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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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.
Altman Clinical and Translational Research Institute
La Jolla, California, United States
Urine albumin-to-creatinine ratio (uACR)
Change in uACR (mg/g) assessed via urine sample
Time frame: Baseline and 3 months
Glycemic regulation assessed by Continuous Glucose Monitor (CGM)
Change in glycemic regulation as assessed by CGM from interstitial glucose with various outcomes measured.
Time frame: Baseline and 3 months
Fasting glucose levels (mg/dL)
Change in glycemic regulation as assessed fasting plasma glucose (mg/dL).
Time frame: Baseline and 3 months
Glycemic regulation assessed by HbA1c
Change in blood glucose assessed via hemoglobin A1c.
Time frame: Baseline and 3 months
Blood pressure
Change in blood pressure assessed by sphygmomanometer.
Time frame: Baseline and 3 months
LDL-Cholesterol
Changes in atherogenic lipids assessed via LDL-Cholesterol.
Time frame: Baseline and 3 months
Non-HDL Cholesterol (nmol/mol)
Changes in atherogenic lipids assessed via LDL-Cholesterol.
Time frame: Baseline and 3 months
Triglycerides (mg/dL)
Changes in atherogenic lipids assessed via Triglycerides (mg/dL).
Time frame: Baseline and 3 months
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Quality of life Assessment via Short Form-36 Questionnaire (SF-36)
Changes in quality of life will be assessed using the SF-36 questionnaire, with scores ranging from 0 to 100, where higher scores indicate better health outcomes.
Time frame: Baseline and 3 months
Sleep Quality Assessment via Pittsburgh Sleep Quality Index (PSQI)
Changes in sleep quality will be assessed using the PSQI questionnaire, which evaluates sleep quality over the past month. The PSQI produces a global score ranging from 0 to 21, with higher scores indicating worse sleep quality
Time frame: Baseline and 3 months