Microalbuminuria, Time Restricted Eating, Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
Microalbuminuria, Time Restricted Eating, Urine Albumin-to-Creatinine Ratio, Type 2 Diabetes, uACR, Fasting
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.
Detailed description
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.
Interventions
BEHAVIORALTime Restricted Eating
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.
Sponsors
University of California, San Diego
Salk Institute for Biological Studies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18-75 years old 2. Participants with T2DM with A1c between 6.5 and 9.0 % and on stable doses of medications who are weight-bearing and self-ambulatory. 3. uACR ( urine albumin creatinine ratio) results ≥ 30 - 300 mg. 4. Willingness to use smartphone for research procedures (Apple iOS or Android OS) 5. Baseline eating period ≥12 hours/day and sufficient logging on the mCC app. 6. Person of childbearing potential will be given a pregnancy test on study enrollment and asked to use contraception throughout the study. 7. Post-menopausal and individuals on hormone replacement therapy will be included. 8. Estimated Glomerular Filtration Rate (EGFR) \> 45 9. 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 10. Participants on stable doses (consistent dose for ≥3 months) of GLP-1 receptor agonists will be included.
Exclusion criteria
1. Participants with Type1DM and T2DM who are taking insulin, sulfonylureas, or have an HbA1c \> 9 %. 2. Estimated Glomerular Filtration Rate (EGFR) \< 45 3. Systolic BP greater than 160 mmHg and/or Diastolic BP greater than 110 mmHg (with or without treatment/medication) 4. LDL cholesterol greater than 200 mg/dL 5. Triglycerides greater than 500 mg/dL 6. Active tobacco or illicit drug use 7. Pregnant or breastfeeding individuals. 8. Currently enrolled in a weight-loss or weight-management program, 9. Currently on a special or prescribed diet for other reasons (e.g., Celiac disease), 10. 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 ). 11. History of eating disorder(s). 12. History of surgical intervention for weight management (e) active eating disorder. 13. Chronic kidney disease with an eGFR calculated based on the Modification of Diet in Renal Disease (MDRD) equation \<50mL/min/1.73m2 14. Treatment for active inflammatory and/or rheumatologic disease and cancer. 15. 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). 16. History of Uncontrolled arrhythmia (i.e., rate-controlled atrial fibrillation/atrial flutter are not
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine albumin-to-creatinine ratio (uACR) | Baseline and 3 months | Change in uACR (mg/g) assessed via urine sample |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic regulation assessed by Continuous Glucose Monitor (CGM) | Baseline and 3 months | Change in glycemic regulation as assessed by CGM from interstitial glucose with various outcomes measured. |
| Fasting glucose levels (mg/dL) | Baseline and 3 months | Change in glycemic regulation as assessed fasting plasma glucose (mg/dL). |
| LDL-Cholesterol | Baseline and 3 months | Changes in atherogenic lipids assessed via LDL-Cholesterol. |
| Glycemic regulation assessed by HbA1c | Baseline and 3 months | Change in blood glucose assessed via hemoglobin A1c. |
| Blood pressure | Baseline and 3 months | Change in blood pressure assessed by sphygmomanometer. |
| Non-HDL Cholesterol (nmol/mol) | Baseline and 3 months | Changes in atherogenic lipids assessed via LDL-Cholesterol. |
| Triglycerides (mg/dL) | Baseline and 3 months | Changes in atherogenic lipids assessed via Triglycerides (mg/dL). |
| Quality of life Assessment via Short Form-36 Questionnaire (SF-36) | Baseline and 3 months | 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. |
| Sleep Quality Assessment via Pittsburgh Sleep Quality Index (PSQI) | Baseline and 3 months | 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 |
| Microvascular health measured via skin capillary density by capillaroscopy | Baseline and 3 months | — |
| Microvascular health measured via % capillary recruitment by capillaroscopy | Baseline and 3 months | — |
| Microvascular health measured via heat-induced skin %-hyperemia by Laser Doppler | Baseline and 3 months | — |
Countries
United States
Contacts
CONTACTGavin C McLaren, BA
CONTACTMarissa Dzotsi, MPH
PRINCIPAL_INVESTIGATORPam Taub, MD
University of California, San Diego Health
Outcome results
None listed