Sweet & Sour: Exploring Dietary Acid Load in Type 2 Diabetes & Kidney Disease Across Sex and Ethnicity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percentage change in urinary albumin-to-creatinine ratio (UACR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •If incretin therapy is used, then subject must have used that for a minimum of 6 months before starting with the trial
- •Use of ACE inhibitors or angiotensin II receptor blokkers
- •Of white European Dutch or South-Asian Surinamese descent
排除标准
- •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
- •Alcohol consumption of more than 14 units per week in women, or more than 21 units per week in men
- •Active malignancy - bariatric or other weight loss surgery in the history
- •patients diagnosed with eating disorders (such as bulimia nervosa, anorexia nervosa or binge-eating disorder)
- •HbA1c >9% (75mmol/mol) at screening
- •Unmotivated or not able to adhere to a specific diet
- •The subject is already currently involved in a clinical trial
研究组 & 干预措施
High Dietary Acid Load
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
This arm will follow a DAL lowering diet with the aim to reach <25mEq H⁺/day
干预措施: Low Dietary Acid Load (Other)
结局指标
主要结局
Percentage change in urinary albumin-to-creatinine ratio (UACR)
时间窗: Change between baseline and 8 weeks
Log-transformed urinary albumin-to-creatinine ratio (UACR), following an 8-week dietary intervention.
次要结局
- Change in serum metabolite profiles(Change between baseline and 8 weeks)
- Change in estimated glomerular filtration rate (eGFR)(Change between baseline and 8 weeks)
- Change in serum bicarbonate(Change between baseline and 8 weeks)
- Change in urinary citrate(Change between baseline and 8 weeks)
- Glucose response during Oral Glucose Tolerance Test(Change between baseline and 8 weeks)
- Change in glucose variability (MAGE)(Change between baseline and 8 weeks)
- Change in gut microbiota composition(Change between baseline and 8 weeks)
研究者
Ilias Attaye, MD, PhD
Principal Investigator
Erasmus Medical Center