NCT05536232Completed
Residual Insulin Secretion in Patients With Type 1 Diabetes Under a Low Carbohydrate Diet or a Ketogenic Diet
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 7 Sept 2022
- Start date
- 17 Oct 2022
- Primary completion date
- 13 Jan 2026
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Type 1 diabetes
- NCT number
- NCT05536232
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 17 Oct 2022 to the primary completion date, 13 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- history of ketoacidosis within the last 5 years, except during diabetes diagnosis
- autoimmune disease, except thyroiditis
- 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
Other
- already on a low carbohydrate diet of less than 100 g per day
- immunosuppressive 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AP-HP - Pitié-Salpêtrière Hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.