Status:
UNKNOWN
The Influence of Time-Restricted Eating in Patients With Metabolic Syndrome
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Salk Institute for Biological Studies
Conditions:
Metabolic Syndrome
Pre-Diabetes
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
In a randomized controlled trial, the investigators intend to measure the health impact of TRE in patients with metabolic syndrome (with three or more of the following criteria: increased waist circum...
Detailed Description
Circadian rhythms optimize nutrient homeostasis by orchestrating catabolic and anabolic metabolism to appropriate times of the 24 hour day. Chronic circadian rhythm disruption predisposes individuals ...
Eligibility Criteria
Inclusion
- Age 18-75 years
- 41 ≥ BMI ≥ 25 AND
- Metabolic syndrome, as defined as presence of 3 or more of the following criteria:
- Elevated fasting plasma glucose ≥ 100 mg/dL and/or HbA1c ≥ 5.7% \< 7.1% Elevated waist circumference: In Asians: ≥ 90 cm in men, ≥ 80 cm in women, all other races: ≥ 102 cm in men, ≥ 88 cm in women Fasting plasma triglycerides ≥ 150 mg/dL, or on drug treatment for elevated triglycerides Reduced High-density lipoprotein (HDL)-cholesterol \< 40 mg/dL in males or \< 50 mg/dL in females, or drug treatment for reduced HDL-cholesterol Elevated blood pressure, Systolic blood pressure ≥ 135 mm Hg and/or diastolic blood pressure ≥ 85 mm Hg or drug treatment for hypertension
- Own a smartphone (Apple iOS or Android OS)
- Baseline eating period ≥ 12 hour window
- 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, anti-diabetes drugs), no dose adjustments will be allowed during the study period.
Exclusion
- Taking insulin within the last 6 months.
- Manifest diabetes, defined as HbA1c \> 7.0% given a 0.3% margin of error in lab readings, or diagnosis of diabetes.
- Known inflammatory and/or rheumatologic disease.
- Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse.
- Pregnant or breast-feeding women.
- Shift workers with variable (e.g. nocturnal) hours.
- Caregivers for dependent requiring frequent nocturnal care/sleep interruptions.
- Planned travel to a time zone with greater than a 3-hour difference during study period.
- History of major adverse cardiovascular event within the past 1 year (acute coronary syndrome (ACS), percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack (TIA)).
- Uncontrolled arrhythmia (i.e. rate-controlled atrial fibrillation/atrial flutter are not exclusion criteria).
- History of thyroid disease 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 malignancy undergoing active treatment, except non-melanoma skin cancer.
- Known history of type I diabetes.
- History of eating disorder(s).
- History of cirrhosis.
- History of stage 4 or 5 chronic kidney disease or requiring dialysis.
- History of HIV/AIDS.
- Currently enrolled in a weight-loss or weight-management program.
- On a special or prescribed diet for other reasons (e.g. Celiac disease).
- Currently taking any medication that is meant for, or has known effect on, appetite.
- Any history of surgical intervention for weight management.
- Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
- A score of \>16 on the Epworth Sleepiness Scale (ESS).
- Depression determined by the Beck Depression Inventory (BDI) (unless previously diagnosed and well-controlled).
- Failure to use the smartphone app for documentation (defined as \<2 meals/day for ≥3 days during baseline).
Key Trial Info
Start Date :
April 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT04057339
Start Date
April 8 2019
End Date
June 1 2023
Last Update
April 6 2023
Active Locations (1)
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1
Altman Clinical and Translational Research Institute
La Jolla, California, United States, 92093