- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Ilias Attaye, Dr.
- Telefoonnummer: +31 10 704 0704
- E-mail: i.attaye@erasmusmc.nl
Studie Locaties
-
-
-
Rotterdam, Nederland
- Erasmus Medical Center
-
Contact:
- Ilias Attaye, Dr.
- Telefoonnummer: +31 10 704 0704
- E-mail: i.attaye@erasmusmc.nl
-
Hoofdonderzoeker:
- Ilias Attaye, Dr.
-
Onderonderzoeker:
- Dagmar Dekker, MSc
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Geen tussenkomst: 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)
|
|
|
Experimenteel: Low Dietary Acid Load
This arm will follow a DAL lowering diet with the aim to reach <25mEq H⁺/day
|
This arm will follow a DAL lowering diet with the aim to reach <25mEq H⁺/day
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage change in urinary albumin-to-creatinine ratio (UACR)
Tijdsspanne: Change between baseline and 8 weeks
|
Log-transformed urinary albumin-to-creatinine ratio (UACR), following an 8-week dietary intervention.
|
Change between baseline and 8 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in estimated glomerular filtration rate (eGFR)
Tijdsspanne: Change between baseline and 8 weeks
|
eGFR calculated using serum creatinine and/or cystatin C
|
Change between baseline and 8 weeks
|
|
Change in serum bicarbonate
Tijdsspanne: Change between baseline and 8 weeks
|
Serum bicarbonate concentration measured in blood
|
Change between baseline and 8 weeks
|
|
Change in urinary citrate
Tijdsspanne: Change between baseline and 8 weeks
|
Urinary citrate excretion measured in 24-hour urine collections
|
Change between baseline and 8 weeks
|
|
Glucose response during Oral Glucose Tolerance Test
Tijdsspanne: Change between baseline and 8 weeks
|
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)
Tijdsspanne: Change between baseline and 8 weeks
|
Mean amplitude of glycemic excursions (MAGE) derived from continuous glucose monitoring (CGM) data.
|
Change between baseline and 8 weeks
|
|
Change in gut microbiota composition
Tijdsspanne: Change between baseline and 8 weeks
|
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
Tijdsspanne: Change between baseline and 8 weeks
|
Serum metabolite profiles measured using untargeted metabolomics analysis.
|
Change between baseline and 8 weeks
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Ilias Attaye, Dr., Erasmus Medical Center
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Endocriene systeemziekten
- Pathologische processen
- Mannelijke urogenitale ziekten
- Nier Ziekten
- Urologische ziekten
- Vrouwelijke urogenitale ziekten
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Chronische ziekte
- Ziekte attributen
- Metabole ziekten
- Glucosemetabolismestoornissen
- Suikerziekte
- Nierinsufficiëntie
- Pathologische aandoeningen, tekenen en symptomen
- Voedings- en stofwisselingsziekten
- Diabetes mellitus, type 2
- Nierinsufficiëntie, chronisch
Andere studie-ID-nummers
- NL-010928
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .