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| Name | Class |
|---|---|
| University Hospital, Geneva | OTHER |
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Chronic kidney disease (CKD) affects approximately 12 to 15% of adults worldwide, with an increasing incidence expected. Major causes include diabetic nephropathy, hypertension, and various glomerulonephritis. Proteinuria is a key factor in identifying and assessing the risk of CKD progression.
The precise pathophysiology of CKD is not fully understood, but recent research highlights metabolic alterations, particularly in lipid and glucose metabolism. CKD progression is influenced by diet, as evidenced by recent studies. Interventions such as the ketogenic diet and time-restricted feeding show promising results in improving metabolism and may have beneficial effects on CKD.
Our study aims to evaluate the impact of time-restricted eating (TRE) on proteinuria, the decline in glomerular filtration rate, and weight loss in patients with moderate CKD with albuminuria (KDIGO stage 2-3). This will allow us to better understand the efficacy of this dietary approach tailored to the individual habits of participants.
The primary outcome measure will be albuminuria before and after the 12-week intervention. Secondary outcome measures will include the impact of fasting on blood pressure as assessed by 24-hour ambulatory monitoring, body composition evaluated by DXA and BIA, continuous glucose monitoring, and blood hormone profiles. Additionally, the feasibility and safety of TRE in this population will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time-restricted eating | Experimental |
| |
| Active control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time-restricted eating | Behavioral | Participants will be advised to consume meals and calorie-containing drinks only during a window of 8 hours, to be self-selected by the participant and advised by the investigators based on their daily routine and eating habits during the run-in phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in urine albumin/creatinine ratio (UACR) | Measured by 24h urine collection | From randomization to close-out visit (12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in creatinine- and cystatin-estimated glomerular filtration rate (eGFR) | Measured in clinical chemistry | From randomization to close-out visit (12 weeks) |
| Change in blood pressure | Measured by 24h ambulatory blood pressure monitoring (ABPM) |
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Inclusion Criteria:
Clinical criteria
Study-related criteria
Exclusion Criteria:
Clinical criteria
Study-related criteria and other interventions
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Delal Dalga, MD, PhD | Contact | +41-22-3723311 | delal.dalga@unige.ch | |
| Anna Faivre, MD, PhD | Contact | +41-79-5534361 | anna.faivre@hug.ch |
| Name | Affiliation | Role |
|---|---|---|
| Sophie de Seigneux, MD, PhD | University Hospital, Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Geneva | Recruiting | Geneva | 1211 | Switzerland |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
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| Active control | Behavioral | Participants will be advised to keep the same eating rhythm and timing of meals per day during the intervention. |
|
| From randomization to close-out visit (12 weeks) |
| Change in systolic and diastolic blood pressure | Measured with an arm cuff in the sitting position | From randomization to close-out visit (12 weeks) |
| Change in body fat mass and regional distribution | Measured by dual-energy X-ray absorptiometry (DXA) | From randomization to close-out visit (12 weeks) |
| Change in body fat mass | Measured by bioelectrical impedance (BIA) | From randomization to close-out visit (12 weeks) |
| Change in fasting glucose | Measured in clinical chemistry | From randomization to close-out visit (12 weeks) |
| Change in glucose excursion | Measured by continuous glucose monitoring (CGM) | From randomization to close-out visit (12 weeks) |
| Change in physical activity | Measured by actigraphy | From randomization to close-out visit (12 weeks) |
| Change in sleep/wake cycles | Measured by actigraphy | From randomization to close-out visit (12 weeks) |
| Change in sleep quality | Measured by the Pittsburgh Sleep Quality Index (PSQI, range 0-21) | From randomization to close-out visit (12 weeks) |
| Change in eating duration | Duration from the first to last caloric intake over the 24h cycle | From randomization to close-out visit (12 weeks) |
| Change in weight | Body weight (kg) | From randomization to close-out visit (12 weeks) |
| Change in lipid profile (concentration of total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) | Measured in clinical chemistry | From randomization to close-out visit (12 weeks) |
| Change in blood hormone profile | Measured in clinical chemistry | From randomization to close-out visit (12 weeks) |
| Incidence of adverse events in response to the randomized intervention | Adverse events graded after the Common Terminology Criteria for Adverse Events version 5.0 | From randomization to close-out visit (12 weeks) |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |