Time Restricted Eating in Patients With Microalbuminuria
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of California, San Diego
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Time Restricted Eating
BehavioralParticipants 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Time Restricted Eating (TRE) GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Urine albumin-to-creatinine ratio (uACR)
Change in uACR (mg/g) assessed via urine sample
Time frame
Baseline and 3 monthsSecondary outcomes
1
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 months2
Fasting glucose levels (mg/dL)
Change in glycemic regulation as assessed fasting plasma glucose (mg/dL).
Time frame
Baseline and 3 months3
LDL-Cholesterol
Changes in atherogenic lipids assessed via LDL-Cholesterol.
Time frame
Baseline and 3 months4
Glycemic regulation assessed by HbA1c
Change in blood glucose assessed via hemoglobin A1c.
Time frame
Baseline and 3 monthsOther outcomes
1
Anti-inflammatory effects of TRE
Hypothesis-generating exploration and measure of anti-inflammatory effects of TRE assessed by plasma inflammatory cytokine levels.
Time frame
Baseline and 3 months2
Time in Range
Change in the time spent within the target glucose range, as assessed by Continuous Glucose Monitoring (CGM) from interstitial glucose.
Time frame
Baseline and 3 months3
Glycemic Variability
Change in glycemic variability, as assessed by Continuous Glucose Monitoring (CGM) from interstitial glucose.
Time frame
Baseline and 3 months4
Mean Glucose
Change in mean glucose levels, as assessed by Continuous Glucose Monitoring (CGM) from interstitial glucose.
Time frame
Baseline and 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Diego
Lead sponsor
Salk Institute for Biological Studies
Collaborator
Source ClinicalTrials.gov