Residual Insulin Secretion in Patients With Type 1 Diabetes Under a Low Carbohydrate Diet or a Ke… (NCT05536232) | Clinical Trial Compass
CompletedNot Applicable
Residual Insulin Secretion in Patients With Type 1 Diabetes Under a Low Carbohydrate Diet or a Ketogenic Diet
France30 participantsStarted 2022-10-17
Plain-language summary
Low Carbohydrate Diet (LCD) (\< 130 g of carbohydrate per day) and ketogenic diet (\< 50 g of carbohydrate per day) are popular among patients with type 1 diabetes (T1D). In most cases, LCD allow a better glycemic control and a important decrease of insulin requirements that cannot, however, be the sole result of low carbohydrate intake. However, due to the increase production of ketone bodies and the decrease of the insulin/glucagon rate, this diet is not without risk in T1D patients and some of them develop ketoacidosis.
Type 1 diabetes is a autoimmune disease defined by the destruction of the pancreatic beta cells by the effector T cells, in condition of low regulatory T cells (Tregs). Indeed, some nutrients could regulate the plasticity and the function of Tregs, and be involved in the control of some autoimmune diseases in animals models thanks to a direct effect on immune cells of the digestive tract or an indirect effect by microbiota modulation.
The study hypothesises that LCD may be able to restore residual insulin secretion in some patients by modulating immunity. The metabolic mechanisms leading to the effects described in patients with T1D patients under LCD have not been studied : in particular, there is no data on the evolution of the residual insulin secretion and no immunological parameter has been studied on these patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years old or older
* type 1 diabetes for less than 20 years
* willing to start a low carbohydrate diet of less than 75 g per day
* under continuous glucose monitoring
* having been informed about the study and having given their written and informed consent
Exclusion Criteria:
* already on a low carbohydrate diet of less than 100 g per day
* history of ketoacidosis within the last 5 years, except during diabetes diagnosis
* autoimmune disease, except thyroiditis
* immunosuppressive treatment
* hepatitis B virus, hepatitis C virus or human immunodeficiency virus infection
* ongoing cancer or history of cancer within the past 5 years, except in situ cervical cancer or basal cell cancer with early treatment
* participation to another interventional study within the past 3 months
* pregnancy or breast feeding
* no affiliation to a social security scheme
* patients subject to legal protection measures
* unability to give consent for the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at how a low-carbohydrate or ketogenic diet affects residual insulin secretion in type 1 diabetes — measured by C-peptide levels — so could you explain what my current C-peptide level is and whether preserving any remaining insulin secretion is a realistic goal for me?
2Since this study has already completed, has the data been published yet, and if so, what did it actually show about whether these diets helped maintain beta cell function in people with type 1 diabetes?
3A ketogenic or very low-carb diet is a significant lifestyle change for someone managing type 1 diabetes — what risks, like hypoglycemia or diabetic ketoacidosis, would I need to watch out for if we considered trying something similar in my own care?
4Because this was a non-interventional or observational-style study (Phase NA), does it tell us enough about safety and effectiveness for you to feel comfortable guiding me toward a low-carb approach, or would you want to see more evidence first?
5Before considering a diet like the one studied here, are there standard diabetes management strategies I should try first, or is adjusting my carbohydrate intake something that could realistically be layered on top of my current treatment plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.