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New treatment option for Metabolic Syndrome
Official title Long Term Impact of Time-Restricted Eating on Parameters of Cardiometabolic Health
ClinicalTrials.gov ID: NCT07189234
What this study is testing
- What it's testing
- In a randomized controlled trial, the investigators intend to measure the health impact of time restricted eating (TRE) in patients with metabolic syndrome (with elevated blood pressure and at least 2 of the following: increased waist circumference, abnormal cholesterol levels, elevated triglycerides, and elevated fasting glucose levels), who habitually eat more than 12 hours every day. Patients will be randomly assigned to a control group (standard of care) or intervention group (TRE).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age: 18-75 years
- HbA1c: 5.7% to 7.0%
- Metabolic syndrome (must meet 3 criteria):
- Elevated systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 85 mm Hg OR an antihypertensive therapy)
- Elevated waist circumference: \- In Asians: ≥ 90 cm in men, ≥80 cm in women In all other races: ≥ 102 cm in men, ≥ 88 cm in women
You likely can't join if
- Use of sulfonylurea or insulin.
- HbA1C \> 7.0%
- Pregnant or breastfeeding. Anyone of reproductive age will receive pregnancy test prior to DXA scan.
- Caregiver for a dependent requiring frequent nocturnal care / sleep interruptions.
- Shift workers with variable (e.g. nocturnal) hours.
- Frequent travel to different time zones during the study period.
See the full eligibility criteria
- Age: 18-75 years
- HbA1c: 5.7% to 7.0%
- Metabolic syndrome (must meet 3 criteria):
- Elevated systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 85 mm Hg OR an antihypertensive therapy)
- Elevated waist circumference: \- In Asians: ≥ 90 cm in men, ≥80 cm in women In all other races: ≥ 102 cm in men, ≥ 88 cm in women
- Fasting plasma triglycerides ≥ 150 mg/dL, or on drug treatment for elevated triglycerides d) Reduced High-density lipoprotein (HDL)- cholesterol \< 40 mg/dL in males or \< 50 mg//dL in females, or drug treatment for...
- Own a smartphone (Apple iOS or Android OS)
- Baseline eating period ≥12 hour/day
- Patients on a stable dose of cardiovascular medications (HMG CoA reductase inhibitors [statins]), other lipid-modifying drugs (including over-the-counter drugs such as red yeast rice and fish oil), or anti-hypertensive...
- Patients on GLP-1 R agonists, SGLT2 inhibitors, or Metformin must be on stable doses for at least 3 months.
- Use of sulfonylurea or insulin.
- HbA1C \> 7.0%
- Pregnant or breastfeeding. Anyone of reproductive age will receive pregnancy test prior to DXA scan.
- Caregiver for a dependent requiring frequent nocturnal care / sleep interruptions.
- Shift workers with variable (e.g. nocturnal) hours.
- Frequent travel to different time zones during the study period.
- Active tobacco use or illicit drug use or history of treatment for alcohol abuse.
- History of major adverse cardiovascular event within the past year (acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure...
- History of surgical intervention for weight management within the past 2 years, or longer if deemed unsafe following review by medical investigators
- 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 1 diabetes.
- History of an eating disorder.
- History of cirrhosis.
- History of stage 4 or 5 chronic kidney disease or requiring dialysis.
- Currently enrolled in a weight-loss or weight-management program.
- On a special or prescribed diet for other reasons (e.g. Celiac disease).
- Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
- Inability or unwillingness to utilize the mCC app throughout study duration.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.