Status:
ACTIVE_NOT_RECRUITING
Effect of Time-restricted Eating on Catecholamine-sensitivity of Adipose Tissue in Obese Adults
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Salk Institute for Biological Studies
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In a randomized controlled trial, the investigators intend to measure the health impact of time-restricted eating (TRE) in obese patients (body mass index (BMI) ≥ 30 kg/m2), who habitually eat for mor...
Detailed Description
The current worldwide epidemic of obesity puts millions of people at increased risk for cardiovascular disease (CVD) and type 2 diabetes mellitus (T2DM), and while insulin resistance has been a tradit...
Eligibility Criteria
Inclusion
- Age: ≥ 18 years old
- BMI 30-50 kg/m2
- Own a smartphone with Apple iOS or Android OS
- Baseline eating window ≥ 14 hours/day
- If patients are on cardiovascular medications (HMG CoA reductase inhibitors (statins), other lipid modifying drugs (including over the counter drugs such as red yeast rice and fish oil), anti-hypertensive drugs, no dose adjustments will be allowed during the study period.
Exclusion
- Taking insulin or anti-diabetic medications within the last 6 months.
- Manifest diabetes, defined as fasting glucose ≥ 126 mg/dL, HbA1c ≥ 6.5%, or diagnosis of diabetes.
- Currently taking any medication that is meant for, or has known effect on, appetite or body weight
- Pregnant or breast-feeding women.
- Caregiver for a dependent requiring frequent nocturnal care/sleep interruptions. Shift workers with variable (e.g. nocturnal) hours.
- Planned international travel (time zone changes) during study period.
- Taking therapeutic anticoagulation which might increase risk of bleeding from adipose tissue biopsy
- History of surgical intervention for weight loss.
- History of eating disorder
- Currently enrolled in a weight-loss or weight-management program
- On a special or prescribed diet for other reasons (e.g. Celiac disease)
- Known inflammatory and/or rheumatologic disease
- Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse
- History of bone marrow or solid organ transplant
- History of heart failure
- History of major adverse cardiovascular events (acute coronary syndrome (ACS), percutaneous coronary intervention, coronary artery bypass graft surgery, stroke/transient ischemic attack (TIA)).
- History of atrial fibrillation or atrial flutter
- History of malignancy, other than non-melanoma skin cancer, that is currently being treated, or that has not been treated with definitive therapy and considered to be in remission.
- History of hypo- or hyperthyroidism requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e. hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion)
- History of adrenal disease
- History of cirrhosis
- History of stage 4 or 5 chronic kidney disease or requiring dialysis
- History of HIV/AIDS
- Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
- History of obstructive sleep apnea (not on stable positive pressure therapy or other treatment for at least 3 months prior to enrollment)
- Abnormal screening labs: renal dysfunction (eGFR \< 30 ml/min/1.73 m2), anemia, hypo- or hyperthyroidism, coagulopathy, abnormal liver function (AST, ALT \> 3x upper limit of normal)
Key Trial Info
Start Date :
December 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04916730
Start Date
December 17 2020
End Date
January 1 2026
Last Update
October 14 2025
Active Locations (1)
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1
Altman Clinical and Translational Research Institute
La Jolla, California, United States, 92093