NCT06884059Toboroz1. fázis
Time Restricted Eating in Patients With Microalbuminuria
Impact of Time-Restricted Eating (TRE) on Kidney Health (The TREK Study)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 14.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 25 (tervezett)
- Első benyújtás
- 2025. márc. 5.
- Kezdés
- 2026. júl.
- Elsődleges befejezés
- 2027. febr.
- Fő szponzor
- University of California, San Diego
- Betegségek
- 2-es típusú cukorbetegség
- NCT-szám
- NCT06884059
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1. fázis
- Tervezett résztvevők: 25
- 2026. júl. és az elsődleges befejezés (2027. febr.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Systolic BP greater than 160 mmHg and/or Diastolic BP greater than 110 mmHg (with or without treatment/medication)
- Active tobacco or illicit drug use
- 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 ).
Más betegség
- History of eating disorder(s).
- History of surgical intervention for weight management (e) active eating disorder.
- 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).
- History of Uncontrolled arrhythmia (i.e., rate-controlled atrial fibrillation/atrial flutter are not exclusion criteria) 18. Liver cirrhosis and/or significant alterations in liver function
- History of (a) thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e., hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion), Shift workers with variable (e.g., nocturnal) hours.
- History of major adverse cardiovascular events within the past 1 year (acute coronary syndrome (ACS), percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack (TIA)).
- History of thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e., hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion).
- History of adrenal disease.
- History of malignancy undergoing active treatment, except non-melanoma skin cancer.
- Known history of type I diabetes.
- History of stage 4 or 5 chronic kidney disease or requiring dialysis.
- History of HIV/AIDS.
- Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
Laborértékek
- Participants with Type1DM and T2DM who are taking insulin, sulfonylureas, or have an HbA1c > 9 %.
- Estimated Glomerular Filtration Rate (EGFR) < 45
- LDL cholesterol greater than 200 mg/dL
- Triglycerides greater than 500 mg/dL
- Chronic kidney disease with an eGFR calculated based on the Modification of Diet in Renal Disease (MDRD) equation <50mL/min/1.73m2
Egyéb
- Pregnant or breastfeeding individuals.
- Currently enrolled in a weight-loss or weight-management program,
- Caregivers for dependents requiring frequent nocturnal care/sleep interruptions.
- More than one trip planned to travel to a time zone with greater than a 3-hour difference during study period.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Altman Clinical and Translational Research Institute | La Jolla | Egyesült Államok | Toboroz |
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