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Effect van veranderingen in de koolhydraatinname op de glucosecontrole bij patiënten met diabetes type 1
Effect van veranderingen in de koolhydraatinname op de glucosecontrole bij patiënten met type 1 diabetes.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
1. Hoofddoel: Het evalueren van het effect van veranderingen in de koolhydraatinname op de glucoseregulatie bij patiënten met type 1-diabetes.
- Primair eindpunt: verschil in tijd binnen bereik (TIR) tussen de twee groepen.
- Secundair eindpunt:
1) verschil in variatiecoëfficiënt (CV), gemiddelde amplitude van glycemische excursies (MAGE), grote amplitude van glycemische excursies (LAGE) tussen de 2 groepen; 2) verschil in verandering in HbA1c, GA, 1,5-anhydroglucitol (1,5-AG) ten opzichte van de uitgangswaarde tussen de 2 groepen; 3) verschil in verandering in de incidentie van hypoglykemische voorvallen (%), ernstige hypoglykemie en nachtelijke hypoglykemie ten opzichte van de uitgangssituatie tussen de twee groepen; 4) Verschil in verandering in insulinedosis (IE/kg/dag) ten opzichte van de uitgangswaarde tussen de 2 groepen.
2. Secundaire doelstelling: Het mogelijke mechanisme van dieetinterventie onderzoeken om de bloedglucoseregulatie bij patiënten met type 1 diabetes te verbeteren.
- Effecten van voedingsinterventie op de darmmicroomgeving en microflora van type 1 diabetespatiënten;
- Effecten van voedingsinterventie op de immuunfunctie van type 1 diabetespatiënten;
- Effecten van voedingsinterventies op de metabolomics van type 1-diabetespatiënten.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Tao Yang, MD/PhD
- Telefoonnummer: 6466 86-25-83718836
- E-mail: yangt@njmu.edu.cn
Studie Locaties
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Jiangsu
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Nanjing, Jiangsu, China, 210029
- Werving
- First Affiliated Hospital, Nanjing Medical University
-
Contact:
- Tao Yang, PhD
- Telefoonnummer: 6466 86-25-83718836
- E-mail: yangt@njmu.edu.cn
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusiecriteria:
- Degenen die ermee instemmen deel te nemen aan het onderzoek en geïnformeerde toestemming ondertekenen;
- Diagnose van diabetes mellitus type 1 (ADA2024);
- Leeftijd van 18~65 jaar;
- Afhankelijk van de exogene insulinetherapie (CSII) blijft het behandelplan binnen 2 maanden ongewijzigd (het type insuline kan niet worden gewijzigd en de dosis kan worden aangepast op basis van de plasmaglucose);
- Body mass index (BMI) van 18~24 kg/m2;
- HbA1c ≤9,5%;
- Willekeurig C-peptide ≥200 pmol/L.
Uitsluitingscriteria:
- Pasgetrouwden met diabetes mellitus type 1;
- Vrouwen die zwanger zijn of van plan zijn zwanger te worden;
- Patiënten die vegetariër zijn;
- Patiënten die orale hypoglycemische geneesmiddelen gebruiken (alfaglucosidaseremmers, DPP-IV-remmers, enz.);
- Patiënten die binnen 30 dagen glucocorticoïden gebruiken;
- Geschiedenis van ernstige voedselallergie;
- Patiënten met acute complicaties zoals DKA;
- Patiënten met gastroparese, inflammatoire darmaandoeningen en andere complicaties;
- Patiënten met grote albuminurie en nierinsufficiëntie;
- Patiënten met ongecontroleerde hyperthyreoïdie en hypothyreoïdie;
- Geschiedenis van hartziekten, coronaire hartziekten en aritmie;
- Ernstige leverdisfunctie (ALT of AST>1,5 keer de bovengrens van normaal);
- Geschiedenis van kwaadaardige tumoren, ongecontroleerde andere immuunsysteemziekten, ongecontroleerde infecties;
- Alcoholmisbruik, psychische stoornissen of andere aandoeningen die niet geschikt zijn om als waarnemer te fungeren bij drugstests;
- Patiënten met een ziekte die waarschijnlijk de deelname aan het onderzoek of de evaluatie ervan zal verstoren.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: diverse carbohydrate diet
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively. Of the staple carbohydrate sources, 45-50% are derived from refined grains and 45-50% from whole grains and legumes. Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%. |
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively.
Of the staple carbohydrate sources, 45-50% are derived from refined grains and 45-50% from whole grains and legumes.
Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%.
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Ander: moderate carbohydrate diet
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively. Of the staple carbohydrate sources, 90-95% are derived from refined grains. Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%. |
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively.
Of the staple carbohydrate sources, 90-95% are derived from refined grains.
Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Time in range (TIR)
Tijdsspanne: 4 weeks (2 weeks after randomization)
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TIR is defined as the percentage of time that glucose levels are between 3.9 and 10.0 mmol/L, as measured by continuous glucose monitoring (CGM).
TIR at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Time above range(TAR)
Tijdsspanne: 4 weeks (2 weeks after randomization)
|
TAR is defined as the percentage of time that glucose levels are above 10.0 mmol/L, as measured using continuous glucose monitoring (CGM).
TAR at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Time below range(TBR)
Tijdsspanne: 4 weeks (2 weeks after randomization)
|
TBR is defined as the percentage of time that glucose levels are below 3.9 mmol/L, as measured using continuous glucose monitoring (CGM).
TBR at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Mean glucose (MG)
Tijdsspanne: 4 weeks (2 weeks after randomization)
|
Mean glucose is defined as the arithmetic mean of all valid glucose values recorded during the 2-week continuous glucose monitoring (CGM) period.
Mean glucose at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Standard deviation of glucose (SD)
Tijdsspanne: 4 weeks (2 weeks after randomization)
|
SD is a continuous glucose monitoring (CGM)-derived measure of glycemic variability.
SD at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Glucose coefficient of variation (CV)
Tijdsspanne: 4 weeks (2 weeks after randomization)
|
CV is a continuous glucose monitoring (CGM)-derived measure of glycemic variability.
CV at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Mean amplitude of glycemic excursions (MAGE)
Tijdsspanne: 4 weeks (2 weeks after randomization)
|
MAGE is a continuous glucose monitoring (CGM)-derived measure of glycemic variability.
MAGE at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Largest amplitude of glycemic excursions (LAGE)
Tijdsspanne: 4 weeks (2 weeks after randomization)
|
LAGE is a continuous glucose monitoring (CGM)-derived measure of glycemic variability.
LAGE at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Glycated albumin (GA)
Tijdsspanne: 4 weeks (2 weeks after randomization)
|
Glycated albumin will be measured at the end of the 2-week dietary intervention and compared between the two groups.
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4 weeks (2 weeks after randomization)
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Glycated hemoglobin A1c (HbA1c)
Tijdsspanne: 16 weeks (14 weeks after randomization)
|
HbA1c will be measured at the end of the follow-up period and compared between the two groups.
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16 weeks (14 weeks after randomization)
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C-peptide area under the curve (AUC C-peptide)
Tijdsspanne: 16 weeks (14 weeks after randomization)
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C-peptide area under the curve will be assessed during a 3-hour mixed-meal tolerance test and calculated using the trapezoidal rule.
The assessment will be performed in participants with fasting C-peptide >80 pmol/L.
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16 weeks (14 weeks after randomization)
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Glucagon area under the curve (AUC glucagon)
Tijdsspanne: 16 weeks (14 weeks after randomization)
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Glucagon area under the curve will be assessed during a 3-hour mixed-meal tolerance test and calculated using the trapezoidal rule.
The assessment will be performed in participants with fasting C-peptide >80 pmol/L.
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16 weeks (14 weeks after randomization)
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Fasting blood glucose (FBG)
Tijdsspanne: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Fasting blood glucose will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Total cholesterol (TC)
Tijdsspanne: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Total cholesterol will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Triglycerides (TG)
Tijdsspanne: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Triglycerides will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Low-density lipoprotein cholesterol (LDL-C)
Tijdsspanne: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
LDL-C will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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High-density lipoprotein cholesterol (HDL-C)
Tijdsspanne: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
HDL-C will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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1,5-Anhydroglucitol (1,5-AG)
Tijdsspanne: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
1,5-AG will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Total daily insulin dose
Tijdsspanne: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Total daily insulin dose, expressed as IU/kg/day, will be assessed at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Basal insulin dose
Tijdsspanne: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Basal insulin dose, expressed as IU/kg/day, will be assessed at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Prandial insulin dose
Tijdsspanne: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Prandial insulin dose, expressed as IU/kg/day, will be assessed at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Body weight
Tijdsspanne: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Body weight will be measured at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Waist circumference
Tijdsspanne: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Waist circumference will be measured at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Hip circumference
Tijdsspanne: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Hip circumference will be measured at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Waist-to-hip ratio (WHR)
Tijdsspanne: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Waist-to-hip ratio will be calculated from waist and hip circumference measurements at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Body composition
Tijdsspanne: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Body composition will be assessed using a body composition analyzer at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Hypoglycemic events
Tijdsspanne: From randomization to the end of follow-up at 16 weeks
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Hypoglycemic events will be assessed by the number of events per participant, the proportion of participants experiencing at least one hypoglycemic event, and the incidence rate of hypoglycemic events.
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From randomization to the end of follow-up at 16 weeks
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Diabetic ketoacidosis (DKA)
Tijdsspanne: From randomization to the end of follow-up at 16 weeks
|
The number and proportion of participants experiencing diabetic ketoacidosis will be assessed and compared between the two groups.
|
From randomization to the end of follow-up at 16 weeks
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Gut microbiota profile
Tijdsspanne: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Gut microbiota profiles will be assessed from fecal samples at the end of the dietary intervention and at the end of the follow-up period to evaluate differences between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Metabolomic profile
Tijdsspanne: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Metabolomic profiles will be assessed at the end of the dietary intervention and at the end of the follow-up period to evaluate differences between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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T-cell subset proportions
Tijdsspanne: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
The proportions of T-cell subsets will be assessed by flow cytometry at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Tao Yang, MD/PhD, First Affiliated Hospital, Nanjing Medical University, China
Publicaties en nuttige links
Algemene publicaties
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- Seidelmann SB, Claggett B, Cheng S, Henglin M, Shah A, Steffen LM, Folsom AR, Rimm EB, Willett WC, Solomon SD. Dietary carbohydrate intake and mortality: a prospective cohort study and meta-analysis. Lancet Public Health. 2018 Sep;3(9):e419-e428. doi: 10.1016/S2468-2667(18)30135-X. Epub 2018 Aug 17.
- Smart CE, Evans M, O'Connell SM, McElduff P, Lopez PE, Jones TW, Davis EA, King BR. Both dietary protein and fat increase postprandial glucose excursions in children with type 1 diabetes, and the effect is additive. Diabetes Care. 2013 Dec;36(12):3897-902. doi: 10.2337/dc13-1195. Epub 2013 Oct 29.
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- Buehler LA, Noe D, Knapp S, Isaacs D, Pantalone KM. Ketogenic diets in the management of type 1 diabetes: Safe or safety concern? Cleve Clin J Med. 2021 Oct 1;88(10):547-555. doi: 10.3949/ccjm.88a.20121.
- Leow ZZX, Guelfi KJ, Davis EA, Jones TW, Fournier PA. The glycaemic benefits of a very-low-carbohydrate ketogenic diet in adults with Type 1 diabetes mellitus may be opposed by increased hypoglycaemia risk and dyslipidaemia. Diabet Med. 2018 May 8. doi: 10.1111/dme.13663. Online ahead of print.
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Studieregistratiedata
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2022-SR-481.A3
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