- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07587918
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ilias Attaye, Dr.
- 전화번호: +31 10 704 0704
- 이메일: i.attaye@erasmusmc.nl
연구 장소
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Rotterdam, 네덜란드
- Erasmus Medical Center
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연락하다:
- Ilias Attaye, Dr.
- 전화번호: +31 10 704 0704
- 이메일: i.attaye@erasmusmc.nl
-
수석 연구원:
- Ilias Attaye, Dr.
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부수사관:
- Dagmar Dekker, MSc
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: 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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실험적: 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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage change in urinary albumin-to-creatinine ratio (UACR)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in estimated glomerular filtration rate (eGFR)
기간: 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
기간: 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
기간: 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
기간: Change between baseline and 8 weeks
|
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)
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Ilias Attaye, Dr., Erasmus Medical Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NL-010928
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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