Time Restricted Eating in Patients With Microalbuminuria

Official title

Impact of Time-Restricted Eating (TRE) on Kidney Health (The TREK Study)

Overview

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.

Detailed description

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.

Interventions

• Behavioral Time 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.

Primary outcome measures

• Urine albumin-to-creatinine ratio (uACR) [Time frame: Baseline and 3 months]

Secondary outcome measures (12)

• Glycemic regulation assessed by Continuous Glucose Monitor (CGM) [Time frame: Baseline and 3 months]
• Fasting glucose levels (mg/dL) [Time frame: Baseline and 3 months]
• LDL-Cholesterol [Time frame: Baseline and 3 months]
• Glycemic regulation assessed by HbA1c [Time frame: Baseline and 3 months]
• Blood pressure [Time frame: Baseline and 3 months]
• Non-HDL Cholesterol (nmol/mol) [Time frame: Baseline and 3 months]
• Triglycerides (mg/dL) [Time frame: Baseline and 3 months]
• Quality of life Assessment via Short Form-36 Questionnaire (SF-36) [Time frame: Baseline and 3 months]
• Sleep Quality Assessment via Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline and 3 months]
• Microvascular health measured via skin capillary density by capillaroscopy [Time frame: Baseline and 3 months]
• Microvascular health measured via % capillary recruitment by capillaroscopy [Time frame: Baseline and 3 months]
• Microvascular health measured via heat-induced skin %-hyperemia by Laser Doppler [Time frame: Baseline and 3 months]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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) 18. 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Altman Clinical and Translational Research Institute — La Jolla

Identifiers

NCT: NCT06884059 · 810456

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗