Diabetes Mellitus, Type 2 Clinical Trial
— TRE-T2DOfficial title:
Feasibility and Efficacy of Time-Restricted Eating in Diabetes Management
NCT number | NCT05365529 |
Other study ID # | 801955 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 16, 2022 |
Est. completion date | March 2026 |
This is a randomized clinical trial to assess the feasibility and efficacy of time-restricted eating (TRE) to improve glucose regulation and cardiovascular health of participants with type 2 diabetes mellitus (T2DM). Participants will be randomized into 2 groups: 1) standard of care (SOC), in which they will continue to follow their physician's treatment plan, or 2) SOC and TRE (8-10 hours eating window).
Status | Recruiting |
Enrollment | 60 |
Est. completion date | March 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Age: 18-70 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) > 50 - 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. Exclusion Criteria: - Participants with Type1DM and T2DM who are taking insulin, sulfonylureas, or have an HbA1c > 9 %. - BMI > 40 kg/m2 - Systolic BP greater than 160 mmHg and/or Diastolic BP greater than 110 mmHg (with or without treatment/medication) - LDL cholesterol greater than 200 mg/dL - Triglycerides greater than 500 mg/dL - Active tobacco or illicit drug use - Pregnant or breastfeeding women. - Currently enrolled in a weight-loss or weight-management program, - Currently on a special or prescribed diet for other reasons (e.g., Celiac disease), - Currently taking any medication that is meant for weight loss, or has known effect on appetite suppression, - History of eating disorder(s). - History of surgical intervention for weight management (e) active eating disorder. - Chronic kidney disease with an eGFR calculated based on the Modification of Diet in Renal Disease (MDRD) equation <50mL/min/1.73m2 - 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) - Liver cirrhosis and/or significant alterations in liver function - 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. - 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. - 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). |
Country | Name | City | State |
---|---|---|---|
United States | Altman Clinical and Translational Research Institute | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | Salk Institute for Biological Studies |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety of 8-10 hour TRE in patients with type II diabetes mellitus on stable medication assessed by daily fasting glucose and ketone measurements (finger pricks). | Any hypoglycemic events reported from daily finger pricks will be reported | Baseline through 3 months | |
Other | Long term TRE adherence | Ability to self-sustain TRE assessed via logging on the mCC app 2 weeks/month. [Timeframe: 3-month to 6-month follow-up] | 3-month to 6-month follow-up | |
Primary | Glycemic regulation assessed by HbA1c | Change in blood glucose assessed via hemoglobin A1c. | Baseline and 3 months | |
Secondary | Glycemic regulation assessed by Continuous Glucose Monitor (CGM) | Change in glycemic regulation as assessed by CGM from interstitial glucose with outcomes including time in range, glycemic variability, and mean glucose. | Baseline and 3 months | |
Secondary | Fasting plasma glucose (mg/dL) | Change in glycemic regulation as assessed fasting plasma glucose (mg/dL). | Baseline and 3 months | |
Secondary | Fasting plasma insulin (mIU/L) | Change in glycemic regulation as assessed changes in fasting plasma insulin (mIU/L). | Baseline and 3 months | |
Secondary | HOMA-IR | Change in glycemic regulation as assessed by HOMA-IR. | Baseline and 3 months | |
Secondary | LDL Particle Number (nmol/L) | Changes in atherogenic lipids assessed via LDL Particle Number (nmol/L) via NMR Lipoproteinprofile. | Baseline and 3 months | |
Secondary | Non-HDL Cholesterol (mg/dL) | Changes in atherogenic lipids assessed via Non-HDL Cholesterol (mg/dL). | Baseline and 3 months | |
Secondary | Triglycerides (mg/dL) | Changes in atherogenic lipids assessed via Triglycerides (mg/dL). | Baseline and 3 months | |
Secondary | Apolipoprotein B (ApoB) | Changes in atherogenic lipids assessed via ApoB (mg/dL). | Baseline and 3 months | |
Secondary | Quality of life Assessment via Short Form-36 Questionnaire (SF-36) | Changes in quality of life as assessed by the SF-36 questionnaire. | Baseline and 3 months |
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