Time Restricted Eating in Patients With Microalbuminuria

NCT06884059 | Not Yet Recruiting Phase 1

• 1 other identifier: 810456
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Time Restricted Eating; Microalbuminuria

Keywords

Microalbuminuria; Time Restricted Eating; Urine Albumin-to-Creatinine Ratio; Type 2 Diabetes; uACR; Fasting

Outcome Measures

Primary Outcomes (1)

• Urine albumin-to-creatinine ratio (uACR)

  Change in uACR (mg/g) assessed via urine sample

  Baseline and 3 months

Secondary Outcomes (9)

• 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

Other Outcomes (4)

• Anti-inflammatory effects of TRE

  Baseline and 3 months

• Time in Range

  Baseline and 3 months

• Glycemic Variability

  Baseline and 3 months

Study Arms (1)

Time Restricted Eating (TRE) Group

EXPERIMENTAL

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.

Behavioral: Time Restricted Eating

Interventions

Time Restricted Eating BEHAVIORAL

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.

Time Restricted Eating (TRE) Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, San Diego: lead
• Salk Institute for Biological Studies: collaborator

Study Sites (1)

Altman Clinical and Translational Research Institute

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Intermittent Fasting; Fasting

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Feeding Behavior; Behavior

Study Officials

• Pam Taub, MD

  University of California, San Diego Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gavin C McLaren, BA

CONTACT

(858) 246-2342; preventivecvresearch@health.ucsd.edu

Marissa Dzotsi, BS, MPH

CONTACT

(858) 246-2715; preventivecvresearch@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pam Taub, MD, Professor of Medicine

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 19, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 19, 2025

Record last verified: 2025-01

Locations

US (1)