Effect of Changes in Carbohydrate Intake Patterns on Glucose Control in Patients With Type 1 Diabetes

Обзор

The blood glucose fluctuates greatly in T1DM patients, especially in the middle and late stages of the disease, and carbohydrate (CHO) is the main determinant of postprandial glucose response (PGR). Based on the previous investigation to understand how nutritional habits affect blood glucose control, we will conduct dietary intervention studies in T1DM patients to explore whether the adjustment of dietary pattern is beneficial to blood glucose control, and further explore the relevant mechanism through the detection of related metabolic indicators.

Подробное описание

1\. Main Objective: To evaluate the effect of changes of carbohydrate intake on glucose control in patients with type 1 diabetes.

1. Primary endpoint: difference of time in range (TIR) between the 2 groups. 2. Secondary endpoint:

1\) difference of coefficient of variation (CV), mean amplitude of glycemic excursions (MAGE) , large amplitude of glycemic excursions (LAGE) between the 2 groups; 2) difference of change in HbA1c，GA，1,5-anhydroglucitol (1,5-AG) from baseline between the 2 groups; 3) difference of change in incidence of hypoglycemic events (%), severe hypoglycemia and nocturnal hypoglycemia events from baseline between the 2 groups; 4) difference of change in insulin dose (IU/kg/day) from baseline between the 2 groups.

2\. Secondary objective: To explore the possible mechanism of dietary intervention to improve blood glucose control in patients with type 1 diabetes.

1. Effects of dietary intervention on intestinal microenvironment and microflora of type 1 diabetes patients; 2. Effects of dietary intervention on immune function of type 1 diabetes patients; 3. Effects of dietary intervention on metabolomics of type 1 diabetes patients.

Вмешательства

• Другое diverse carbohydrate diet
  Carbohydrate provides 45\~55% of total dietary energy, protein 15\~20%, and fat 25 \~35%. Among them, 45\~50% of carbohydrate supply sources are refined grains, 45\~50% of carbohydrate supply sources are whole grains or beans. The total energy is divided into 3 meals per day. The breakfast provides 25\~30% of total energy, lunch 30\~40%，and dinner 30\~35%.
• Другое moderate carbohydrate diet
  Carbohydrate provides 45\~55% of total dietary energy, protein 15\~20%, and fat 25 \~35%. Among them, 90\~95% of carbohydrate supply sources are refined grains. The total energy is divided into 3 meals per day. The breakfast provides 25\~30% of total energy, lunch 30\~40%，and dinner 30\~35%.

Первичные конечные точки

• Time in range (TIR) [Срок оценки: Baseline to 2 weeks]

Вторичные конечные точки (12)

• Coefficient of variation of blood glucose（CV） [Срок оценки: Baseline to 2 weeks]
• Mean amplitude of glycemic excursions（MAGE） [Срок оценки: Baseline to 2 weeks]
• Large amplitude of glycemic excursions (LAGE) [Срок оценки: Baseline to 2 weeks]
• Change in HbA1c from baseline [Срок оценки: Baseline to 14 weeks]
• Change in GA（glycosylated albumin）from baseline [Срок оценки: Baseline to 2 weeks]
• Change in 1,5-anhydroglucitol (1,5-AG) from baseline [Срок оценки: Baseline to 2 weeks and to 14 weeks]
• Time above range(TAR) [Срок оценки: Baseline to 2 weeks]
• Time below range(TBR) [Срок оценки: Baseline to 2 weeks]
• Change in total insulin dose from baseline [Срок оценки: Baseline to 2 weeks and to 14 weeks]
• Change in blood lipids from baseline [Срок оценки: Baseline to 2 weeks and to 14 weeks]
• Change in body weight from baseline [Срок оценки: Baseline to 2 weeks and to 14 weeks]
• Daily mean glucose values [Срок оценки: Baseline to 2 weeks]

Критерии участия

Критерии включения

• Those who agree to participate in the study and sign informed consent;
• Diagnosis of type 1 diabetes mellitus (ADA2024);
• Age of 18\~70 years;
• Dependent on exogenous insulin therapy, the treatment plan remains unchanged within 2 months (the type of insulin cannot be changed, and the dose can be adjusted according to plasma glucose);
• Body mass index (BMI) of 18\~25kg/m2;
• HbA1c ≤11%;

Критерии исключения

• Honeymooners with type 1 diabetes mellitus;
• Women who are pregnant or plan to become pregnant;
• Patients who are vegetarians or are undergoing weight loss;
• Patients who are users of oral hypoglycemic drugs (alpha-glucosidase inhibitors, DPP-IV inhibitors, etc.);
• Patients who are users of glucocorticoids within 30 days;
• History of severe food allergy;
• Patients with acute complications such as DKA or HHS within six months;
• Patients with gastroparesis, inflammatory bowel disease and other complications;
• Patients with large albuminuria(albumin-to-creatinine ratio>34.09mg/mmol) and renal insufficiency(creatinine>200umol/L);
• Patients with uncontrolled hyperthyroidism and hypothyroidism(Uncontrolled hyperthyroidism is defined as abnormal TSH and T4. Uncontrolled hypothyroidism is defined as TSH > 10mIU/L.);
• History of heart disease, coronary heart disease and arrhythmia;
• Serious of liver dysfunction (ALT or AST>3 times the upper limit of normal);
• History of malignant tumors; History of tumors or surgeries affecting digestion and nutrient absorption; Patients with a history of benign tumors, which is judged by the physician to be not suitable;
• Patients with uncontrolled other immune system diseases or uncontrolled infections;
• Alcohol abuse, drug abuse, mental disorders or other conditions unfit to be an observer in drug tests;
• Patients with any disease likely to interfere with study participation or evaluation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• First Affiliated Hospital, Nanjing Medical University — Нанкин

Публикации

• 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. PMID 34836409
• 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. PMID 34212475
• 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. PMID 34836071
• 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. PMID 34513096
• 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. PMID 30122560
• 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. PMID 25630525
• 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. PMID 11836274
• 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. PMID 30351201

Идентификаторы

NCT: NCT06273631 · 2022-SR-481.A2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗