Sweet & Sour: Dietary Acid Load in Type 2 Diabetes and Kidney Disease Across Sex and Ethnic Groups

ConditionsType 2 Diabetes Chronic Kidney Disease

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorErasmus Medical Center

About this trial

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:

* be randomly assigned to follow either a high- or low-acid load diet for 8 weeks; * Visit the study center four times (including screening) * Complete food diaries three times per week and keep in regular contact with a dietitian; * Collect 2x24-hour urine samples and morning feces at each visit ; * Undergo blood sampling and an oral glucose tolerance test (OGTT). * Spend a total of 8 hours at the study center (2 visits of 3 hours for OGTT and body composition tests, and 2 visits of 1 hour for additional assessments); * Have up to 200 ml of blood collected during the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 years

Presence of T2D and CKD stage G1-3a with albuminuria (>10mg/mmol)

BMI≥ 25kg/m2 - Use of metformin on a stable dose (i.e. no changes in the last three months)

Adequate knowledge of the Dutch language to comprehend the provided study information

Disqualifiers

Use of insulin

serum bicarbonate < 20 mmol/L

Use of antibiotics 3 months before inclusion

Vegetarian diet - Presence of inflammatory bowel disease or other chronic inflammatory disease

Trial design

Design model

Parallel

Treatments tested in this trial

Low Dietary Acid Load
Other intervention
This arm will follow a DAL lowering diet with the aim to reach \<25mEq H⁺/day

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: High Dietary Acid LoadNo intervention 0 interventions

Group B: Low Dietary Acid LoadExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Percentage change in urinary albumin-to-creatinine ratio (UACR)

Log-transformed urinary albumin-to-creatinine ratio (UACR), following an 8-week dietary intervention.

Time frame