5 to 24.9 kg/m2
Experimental: Older Obese Group
Participants will be over 65 years of age with a BMI of 30-39.9 kg/m2.
Experimental: Younger Obese Group
Participants will be ages 18-30 years and have a BMI OF 30.0-39.9 kg/m2
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Aging (NIA)
Leads: Cedars-Sinai Medical Center

This content was sourced from clinicaltrials.gov