Intermittent Fasting for Microalbuminuria

(TREK Trial)

Overseen By Gavin C McLaren, BA

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, San Diego

Must be taking: GLP-1 receptor agonists

Must not be taking: Insulin, Sulfonylureas

Disqualifiers: Type 1 diabetes, Insulin use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how time-restricted eating (TRE), where participants eat only within an 8-10 hour window each day, might improve kidney health in people with type 2 diabetes who have increased protein in their urine. The study aims to determine if this eating pattern can enhance kidney filtration. Participants will track their food intake using an app and wear a glucose monitor at specific times during the trial. People with type 2 diabetes, who are not on insulin and have stable medication doses, might be suitable candidates. Participants should also be comfortable using a smartphone for tracking their eating habits. As a Phase 1 trial, the research focuses on understanding how this eating pattern works in people, offering participants a chance to be among the first to explore its potential benefits.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. However, if you are on cardiovascular medications or GLP-1 receptor agonists, you must be on stable doses without any changes during the study.

What prior data suggests that time-restricted eating is safe for improving kidney health in type 2 diabetes patients?

Research suggests that intermittent fasting, such as time-restricted eating (TRE), might protect the kidneys, particularly in conditions like diabetic kidney disease. Animal studies have shown that TRE can improve kidney health by lowering blood pressure and reducing certain immune cells in the kidneys. This indicates that TRE could be safe and beneficial for kidney function.

Although animal study results are promising, human research remains in the early stages. This trial focuses on safety and how well participants can handle TRE. So far, similar studies have not reported any serious side effects. Participants typically eat within an 8-10 hour window each day. For those considering participation, it's important to note that early trials primarily test for safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for microalbuminuria that often involve medications like ACE inhibitors or ARBs to control blood pressure and reduce protein in the urine, Time Restricted Eating (TRE) offers a unique lifestyle approach. TRE involves limiting the hours in which participants eat each day to an 8-10 hour window, which can help regulate blood sugar levels naturally. This method is exciting for researchers because it promotes metabolic health without relying on medication, and it incorporates continuous glucose monitoring for precise tracking of its effects on glucose levels. This could potentially provide a more holistic and sustainable way to manage microalbuminuria.

What evidence suggests that time-restricted eating might be an effective treatment for microalbuminuria?

Studies have shown that time-restricted eating (TRE), which participants in this trial will follow, can benefit kidney health. In mice, TRE improved kidney function and slowed the progression of kidney disease. It also reduced immune cell activity in the kidneys and lowered blood pressure in cases of hypertension. Research suggests that intermittent fasting, like TRE, might protect against kidney damage in people with conditions such as diabetic nephropathy, a kidney problem related to diabetes. Although most evidence comes from animal studies, these findings are promising for people with type 2 diabetes and high levels of protein in their urine. ^{1 2 3 4 6}

Who Is on the Research Team?

Pam Taub, MD

Principal Investigator

University of California, San Diego Health

Are You a Good Fit for This Trial?

This trial is for individuals with type 2 diabetes who also have microalbuminuria, which means there's a bit more protein in their urine than normal. Participants should be willing to eat within an 8-10 hour window every day.

Inclusion Criteria

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

Exclusion Criteria

Shift workers with variable (e.g., nocturnal) hours

Estimated Glomerular Filtration Rate (EGFR) < 45

LDL cholesterol greater than 200 mg/dL

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a time-restricted eating (TRE) regimen with an 8-10 hour eating window and use a smartphone app to log food entries. They also wear a continuous glucose monitor (CGM) for the first and last two weeks of the trial.

12 weeks

Initial visit for setup, weekly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of glycemic variability, blood pressure, cholesterol, and quality of life.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Time Restricted Eating

Trial Overview The study is testing whether time-restricted eating (TRE), where participants only eat during a set period of the day, can improve kidney function and reduce protein levels in urine for those with type 2 diabetes.

How Is the Trial Designed?

Group I: Time Restricted Eating (TRE) Group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Salk Institute for Biological Studies

Collaborator

Trials

23

Recruited

2,200+

Citations

1. ejim.springeropen.com ejim.springeropen.com/articles/10.1186/s43162-025-00496-9

Impact of time-restricted feeding on renal function in advanced ... For instance, a study on mice found that TRF improved kidney function and slowed the progression of the disease [5, 6]. Other studies have shown ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9444961/

Time restricted feeding decreases renal innate immune ... Our findings demonstrate that TRF can significantly decrease renal innate immune cells and blood pressure in two mouse models of hypertension.

3. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT06884059

Time Restricted Eating in Patients With Microalbuminuria 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 ...

4. withpower.com withpower.com/trial/phase-1-time-restricted-eating-2-2025-9f0a2

Intermittent Fasting for Microalbuminuria · Info for Participants Research suggests that intermittent fasting, a form of time-restricted eating, may help protect against kidney damage in conditions like diabetic nephropathy ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2589537024000981

Intermittent fasting and health outcomes: an umbrella ... Our findings suggest that IF may have beneficial effects on a range of health outcomes for adults with overweight or obesity, compared to CER or non- ...

6. academic.oup.com academic.oup.com/ckj/advance-article/doi/10.1093/ckj/sfaf069/8051351

Time Restricted Eating and Autosomal Dominant Polycystic ... The eating window was 9.6±3.6 hours for TRE (60% achieving the 8-hour window) and 12.0±2.0 for HE groups (p=0.07). At month 12, both groups lost ...