Effekt af ændringer i kulhydratindtag på glukosekontrol hos patienter med type 1-diabetes
7. september 2026 opdateret af: Yang Tao
Effekt af ændringer i kulhydratindtag på glukosekontrol hos patienter med type 1-diabetes.
Blodsukkeret svinger meget hos T1DM-patienter, især i de midterste og sene stadier af sygdommen, og kulhydrat (CHO) er hoveddeterminanten for postprandial glukoserespons (PGR).
Baseret på den tidligere undersøgelse for at forstå, hvordan ernæringsvaner påvirker blodsukkerkontrol, vil vi udføre diætinterventionsundersøgelser i T1DM-patienter for at undersøge, om justeringen af kostmønsteret er gavnligt for blodsukkerkontrol, og yderligere udforske den relevante mekanisme gennem påvisning af relaterede metaboliske indikatorer.
Studieoversigt
Status
Status
Rekruttering
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
1. Hovedformål: At evaluere effekten af ændringer i kulhydratindtaget på glukosekontrol hos patienter med type 1-diabetes.
- Primært endepunkt: tidsforskel (TIR) mellem de 2 grupper.
- Sekundært endepunkt:
1) forskel i variationskoefficient (CV), gennemsnitlig amplitude af glykæmiske udsving (MAGE), stor amplitude af glykæmiske udsving (LAGE) mellem de 2 grupper; 2) forskel i ændring i HbA1c, GA, 1,5-anhydroglucitol (1,5-AG) fra baseline mellem de 2 grupper; 3) forskel i ændring i forekomst af hypoglykæmiske hændelser (%), svær hypoglykæmi og natlig hypoglykæmi fra baseline mellem de 2 grupper; 4) forskel på ændring i insulindosis (IE/kg/dag) fra baseline mellem de 2 grupper.
2. Sekundært mål: At udforske den mulige mekanisme for diætintervention for at forbedre blodsukkerkontrollen hos patienter med type 1-diabetes.
- Effekter af diætintervention på tarmmikromiljø og mikroflora hos type 1-diabetespatienter;
- Effekter af diætintervention på immunfunktionen hos type 1-diabetespatienter;
- Effekter af diætintervention på metabolomik hos type 1-diabetespatienter.
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
Tilmelding
80
Fase
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
Studiekontakt
- Navn: Tao Yang, MD/PhD
- Telefonnummer: 6466 86-25-83718836
- E-mail: yangt@njmu.edu.cn
Studiesteder
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210029
- Rekruttering
- First Affiliated Hospital, Nanjing Medical University
-
Kontakt:
- Tao Yang, PhD
- Telefonnummer: 6466 86-25-83718836
- E-mail: yangt@njmu.edu.cn
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- De, der accepterer at deltage i undersøgelsen og underskriver informeret samtykke;
- Diagnose af type 1 diabetes mellitus (ADA2024);
- Alder 18~65 år;
- Afhængig af eksogen insulinbehandling (CSII) forbliver behandlingsplanen uændret inden for 2 måneder (insulintypen kan ikke ændres, og dosis kan justeres i henhold til plasmaglukose);
- Kropsmasseindeks (BMI) på 18~24 kg/m2;
- HbA1c ≤9,5%;
- Tilfældigt C-peptid ≥200 pmol/L.
Ekskluderingskriterier:
- Bryllupsrejsende med type 1-diabetes mellitus;
- Kvinder, der er gravide eller planlægger at blive gravide;
- Patienter, der er vegetarer;
- Patienter, der bruger orale hypoglykæmiske lægemidler (alfa-glucosidasehæmmere, DPP-IV-hæmmere osv.);
- Patienter, der er brugere af glukokortikoider inden for 30 dage;
- Anamnese med alvorlig fødevareallergi;
- Patienter med akutte komplikationer såsom DKA;
- Patienter med gastroparese, inflammatorisk tarmsygdom og andre komplikationer;
- Patienter med stor albuminuri og nyreinsufficiens;
- Patienter med ukontrolleret hyperthyroidisme og hypothyroidisme;
- Anamnese med hjertesygdomme, koronar hjertesygdom og arytmi;
- Alvorlig leverdysfunktion (ALT eller AST>1,5 gange den øvre normalgrænse);
- Anamnese med maligne tumorer, ukontrollerede andre immunsystemsygdomme, ukontrollerede infektioner;
- Alkoholmisbrug, psykiske lidelser eller andre forhold, der er uegnede til at være observatør i stoftests;
- Patienter med enhver sygdom, der sandsynligvis vil forstyrre undersøgelsesdeltagelse eller evaluering.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Antal våben
2
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: 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%.
|
|
Andet: 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%.
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time in range (TIR)
Tidsramme: 4 weeks (2 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization)
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time above range(TAR)
Tidsramme: 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.
|
4 weeks (2 weeks after randomization)
|
|
Time below range(TBR)
Tidsramme: 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.
|
4 weeks (2 weeks after randomization)
|
|
Mean glucose (MG)
Tidsramme: 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.
|
4 weeks (2 weeks after randomization)
|
|
Standard deviation of glucose (SD)
Tidsramme: 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.
|
4 weeks (2 weeks after randomization)
|
|
Glucose coefficient of variation (CV)
Tidsramme: 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.
|
4 weeks (2 weeks after randomization)
|
|
Mean amplitude of glycemic excursions (MAGE)
Tidsramme: 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.
|
4 weeks (2 weeks after randomization)
|
|
Largest amplitude of glycemic excursions (LAGE)
Tidsramme: 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.
|
4 weeks (2 weeks after randomization)
|
|
Glycated albumin (GA)
Tidsramme: 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.
|
4 weeks (2 weeks after randomization)
|
|
Glycated hemoglobin A1c (HbA1c)
Tidsramme: 16 weeks (14 weeks after randomization)
|
HbA1c will be measured at the end of the follow-up period and compared between the two groups.
|
16 weeks (14 weeks after randomization)
|
|
C-peptide area under the curve (AUC C-peptide)
Tidsramme: 16 weeks (14 weeks after randomization)
|
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.
|
16 weeks (14 weeks after randomization)
|
|
Glucagon area under the curve (AUC glucagon)
Tidsramme: 16 weeks (14 weeks after randomization)
|
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.
|
16 weeks (14 weeks after randomization)
|
|
Fasting blood glucose (FBG)
Tidsramme: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Total cholesterol (TC)
Tidsramme: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Triglycerides (TG)
Tidsramme: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Low-density lipoprotein cholesterol (LDL-C)
Tidsramme: 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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
High-density lipoprotein cholesterol (HDL-C)
Tidsramme: 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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
1,5-Anhydroglucitol (1,5-AG)
Tidsramme: 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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Total daily insulin dose
Tidsramme: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Basal insulin dose
Tidsramme: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Prandial insulin dose
Tidsramme: 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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Body weight
Tidsramme: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Body weight will be measured at the end of the dietary intervention and at the end of the follow-up period.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Waist circumference
Tidsramme: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Waist circumference will be measured at the end of the dietary intervention and at the end of the follow-up period.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Hip circumference
Tidsramme: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Hip circumference will be measured at the end of the dietary intervention and at the end of the follow-up period.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Waist-to-hip ratio (WHR)
Tidsramme: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Body composition
Tidsramme: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Hypoglycemic events
Tidsramme: From randomization to the end of follow-up at 16 weeks
|
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.
|
From randomization to the end of follow-up at 16 weeks
|
|
Diabetic ketoacidosis (DKA)
Tidsramme: 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
|
Andre resultatmål
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Gut microbiota profile
Tidsramme: 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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Metabolomic profile
Tidsramme: 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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
T-cell subset proportions
Tidsramme: 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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Ledende efterforsker: Tao Yang, MD/PhD, First Affiliated Hospital, Nanjing Medical University, China
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Hollowell JG, Staehling NW, Flanders WD, Hannon WH, Gunter EW, Spencer CA, Braverman LE. Serum TSH, T(4), and thyroid antibodies in the United States population (1988 to 1994): National Health and Nutrition Examination Survey (NHANES III). J Clin Endocrinol Metab. 2002 Feb;87(2):489-99. doi: 10.1210/jcem.87.2.8182.
- 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.
- Zhai X, Zhang L, Chen L, Lian X, Liu C, Shi B, Shi L, Tong N, Wang S, Weng J, Zhao J, Teng X, Yu X, Lai Y, Wang W, Li C, Mao J, Li Y, Fan C, Li L, Shan Z, Teng W. An Age-Specific Serum Thyrotropin Reference Range for the Diagnosis of Thyroid Diseases in Older Adults: A Cross-Sectional Survey in China. Thyroid. 2018 Dec;28(12):1571-1579. doi: 10.1089/thy.2017.0715. Epub 2018 Nov 27.
- Wong K, Raffray M, Roy-Fleming A, Blunden S, Brazeau AS. Ketogenic Diet as a Normal Way of Eating in Adults With Type 1 and Type 2 Diabetes: A Qualitative Study. Can J Diabetes. 2021 Mar;45(2):137-143.e1. doi: 10.1016/j.jcjd.2020.06.016. Epub 2020 Jun 27.
- 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.
- Vetrani C, Calabrese I, Cavagnuolo L, Pacella D, Napolano E, Di Rienzo S, Riccardi G, Rivellese AA, Annuzzi G, Bozzetto L. Dietary determinants of postprandial blood glucose control in adults with type 1 diabetes on a hybrid closed-loop system. Diabetologia. 2022 Jan;65(1):79-87. doi: 10.1007/s00125-021-05587-0. Epub 2021 Oct 23.
- Kanikarla-Marie P, Jain SK. Hyperketonemia and ketosis increase the risk of complications in type 1 diabetes. Free Radic Biol Med. 2016 Jun;95:268-77. doi: 10.1016/j.freeradbiomed.2016.03.020. Epub 2016 Mar 29.
- Bolla AM, Caretto A, Laurenzi A, Scavini M, Piemonti L. Low-Carb and Ketogenic Diets in Type 1 and Type 2 Diabetes. Nutrients. 2019 Apr 26;11(5):962. doi: 10.3390/nu11050962.
- Dabek A, Wojtala M, Pirola L, Balcerczyk A. Modulation of Cellular Biochemistry, Epigenetics and Metabolomics by Ketone Bodies. Implications of the Ketogenic Diet in the Physiology of the Organism and Pathological States. Nutrients. 2020 Mar 17;12(3):788. doi: 10.3390/nu12030788.
- Zinn C, Lenferna De La Motte KA, Rush A, Johnson R. Assessing the Nutrient Status of Low Carbohydrate, High-Fat (LCHF) Meal Plans in Children: A Hypothetical Case Study Design. Nutrients. 2022 Apr 12;14(8):1598. doi: 10.3390/nu14081598.
- Pasmans K, Meex RCR, van Loon LJC, Blaak EE. Nutritional strategies to attenuate postprandial glycemic response. Obes Rev. 2022 Sep;23(9):e13486. doi: 10.1111/obr.13486. Epub 2022 Jun 10.
- Saslow LR, Mason AE, Kim S, Goldman V, Ploutz-Snyder R, Bayandorian H, Daubenmier J, Hecht FM, Moskowitz JT. An Online Intervention Comparing a Very Low-Carbohydrate Ketogenic Diet and Lifestyle Recommendations Versus a Plate Method Diet in Overweight Individuals With Type 2 Diabetes: A Randomized Controlled Trial. J Med Internet Res. 2017 Feb 13;19(2):e36. doi: 10.2196/jmir.5806.
- Rydin AA, Spiegel G, Frohnert BI, Kaess A, Oswald L, Owen D, Simmons KM. Medical management of children with type 1 diabetes on low-carbohydrate or ketogenic diets. Pediatr Diabetes. 2021 May;22(3):448-454. doi: 10.1111/pedi.13179. Epub 2021 Feb 16.
- Turton JL, Raab R, Rooney KB. Low-carbohydrate diets for type 1 diabetes mellitus: A systematic review. PLoS One. 2018 Mar 29;13(3):e0194987. doi: 10.1371/journal.pone.0194987. eCollection 2018.
- Bell E, Binkowski S, Sanderson E, Keating B, Smith G, Harray AJ, Davis EA. Substantial Intra-Individual Variability in Post-Prandial Time to Peak in Controlled and Free-Living Conditions in Children with Type 1 Diabetes. Nutrients. 2021 Nov 19;13(11):4154. doi: 10.3390/nu13114154.
- Clark AL, Yan Z, Chen SX, Shi V, Kulkarni DH, Diwan A, Remedi MS. High-fat diet prevents the development of autoimmune diabetes in NOD mice. Diabetes Obes Metab. 2021 Nov;23(11):2455-2465. doi: 10.1111/dom.14486. Epub 2021 Aug 2.
- Lejk A, Chrzanowski J, Cieslak A, Fendler W, Mysliwiec M. Effect of Nutritional Habits on the Glycemic Response to Different Carbohydrate Diet in Children with Type 1 Diabetes Mellitus. Nutrients. 2021 Oct 27;13(11):3815. doi: 10.3390/nu13113815.
- Thewjitcharoen Y, Wanothayaroj E, Jaita H, Nakasatien S, Butadej S, Khurana I, Maxwell S, El-Osta A, Chatchomchuan W, Krittiyawong S, Himathongkam T. Prolonged Honeymoon Period in a Thai Patient with Adult-Onset Type 1 Diabetes Mellitus. Case Rep Endocrinol. 2021 Sep 1;2021:3511281. doi: 10.1155/2021/3511281. eCollection 2021.
- Jaacks LM, Crandell J, Mendez MA, Lamichhane AP, Liu W, Ji L, Du S, Rosamond W, Popkin BM, Mayer-Davis EJ. Dietary patterns associated with HbA1c and LDL cholesterol among individuals with type 1 diabetes in China. J Diabetes Complications. 2015 Apr;29(3):343-9. doi: 10.1016/j.jdiacomp.2014.12.014. Epub 2014 Dec 31.
- Barouti AA, Bjorklund A, Catrina SB, Brismar K, Rajamand Ekberg N. Effect of Isocaloric Meals on Postprandial Glycemic and Metabolic Markers in Type 1 Diabetes-A Randomized Crossover Trial. Nutrients. 2023 Jul 10;15(14):3092. doi: 10.3390/nu15143092.
- Berry SE, Valdes AM, Drew DA, Asnicar F, Mazidi M, Wolf J, Capdevila J, Hadjigeorgiou G, Davies R, Al Khatib H, Bonnett C, Ganesh S, Bakker E, Hart D, Mangino M, Merino J, Linenberg I, Wyatt P, Ordovas JM, Gardner CD, Delahanty LM, Chan AT, Segata N, Franks PW, Spector TD. Human postprandial responses to food and potential for precision nutrition. Nat Med. 2020 Jun;26(6):964-973. doi: 10.1038/s41591-020-0934-0. Epub 2020 Jun 11.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
1. august 2024
Primær færdiggørelse (Anslået)
Primær færdiggørelse
31. december 2027
Studieafslutning (Anslået)
Studieafslutning
31. december 2027
Datoer for studieregistrering
Først indsendt
Først indsendt
23. februar 2023
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
16. februar 2024
Først opslået (Faktiske)
Først opslået
22. februar 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
10. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. september 2026
Sidst verificeret
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 2022-SR-481.A3
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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