- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Ilias Attaye, Dr.
- Telefonnummer: +31 10 704 0704
- E-mail: i.attaye@erasmusmc.nl
Studiesteder
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-
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Rotterdam, Holland
- Erasmus Medical Center
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Kontakt:
- Ilias Attaye, Dr.
- Telefonnummer: +31 10 704 0704
- E-mail: i.attaye@erasmusmc.nl
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Ledende efterforsker:
- Ilias Attaye, Dr.
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Underforsker:
- Dagmar Dekker, MSc
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: 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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|
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Eksperimentel: 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
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage change in urinary albumin-to-creatinine ratio (UACR)
Tidsramme: Change between baseline and 8 weeks
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Log-transformed urinary albumin-to-creatinine ratio (UACR), following an 8-week dietary intervention.
|
Change between baseline and 8 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in estimated glomerular filtration rate (eGFR)
Tidsramme: 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
Tidsramme: 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
|
|
Change in urinary citrate
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Ilias Attaye, Dr., Erasmus Medical Center
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Sygdomme i det endokrine system
- Patologiske processer
- Mandlige urogenitale sygdomme
- Nyresygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Kronisk sygdom
- Sygdomsegenskaber
- Metaboliske sygdomme
- Glukosemetabolismeforstyrrelser
- Diabetes mellitus
- Nyreinsufficiens
- Patologiske tilstande, tegn og symptomer
- Ernæringsmæssige og metaboliske sygdomme
- Diabetes mellitus, type 2
- Nyreinsufficiens, kronisk
Andre undersøgelses-id-numre
- NL-010928
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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