Type 1 DiabetesNCT06273631
Effect of Different Carbohydrate Intake Patterns on Glycemic Control in Patients With Type 1 Diabetes
A study testing diverse carbohydrate diet and moderate carbohydrate diet in people with Type 1 Diabetes and Diet Intervention, run by Yang Tao at 1 site in China.
Trial summary
This multicenter, randomized, controlled, open-label clinical trial aims to evaluate the effects of different carbohydrate intake patterns on glycemic control in adults with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes, Diet Intervention, Glucose Control
- What is being tested?
- diverse carbohydrate diet and moderate carbohydrate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who agree to participate in the study and provide written informed consent;
- Diagnosed with type 1 diabetes mellitus according to the ADA 2024 criteria;
- Aged 18 to 70 years, inclusive;
- Receiving exogenous insulin therapy with a stable treatment regimen for at least 2 months before enrollment (the type of insulin should remain unchanged, while the dose may be adjusted according to blood glucose levels);
- Body mass index (BMI) between 18.0 and 25.0 kg/m², inclusive;
- Glycated hemoglobin A1c (HbA1c) <11%.
Who cannot join
- Type 1 diabetes mellitus in the honeymoon phase;
- Pregnant or breastfeeding women, or women for whom pregnancy cannot be ruled out;
- Patients who are vegetarians or are undergoing weight loss;
- Patients who are users of oral hypoglycemic drugs (alpha-glucosidase inhibitors, DPP-4 inhibitors, etc.);
- Use of glucocorticoids within 30 days before enrollment;
- History of severe food allergy;
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- Patients with acute complications such as diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) within the previous 6 months;
- Patients with gastroparesis, inflammatory bowel disease or other complications;
- Patients with macroalbuminuria (albumin-to-creatinine ratio > 34 mg/mmol) or renal insufficiency (creatinine > 200 μmol/L);
- Patients with uncontrolled hyperthyroidism or hypothyroidism (Uncontrolled hyperthyroidism is defined as abnormal TSH and FT4. Uncontrolled hypothyroidism is defined as TSH > 10 mIU/L.);
- History of heart disease, coronary artery disease or arrhythmia;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal;
- History of malignant tumors; history of tumors or surgery affecting digestion or nutrient absorption. Eligibility of participants with a history of benign tumors will be determined by the investigator;
- Patients with other uncontrolled immune system diseases or uncontrolled infections;
- Alcohol abuse, drug abuse, mental disorders, or other conditions unsuitable for study participation;
- Any disease or condition that, in the investigator's judgment, may interfere with study participation or evaluation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210029
Tao Yang, PhD, 86-25-83718836 ext. 6466, yangt@njmu.edu.cn
About this study
This multicenter, randomized, controlled, open-label clinical trial aims to evaluate the effects of different carbohydrate intake patterns on glycemic control in adults with type 1 diabetes.
Participants will first complete a 2-week run-in period and will then be randomly assigned in a 1:1 ratio to one of two dietary groups. Both diets provide similar proportions of total energy from carbohydrates, protein, and fat, but differ in the sources of staple carbohydrates. In the moderate carbohydrate diet group, most staple foods are refined grains, whereas in the diverse carbohydrate diet group, approximately half of the staple foods are whole grains and legumes.
80 participants will follow the assigned dietary intervention for 2 weeks, followed by a 12-week follow-up period. The primary outcome is time in range (TIR), defined as the percentage of time that glucose levels are within the target range, measured using continuous glucose monitoring. Other measures of glycemic control, glycemic variability, insulin requirements, body measurements, metabolic indicators, and safety will also be evaluated. Exploratory analyses will assess potential changes in gut microbiota, immune function, and metabolomic profiles.
Read the detailed description
Medical nutrition therapy is an important component of the management of type 1 diabetes. In addition to the amount of carbohydrate consumed, the source and quality of dietary carbohydrates may influence glycemic responses and glycemic variability. However, evidence regarding the effects of different carbohydrate intake patterns in people with type 1 diabetes remains limited, particularly when glycemic outcomes are assessed using continuous glucose monitoring.
This study is designed to compare two dietary patterns that provide comparable total energy intake and the same target macronutrient distribution but differ in the sources of staple carbohydrates. Individual energy intake is determined according to each participant's estimated energy requirement. In both groups, carbohydrates provide 45%-55% of total energy, protein provides 15%-20%, and fat provides 25%-35%.
In the moderate carbohydrate diet (MCD) group, 90%-95% of staple foods are derived from refined grains. In the diverse carbohydrate diet (DCD) group, 45%-50% of staple foods are derived from refined grains and 45%-50% from whole grains and legumes. Thus, the principal difference between the two dietary patterns is the source and diversity of staple carbohydrates rather than total energy intake or overall macronutrient composition.
By minimizing differences in total energy intake and macronutrient distribution between the two groups, this study aims to evaluate whether changing the sources and diversity of dietary carbohydrates influences glycemic control and glycemic variability in people with type 1 diabetes.
In addition to clinical and metabolic assessments, exploratory analyses will evaluate changes in gut microbiota, immune function, and metabolomics to investigate potential mechanisms through which different carbohydrate intake patterns may affect glycemic control.
- Conditions
- Type 1 Diabetes, Diet Intervention, Glucose Control
- Being tested
- diverse carbohydrate diet, moderate carbohydrate diet
- Keywords
- dietary fiber, autoimmunity, metabolomics, intestinal microbiota, time in range
- Medical subject headings
- Diabetes Mellitus, Type 1, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diverse carbohydrate dietOther
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%.
moderate carbohydrate dietOther
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%.
| Study group | Role | What they receive |
|---|---|---|
| diverse carbohydrate diet | Experimental | 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%. Receives: Other: diverse carbohydrate diet |
| moderate carbohydrate diet | Other | 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%. Receives: Other: moderate carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range (TIR)
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.
Measured: 4 weeks (2 weeks after randomization)
Secondary outcomes (27)
Time above range(TAR)
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.
Measured: 4 weeks (2 weeks after randomization)
Time below range(TBR)
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.
Measured: 4 weeks (2 weeks after randomization)
Mean glucose (MG)
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.
Measured: 4 weeks (2 weeks after randomization)
Standard deviation of glucose (SD)
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.
Measured: 4 weeks (2 weeks after randomization)
Glucose coefficient of variation (CV)
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.
Measured: 4 weeks (2 weeks after randomization)
Mean amplitude of glycemic excursions (MAGE)
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.
Measured: 4 weeks (2 weeks after randomization)
Largest amplitude of glycemic excursions (LAGE)
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.
Measured: 4 weeks (2 weeks after randomization)
Glycated albumin (GA)
Glycated albumin will be measured at the end of the 2-week dietary intervention and compared between the two groups.
Measured: 4 weeks (2 weeks after randomization)
Glycated hemoglobin A1c (HbA1c)
HbA1c will be measured at the end of the follow-up period and compared between the two groups.
Measured: 16 weeks (14 weeks after randomization)
C-peptide area under the curve (AUC C-peptide)
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.
Measured: 16 weeks (14 weeks after randomization)
Glucagon area under the curve (AUC glucagon)
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.
Measured: 16 weeks (14 weeks after randomization)
Fasting blood glucose (FBG)
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.
Measured: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Total cholesterol (TC)
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.
Measured: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Triglycerides (TG)
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.
Measured: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Low-density lipoprotein cholesterol (LDL-C)
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.
Measured: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
High-density lipoprotein cholesterol (HDL-C)
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.
Measured: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
1,5-Anhydroglucitol (1,5-AG)
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.
Measured: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Total daily insulin dose
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.
Measured: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Basal insulin dose
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.
Measured: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Prandial insulin dose
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.
Measured: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Body weight
Body weight will be measured at the end of the dietary intervention and at the end of the follow-up period.
Measured: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Waist circumference
Waist circumference will be measured at the end of the dietary intervention and at the end of the follow-up period.
Measured: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Hip circumference
Hip circumference will be measured at the end of the dietary intervention and at the end of the follow-up period.
Measured: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Waist-to-hip ratio (WHR)
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.
Measured: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Body composition
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.
Measured: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Hypoglycemic events
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.
Measured: From randomization to the end of follow-up at 16 weeks
Diabetic ketoacidosis (DKA)
The number and proportion of participants experiencing diabetic ketoacidosis will be assessed and compared between the two groups.
Measured: From randomization to the end of follow-up at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start1 Aug 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yang Tao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yang Tao, Nanjing Medical University
- Investigators
- Tao Yang, MD/PhD, Principal investigator, First Affiliated Hospital, Nanjing Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273631
- Sponsor's protocol ID
- 2022-SR-481.A3
- Status last verified
- Sep 2026
- First submitted
- 23 Feb 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34836409Clark 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.
PubMed 34212475Lejk 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.
PubMed 34836071Thewjitcharoen 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.
PubMed 34513096Seidelmann 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.
PubMed 30122560Jaacks 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.
PubMed 25630525Hollowell 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.
PubMed 11836274Zhai 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.
PubMed 30351201Barouti 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.
PubMed 37513510Wong 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.
PubMed 33039330Buehler 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.
PubMed 34598919Smart 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.
PubMed 24170749Leow 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.
PubMed 29737587Vetrani 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.
PubMed 34689215Berry 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.
PubMed 32528151