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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06273631
• Other study ID #: 2022-SR-481
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Nanjing Medical University
• Contact: Tao Yang, MD/PhD
• Phone: 86-25-83718836
• Email: yangt[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Those who agree to participate in the study and sign informed consent;

2. Diagnosis of type 1 diabetes mellitus (ADA2024);

3. Age of 18~65 years;

4. 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);

5. Body mass index (BMI) of 18~25kg/m2;

6. HbA1c =11%;

Exclusion Criteria:

1. Honeymooners with type 1 diabetes mellitus;

2. Women who are pregnant or plan to become pregnant;

3. Patients who are vegetarians;

4. Patients who are users of oral hypoglycemic drugs (alpha-glucosidase inhibitors, DPP-IV inhibitors, etc.);

5. Patients who are users of glucocorticoids within 30 days;

6. History of severe food allergy;

7. Patients with acute complications such as DKA;

8. Patients with gastroparesis, inflammatory bowel disease and other complications;

9. Patients with large albuminuria and renal insufficiency;

10. Patients with uncontrolled hyperthyroidism and hypothyroidism;

11. History of heart disease, coronary heart disease and arrhythmia;

12. Serious of liver dysfunction (ALT or AST>3 times the upper limit of normal);

13. History of malignant tumors, uncontrolled other immune system diseases, uncontrolled infections;

14. Alcohol abuse, mental disorders or other conditions unfit to be an observer in drug tests;

15. Patients with any disease likely to interfere with study participation or evaluation.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diet Intervention
• Glucose Control
• Type 1 Diabetes

Intervention

Other:
• diverse carbohydrate diet
Carbohydrate provides 50~55% of total dietary energy, protein 10~15%, and fat 20 ~30%. 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%.
• middle carbohydrate diet
Carbohydrate provides 50~55% of total dietary energy, protein 10~15%, and fat 20 ~30%. 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%.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yang Tao

References & Publications (14)

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, Fran — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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: 1 — View Citation

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. — View Citation

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. — View Citation

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 Ind — View Citation

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 — View Citation

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. — View Citation

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. Diabetolog — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of time in range (TIR)	TIR represents percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L based on CGMS. TIR changes from 2 weeks to baseline will be compared between the 2 interventions.	Baseline to 2 weeks
Secondary	Change of coefficient of variation of blood glucose(CV)	Reflect glucose fluctuation	Baseline to 2 weeks
Secondary	Change of mean amplitude of glycemic excursions(MAGE)	Reflect glucose fluctuation	Baseline to 2 weeks
Secondary	Change in large amplitude of glycemic excursions (LAGE) from baseline	Reflect glucose fluctuation	Baseline to 2 weeks
Secondary	Change in GA(glycosylated albumin)from baseline	Reflect 2~3 weeks of glycemic control	Baseline to 2 weeks
Secondary	Change in HbA1c from baseline	Reflect 2~3 months of glycemic control	Baseline to 14 weeks
Secondary	Change in 1,5-anhydroglucitol (1,5-AG) from baseline	Reflect 1~2 weeks of glycemic control	Baseline to 2 weeks and to 14 weeks
Secondary	Change in time above range(TAR) from baseline		Baseline to 2 weeks
Secondary	Change in time below range(TBR) from baseline		Baseline to 2 weeks
Secondary	Change in total insulin dose from baseline		Baseline to 2 weeks and to 14 weeks
Secondary	Change in blood lipids from baseline		Baseline to 2 weeks and to 14 weeks
Secondary	Change in body weight from baseline		Baseline to 2 weeks and to 14 weeks
Secondary	Change in Incidence of hypoglycemic events from baseline	Reflects the safety of clinical trials	Baseline to 2 weeks and to 14 weeks
Secondary	Change in gut microbiota from baseline		Baseline to 2 weeks and to 14 weeks
Secondary	Change in metabolomics from baseline		Baseline to 2 weeks and to 14 weeks
Secondary	Change in autoimmunity from baseline		Baseline to 14 weeks