- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT06273631
Vliv změn v příjmu sacharidů na kontrolu glukózy u pacientů s diabetem 1. typu
Vliv změn v příjmu sacharidů na kontrolu glukózy u pacientů s diabetem 1. typu.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
1. Hlavní cíl: Zhodnotit vliv změn příjmu sacharidů na kontrolu glukózy u pacientů s diabetem 1. typu.
- Primární cíl: rozdíl času v rozsahu (TIR) mezi těmito 2 skupinami.
- Sekundární koncový bod:
1) rozdíl variačního koeficientu (CV), střední amplitudy glykemických odchylek (MAGE), velké amplitudy glykemických odchylek (LAGE) mezi 2 skupinami; 2) rozdíl ve změně HbA1c,GA,1,5-anhydroglucitolu (1,5-AG) od výchozí hodnoty mezi 2 skupinami; 3) rozdíl ve změně výskytu hypoglykemických příhod (%), závažných hypoglykemických příhod a nočních hypoglykemických příhod od výchozí hodnoty mezi těmito 2 skupinami; 4) rozdíl ve změně dávky inzulínu (IU/kg/den) od výchozí hodnoty mezi dvěma skupinami.
2. Sekundární cíl: Prozkoumat možný mechanismus dietní intervence ke zlepšení kontroly glukózy v krvi u pacientů s diabetem 1. typu.
- Účinky dietní intervence na střevní mikroprostředí a mikroflóru pacientů s diabetem 1. typu;
- Účinky dietní intervence na imunitní funkce pacientů s diabetem 1. typu;
- Účinky dietní intervence na metabolomiku pacientů s diabetem 1. typu.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Tao Yang, MD/PhD
- Telefonní číslo: 6466 86-25-83718836
- E-mail: yangt@njmu.edu.cn
Studijní místa
-
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Jiangsu
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Nanjing, Jiangsu, Čína, 210029
- Nábor
- First Affiliated Hospital, Nanjing Medical University
-
Kontakt:
- Tao Yang, PhD
- Telefonní číslo: 6466 86-25-83718836
- E-mail: yangt@njmu.edu.cn
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Kritéria pro zařazení:
- Ti, kteří souhlasí s účastí ve studii a podepíší informovaný souhlas;
- Diagnóza diabetes mellitus 1. typu (ADA2024);
- Věk 18~65 let;
- V závislosti na exogenní inzulínové terapii (CSII) zůstává léčebný plán do 2 měsíců nezměněn (typ inzulínu nelze měnit, dávku lze upravit podle plazmatické glukózy);
- Index tělesné hmotnosti (BMI) 18~24 kg/m2;
- HbAlc < 9,5 %;
- Náhodný C-peptid ≥200 pmol/l.
Kritéria vyloučení:
- novomanželé na svatební cestě s diabetes mellitus 1. typu;
- Ženy, které jsou těhotné nebo plánují otěhotnět;
- Pacienti, kteří jsou vegetariáni;
- Pacienti, kteří užívají perorální hypoglykemická léčiva (inhibitory alfa-glukosidázy, inhibitory DPP-IV atd.);
- Pacienti, kteří užívají glukokortikoidy do 30 dnů;
- Závažná potravinová alergie v anamnéze;
- Pacienti s akutními komplikacemi, jako je DKA;
- Pacienti s gastroparézou, zánětlivým onemocněním střev a dalšími komplikacemi;
- Pacienti s velkou albuminurií a renální insuficiencí;
- Pacienti s nekontrolovanou hypertyreózou a hypotyreózou;
- Srdeční onemocnění, ischemická choroba srdeční a arytmie v anamnéze;
- Závažná porucha funkce jater (ALT nebo AST > 1,5násobek horní hranice normy);
- Zhoubné nádory v anamnéze, nekontrolovaná jiná onemocnění imunitního systému, nekontrolované infekce;
- Zneužívání alkoholu, duševní poruchy nebo jiné stavy nezpůsobilé být pozorovatelem v testech na drogy;
- Pacienti s jakýmkoli onemocněním, které by mohlo narušit účast ve studii nebo hodnocení.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Jiný: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Time in range (TIR)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Time above range(TAR)
Časové okno: 4 weeks (2 weeks after randomization)
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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)
Časové okno: 4 weeks (2 weeks after randomization)
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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)
Časové okno: 4 weeks (2 weeks after randomization)
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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)
Časové okno: 4 weeks (2 weeks after randomization)
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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)
Časové okno: 4 weeks (2 weeks after randomization)
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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)
Časové okno: 4 weeks (2 weeks after randomization)
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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)
Časové okno: 4 weeks (2 weeks after randomization)
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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)
Časové okno: 4 weeks (2 weeks after randomization)
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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)
Časové okno: 16 weeks (14 weeks after randomization)
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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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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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)
Časové okno: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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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)
Časové okno: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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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
Časové okno: 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
Časové okno: 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
Časové okno: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: From randomization to the end of follow-up at 16 weeks
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The number and proportion of participants experiencing diabetic ketoacidosis will be assessed and compared between the two groups.
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From randomization to the end of follow-up at 16 weeks
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Gut microbiota profile
Časové okno: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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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
Časové okno: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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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
Časové okno: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Tao Yang, MD/PhD, First Affiliated Hospital, Nanjing Medical University, China
Publikace a užitečné odkazy
Obecné publikace
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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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- 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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Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2022-SR-481.A3
Informace o lécích a zařízeních, studijní dokumenty
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