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Chronic kidney disease (CKD) is a common condition and a major global cause of illness and mortality. The most common cause of kidney damage is diabetes, a condition that disrupts metabolism, leading to increased risk of damage to the kidneys and blood vessels. There is evidence suggesting that a diet with high acid load - consisting of acid-forming foods such as meat, cheese, and grain products - may contribute to this damage. People with such a diet often have poorer blood sugar control and more kidney damage. However, it is not yet well understood whether reducing dietary acid load can improve kidney function and diabetes management. Additionally, the role of ethnicity and sex in this process remains insufficiently explored.
The goal of this clinical trial is to understand how diet affects kidney function and blood sugar regulation in individuals with diabetes type 2 and chronic kidney disease, as well as to explore the role of sex and ethnicity in these effects. The main questions it aims to answer are:
Does a diet with lower acid load (e.g. less meat, cheese, and grain products) improve kidney function and blood sugar regulation in people with diabetes type 2 and chronic kidney disease?
Does the effect of diet on kidney function and blood sugar differ between ethnic groups, specifically between White-Dutch and South-Asian Surinamese descent people?
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dietary Acid Load | No Intervention | This arm will follow their usual diet, which is between DAL> 50 or <120mEq H⁺/day (current western diets are generally all high DAL) | |
| Low Dietary Acid Load | Experimental | This arm will follow a DAL lowering diet with the aim to reach <25mEq H⁺/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Dietary Acid Load | Other | This arm will follow a DAL lowering diet with the aim to reach <25mEq H⁺/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in urinary albumin-to-creatinine ratio (UACR) | Log-transformed urinary albumin-to-creatinine ratio (UACR), following an 8-week dietary intervention. | Change between baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in estimated glomerular filtration rate (eGFR) | eGFR calculated using serum creatinine and/or cystatin C | Change between baseline and 8 weeks |
| Change in serum bicarbonate | Serum bicarbonate concentration measured in blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilias Attaye, Dr. | Contact | +31 10 704 0704 | i.attaye@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Ilias Attaye, Dr. | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Rotterdam | Netherlands |
Publication will be open access. All data is available upon resonable request from the Principal Investigator. Of note: All data will be pseudoanonymzed.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Single-centre, non-blinded, randomized controlled 8-week isocaloric dietary intervention trial
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| Change between baseline and 8 weeks |
| Change in urinary citrate | Urinary citrate excretion measured in 24-hour urine collections | Change between baseline and 8 weeks |
| Glucose response during Oral Glucose Tolerance Test | Area under the curve (AUC) of plasma glucose during oral glucose tolerance test (OGTT) | Change between baseline and 8 weeks |
| Change in glucose variability (MAGE) | Mean amplitude of glycemic excursions (MAGE) derived from continuous glucose monitoring (CGM) data. | Change between baseline and 8 weeks |
| Change in gut microbiota composition | Gut microbiota composition assessed in morning fecal samples collected using stool collection kits analyzed by 16S rRNA gene sequencing. | Change between baseline and 8 weeks |
| Change in serum metabolite profiles | Serum metabolite profiles measured using untargeted metabolomics analysis. | Change between baseline and 8 weeks |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |