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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT05653258
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Lifestyle Intervention — OTHER
    1. Exercise: Subjects will undergo a combined aerobic and resistance exercise intervention. The investigators propose a multi-modal training program because they improve metabolic outcomes and adding resistance training reduces the risk of muscle loss during weight loss. Subjects will exercise in the gym for three sessions per week for 10 weeks under supervision of an exercise physiologist. On each session, aerobic exercise will be followed by resistance exercise. 2. Diet: The aim of the dietary intervention is to reduce caloric intake sufficient to result in 8-10% weight loss, while incorporating behavioral and dietary strategies to maximize adherence and to minimize risk of muscle and bone loss. Subjects will attend small-group sessions led by a dietitian for changing their dietary composition to follow American Heart Association (AHA)/American College of Cardiology (ACC) guidelines.
  • Dasatinib 100 MG — DRUG
    100 mg of dasatinib (D) daily for 3 consecutive days plus quercetin (Q) for the same 3 consecutive days, followed by a 25-day (+/- 2 day) no-drug period to complete a single round. This will be repeated twice more until completing 3 rounds total in approximately 10 consecutive weeks.
  • Quercetin 1000mg — DRUG
    Quercetin (Q) (4) 250 mg capsules daily (total 1000 mg daily) plus dasatinib (D) same 3 consecutive days, followed by a 25-day (+/- 2 day) no-drug period to complete a single round. This will be repeated twice more until completing 3 rounds total in approximately 10 consecutive weeks.
  • Placebo — DRUG
    Subjects will receive a placebo (methylcellulose) to provide a similar mass, number of tablets/ capsules, and frequency as the senolytic arm.
  • Abdominal adipose tissue biopsy — PROCEDURE
    All participants will undergo baseline biopsies of subcutaneous abdominal adipose tissue for cellular/molecular profiling via snRNA-seq

Study Details

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 Dates

Start date
Oct 17, 2023
Status verified
Mar 2026
Primary completion
Feb 1, 2027
Completion
Feb 1, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Insulin sensitivity [ Time Frame: Week 4 and Week 15 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048
Nicolas Musi
[email protected]
12106305001
Sandra Gomez
[email protected]
210-777-0629

Find similar trials in Los Angeles, CA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Cedars Sinai Medical Center· Los Angeles, CA

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