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

25 Participants Needed

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the treatment Time Restricted Eating for Microalbuminuria?

Research suggests that intermittent fasting, a form of time-restricted eating, may help protect against kidney damage in conditions like diabetic nephropathy by improving metabolic health. Additionally, weight loss through dietary changes, which can include time-restricted eating, has been shown to reduce proteinuria (excess protein in urine), a condition related to microalbuminuria. ^{1 2 3 4 5}

How does Time Restricted Eating differ from other treatments for microalbuminuria?

Time Restricted Eating, a form of intermittent fasting, is unique because it focuses on limiting the hours of food intake rather than the type or amount of food, which may help improve metabolic health and reduce risk factors associated with microalbuminuria, such as high blood pressure and poor glycemic control, without the need for medication. ^{6 7 8 9 10}

Research Team

Pam Taub, MD

Principal Investigator

University of California, San Diego Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Intermittent Fasting-A Healthy Dietary Pattern for Diabetic Nephropathy. [2022]

2. Japan pubmed.ncbi.nlm.nih.gov

The suppressive effects of dietary protein restriction on the progression of renal impairment in OLETF rats. [2018]

3. Australia pubmed.ncbi.nlm.nih.gov

Cyclic and intermittent very low-protein diet can have beneficial effects against advanced diabetic nephropathy in Wistar fatty (fa/fa) rats, an animal model of type 2 diabetes and obesity. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The effect of weight loss in obesity and chronic kidney disease. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Do obesity and non-insulin dependent diabetes mellitus aggravate exercise-induced microproteinuria? [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Microalbuminuria is positively associated with usual dietary saturated fat intake and negatively associated with usual dietary protein intake in people with insulin-dependent diabetes mellitus. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Microalbuminuria in single kidney patients: relationship with protein intake. [2004]

8. United States pubmed.ncbi.nlm.nih.gov

Microalbuminuria: what is it? Why is it important? What should be done about it? [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Prognostic significance of microalbuminuria. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

How to protect the kidney in diabetic patients: with special reference to IDDM. [2019]