Diabetes Mellitus, Type 2, Diabetes type2, Time Restricted Feeding
Conditions
Brief summary
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).
Detailed description
The intervention will last for 12 weeks with a follow-up assessment at 6 months. This study will deliver the intervention, monitor participant health for safety, and promote compliance through clinic visits, virtual consultations, and an innovative combination of sensors, including continuous glucose monitors, actiwatches (to assess activity and sleep patterns), and the myCircadianClock smartphone app (to capture food, beverage, and medicine intake in real time). In-depth clinical and analytical measurements will be conducted at baseline and at the end of the intervention. We hypothesize that TRE will result in improved glucose levels (assessed via Hemoglobin A1c, the gold standard in clinical trials of T2D) and improved cardiovascular health (assessed via LDL or "bad" Cholesterol and Triglycerides). We will also be examining long-term adherence to TRE and improvements in quality of life. The proposed study will be the first adequately powered, randomized trial of TRE in patients with T2DM on background medical therapy. It is founded on a strong scientific premise and utilizes rigorous study design, state-of-the-art methods for analyzing outcomes, and an innovative approach for engaging and sustaining participation. Successful completion of this clinical trial will lay the scientific foundation and establish safety parameters for widespread implementation of TRE in patients with T2DM.
Interventions
BEHAVIORALTime-Restricted Eating
Participants in the TRE group with continue to follow their physicians treatment plan for type II diabetes mellitus and consume all of their food within an 8-10 hour eating window.
BEHAVIORALStandard of Care
Participants in the Standard of Care group will continue to follow their physician's treatment plan for type II diabetes mellitus.
Sponsors
University of California, San Diego
Salk Institute for Biological Studies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18-75 years old 2. Patients with T2DM with A1c between 6.5 and 9.0 % and on stable doses of medications who are weight-bearing and self-ambulatory. 3. Own a smartphone (Apple iOS or Android OS) 4. Baseline eating period ≥12 hours/day and sufficient logging on the mCC app. 5. Women of childbearing age will be given a pregnancy test on study enrollment and asked to use contraception throughout the study. 6. Post-menopausal and women on hormone replacement therapy will be included. 7. Estimated Glomerular Filtration Rate (EGFR) \> 30mL/min/1.73m2 8. 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 9. Patients on stable doses of GLP-1 receptor agonists will be included.
Exclusion criteria
10. Participants with Type1DM and T2DM who are taking insulin, sulfonylureas, or have an HbA1c \> 9 %. 11. BMI \> 50 kg/m2 12. Systolic BP greater than 160 mmHg and/or Diastolic BP greater than 110 mmHg (with or without treatment/medication) 13. LDL cholesterol greater than 200 mg/dL 14. Triglycerides greater than 500 mg/dL 15. Active tobacco or illicit drug use 16. Pregnant or breastfeeding women. 17. Currently enrolled in a weight-loss or weight-management program, 18. Currently on a special or prescribed diet for other reasons (e.g., Celiac disease), 19. 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. 20. History of eating disorder(s). 21. History of surgical intervention for weight management (e) active eating disorder. 22. Chronic kidney disease with an eGFR calculated based on the Modification of Diet in Renal Disease (MDRD) equation \< 30mL/min/1.73m2 23. Treatment for active inflammatory and/or rheumatologic disease and cancer. 24. 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). 25. History of Uncontrolled arrhythmia (i.e., rate-controlled atrial fibrillation/atrial flutter are not
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic regulation assessed by HbA1c | Baseline and 3 months | Change in blood glucose assessed via hemoglobin A1c. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic regulation assessed by Continuous Glucose Monitor (CGM) | Baseline and 3 months | Change in glycemic regulation as assessed by CGM from interstitial glucose with outcomes including time in range, glycemic variability, and mean glucose. |
| Fasting plasma glucose (mg/dL) | Baseline and 3 months | Change in glycemic regulation as assessed fasting plasma glucose (mg/dL). |
| Fasting plasma insulin (mIU/L) | Baseline and 3 months | Change in glycemic regulation as assessed changes in fasting plasma insulin (mIU/L). |
| HOMA-IR | Baseline and 3 months | Change in glycemic regulation as assessed by HOMA-IR. |
| LDL Particle Number (nmol/L) | Baseline and 3 months | Changes in atherogenic lipids assessed via LDL Particle Number (nmol/L) via NMR Lipoproteinprofile. |
| Non-HDL Cholesterol (mg/dL) | Baseline and 3 months | Changes in atherogenic lipids assessed via Non-HDL Cholesterol (mg/dL). |
| Triglycerides (mg/dL) | Baseline and 3 months | Changes in atherogenic lipids assessed via Triglycerides (mg/dL). |
| Apolipoprotein B (ApoB) | Baseline and 3 months | Changes in atherogenic lipids assessed via ApoB (mg/dL). |
| Quality of life Assessment via Short Form-36 Questionnaire (SF-36) | Baseline and 3 months | Changes in quality of life as assessed by the SF-36 questionnaire. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPam Taub, MD
Professor of Medicine
Outcome results
None listed