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| Name | Class |
|---|---|
| Salk Institute for Biological Studies | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Urine albumin-to-creatinine ratio (uACR) | Change in uACR (mg/g) assessed via urine sample | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic regulation assessed by Continuous Glucose Monitor (CGM) | Change in glycemic regulation as assessed by CGM from interstitial glucose with various outcomes measured. | Baseline and 3 months |
| Fasting glucose levels (mg/dL) |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-inflammatory effects of TRE | Hypothesis-generating exploration and measure of anti-inflammatory effects of TRE assessed by plasma inflammatory cytokine levels. | Baseline and 3 months |
| Time in Range |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gavin C McLaren, BA | Contact | (858) 246-2342 | preventivecvresearch@health.ucsd.edu | |
| Marissa Dzotsi, BS, MPH | Contact | (858) 246-2715 | preventivecvresearch@health.ucsd.edu |
| Name | Affiliation | Role |
|---|---|---|
| Pam Taub, MD | University of California, San Diego Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altman Clinical and Translational Research Institute | La Jolla | California | 92093 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D000093763 | Intermittent Fasting |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Change in glycemic regulation as assessed fasting plasma glucose (mg/dL).
| Baseline and 3 months |
| Glycemic regulation assessed by HbA1c | Change in blood glucose assessed via hemoglobin A1c. | Baseline and 3 months |
| Blood pressure | Change in blood pressure assessed by sphygmomanometer. | Baseline and 3 months |
| LDL-Cholesterol | Changes in atherogenic lipids assessed via LDL-Cholesterol. | Baseline and 3 months |
| Non-HDL Cholesterol (nmol/mol) | Changes in atherogenic lipids assessed via LDL-Cholesterol. | Baseline and 3 months |
| Triglycerides (mg/dL) | Changes in atherogenic lipids assessed via Triglycerides (mg/dL). | Baseline and 3 months |
| 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. | 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 | Baseline and 3 months |
Change in the time spent within the target glucose range, as assessed by Continuous Glucose Monitoring (CGM) from interstitial glucose.
| Baseline and 3 months |
| Glycemic Variability | Change in glycemic variability, as assessed by Continuous Glucose Monitoring (CGM) from interstitial glucose. | Baseline and 3 months |
| Mean Glucose | Change in mean glucose levels, as assessed by Continuous Glucose Monitoring (CGM) from interstitial glucose. | Baseline and 3 months |
| D004700 | Endocrine System Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |