Time-Restricted Eating for Type II Diabetes: TRE-T2D

Korábbi kezelés

• Systolic BP greater than 160 mmHg and/or Diastolic BP greater than 110 mmHg (with or without treatment/medication)
• Active tobacco or illicit drug use
• Currently on a special or prescribed diet for other reasons (e.g., Celiac disease),
• The recent initiation, within the 3 preceding months prior to study enrollment, of medications designed for weight loss or with recognized appetite-suppressant effects (e.g. GLP-1 receptor agonists). Patients that are stable on such medications for at least 3 months can still be enrolled.

Más betegség

• History of eating disorder(s).
• History of surgical intervention for weight management (e) active eating disorder.
• Treatment for active inflammatory and/or rheumatologic disease and cancer.
• A major adverse cardiovascular event within the past 6 months such as acute coronary syndrome (ACS), percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack (TIA).
• History of Uncontrolled arrhythmia (i.e., rate-controlled atrial fibrillation/atrial flutter are not exclusion criteria)
• History of (a) 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),
• Known inflammatory and/or rheumatologic disease.
• History of major adverse cardiovascular events 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)).
• 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 stage 4 or 5 chronic kidney disease or requiring dialysis.
• History of HIV/AIDS.
• Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).

Laborértékek

• Participants with Type1DM and T2DM who are taking insulin, sulfonylureas, or have an HbA1c > 9 %.
• LDL cholesterol greater than 200 mg/dL
• Triglycerides greater than 500 mg/dL
• Chronic kidney disease with an eGFR calculated based on the Modification of Diet in Renal Disease (MDRD) equation < 30mL/min/1.73m2

Egyéb

• BMI > 50 kg/m2
• Pregnant or breastfeeding women.
• Currently enrolled in a weight-loss or weight-management program,
• Liver cirrhosis and/or significant alterations in liver function
• Shift workers with variable (e.g., nocturnal) hours.
• Caregivers for dependents requiring frequent nocturnal care/sleep interruptions.
• More than one trip planned to travel to a time zone with greater than a 3-hour difference during study period.

• Age: 18-75 years old
• Patients with T2DM with A1c between 6.5 and 9.0 % and on stable doses of medications who are weight-bearing and self-ambulatory.
• Own a smartphone (Apple iOS or Android OS)
• Baseline eating period ≥12 hours/day and sufficient logging on the mCC app.
• Women of childbearing age will be given a pregnancy test on study enrollment and asked to use contraception throughout the study.
• Post-menopausal and women on hormone replacement therapy will be included.
• Estimated Glomerular Filtration Rate (EGFR) > 30mL/min/1.73m2
• If participants are on cardiovascular medications (HMG CoA reductase inhibitors (statins), other lipid-modifying drugs, anti-hypertensives) no dose adjustments will be allowed during the study period
• Patients on stable doses of GLP-1 receptor agonists will be included.