Sweet & Sour: Dietary Acid Load in Type 2 Diabetes and Kidney Disease Across Sex and Ethnic Groups (Sweet & Sour)
Sweet & Sour: Exploring Dietary Acid Load in Type 2 Diabetes & Kidney Disease Across Sex and Ethnicity
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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Ilias Attaye, Dr.
- 電話番号:+31 10 704 0704
- メール:i.attaye@erasmusmc.nl
研究場所
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Rotterdam、オランダ
- Erasmus Medical Center
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コンタクト:
- Ilias Attaye, Dr.
- 電話番号:+31 10 704 0704
- メール:i.attaye@erasmusmc.nl
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主任研究者:
- Ilias Attaye, Dr.
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副調査官:
- Dagmar Dekker, MSc
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし: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)
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実験的:Low Dietary Acid Load
This arm will follow a DAL lowering diet with the aim to reach <25mEq H⁺/day
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This arm will follow a DAL lowering diet with the aim to reach <25mEq H⁺/day
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage change in urinary albumin-to-creatinine ratio (UACR)
時間枠:Change between baseline and 8 weeks
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Log-transformed urinary albumin-to-creatinine ratio (UACR), following an 8-week dietary intervention.
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Change between baseline and 8 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in estimated glomerular filtration rate (eGFR)
時間枠:Change between baseline and 8 weeks
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eGFR calculated using serum creatinine and/or cystatin C
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Change between baseline and 8 weeks
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Change in serum bicarbonate
時間枠:Change between baseline and 8 weeks
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Serum bicarbonate concentration measured in blood
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Change between baseline and 8 weeks
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Change in urinary citrate
時間枠:Change between baseline and 8 weeks
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Urinary citrate excretion measured in 24-hour urine collections
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Change between baseline and 8 weeks
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Glucose response during Oral Glucose Tolerance Test
時間枠:Change between baseline and 8 weeks
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Area under the curve (AUC) of plasma glucose during oral glucose tolerance test (OGTT)
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Change between baseline and 8 weeks
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Change in glucose variability (MAGE)
時間枠:Change between baseline and 8 weeks
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Mean amplitude of glycemic excursions (MAGE) derived from continuous glucose monitoring (CGM) data.
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Change between baseline and 8 weeks
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Change in gut microbiota composition
時間枠:Change between baseline and 8 weeks
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Gut microbiota composition assessed in morning fecal samples collected using stool collection kits analyzed by 16S rRNA gene sequencing.
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Change between baseline and 8 weeks
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Change in serum metabolite profiles
時間枠:Change between baseline and 8 weeks
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Serum metabolite profiles measured using untargeted metabolomics analysis.
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Change between baseline and 8 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Ilias Attaye, Dr.、Erasmus Medical Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NL-010928
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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