Impact of Time-Restricted Eating (TRE) on Kidney Health (The TREK Study)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Urine albumin-to-creatinine ratio (uACR)
研究概览
简要总结
This is a clinical trial to assess how time-restricted eating (TRE) may improve kidney health and filtration patients with type 2 diabetes and increased protein content in their urine. All participants will be participating in TRE in which they follow a consistent 8-10 hour eating window everyday.
详细描述
The proposed study aims to address the unmet medical need of treating microalbuminuria, particularly in patients with diabetes, through a prospective single-arm intervention lasting twelve weeks. Microalbuminuria, indicative of abnormal glomerular capillary permeability, serves as an early marker for renal impairment and heightened cardiovascular risk. The study hypothesizes that adherence to time-restricted eating (TRE) over the intervention period will significantly reduce microalbuminuria levels, as assessed by the urine albumin-to-creatinine ratio (uACR). Unlike other methods, uACR provides an estimation of 24-hour urine albumin excretion and is unaffected by variations in urine concentration, eliminating the need for timed specimens or 24-hour collections. If successful, this study could highlight the potential of TRE as a non-invasive and accessible dietary intervention for managing microalbuminuria and related conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 years old
- •Participants with T2DM with A1c between 6.5 and 9.0 % and on stable doses of medications who are weight-bearing and self-ambulatory.
- •uACR ( urine albumin creatinine ratio) results ≥ 30 - 300 mg.
- •Willingness to use smartphone for research procedures (Apple iOS or Android OS)
- •Baseline eating period ≥12 hours/day and sufficient logging on the mCC app.
- •Person of childbearing potential will be given a pregnancy test on study enrollment and asked to use contraception throughout the study.
- •Post-menopausal and individuals on hormone replacement therapy will be included.
- •Estimated Glomerular Filtration Rate (EGFR) > 45
- •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
- •Participants on stable doses (consistent dose for ≥3 months) of GLP-1 receptor agonists will be included.
排除标准
- •Participants with Type1DM and T2DM who are taking insulin, sulfonylureas, or have an HbA1c > 9 %.
- •Estimated Glomerular Filtration Rate (EGFR) < 45
- •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 individuals.
- •Currently enrolled in a weight-loss or weight-management program,
- •Currently on a special or prescribed diet for other reasons (e.g., Celiac disease),
- •On recently prescribed medication that is meant for weight loss, or has known effect on appetite suppression ( patient on stable dose for 3 months can be enrolled ).
- •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), 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).
研究组 & 干预措施
Time Restricted Eating (TRE) Group
Participants will limit the number of hours they eat in a dat to an 8-10 window and will also receive the standard heath and nutritional wellness guidelines. They will also be required to log food entries through the use of a smartphone app. Patients will also be required to wear a continuous glucose monitor (CGM) for the first and last two weeks of the 14 trial.
干预措施: Time Restricted Eating (Behavioral)
结局指标
主要结局
Urine albumin-to-creatinine ratio (uACR)
时间窗: Baseline and 3 months
Change in uACR (mg/g) assessed via urine sample
次要结局
- Glycemic regulation assessed by Continuous Glucose Monitor (CGM)(Baseline and 3 months)
- Fasting glucose levels (mg/dL)(Baseline and 3 months)
- Glycemic regulation assessed by HbA1c(Baseline and 3 months)
- Blood pressure(Baseline and 3 months)
- LDL-Cholesterol(Baseline and 3 months)
- Non-HDL Cholesterol (nmol/mol)(Baseline and 3 months)
- Triglycerides (mg/dL)(Baseline and 3 months)
- Quality of life Assessment via Short Form-36 Questionnaire (SF-36)(Baseline and 3 months)
- Sleep Quality Assessment via Pittsburgh Sleep Quality Index (PSQI)(Baseline and 3 months)
- Microvascular health measured via skin capillary density by capillaroscopy(Baseline and 3 months)
- Microvascular health measured via % capillary recruitment by capillaroscopy(Baseline and 3 months)
- Microvascular health measured via heat-induced skin %-hyperemia by Laser Doppler(Baseline and 3 months)
研究者
Pam Taub, MD
Pam Taub, MD, Professor of Medicine
University of California, San Diego