Clinical trial NCT05536232: Residual Insulin Secretion in Patients With Type 1 Diabetes Under a Low Carbohydrate Diet or a Ketogenic Diet
Official title: Residual Insulin Secretion in Patients With Type 1 Diabetes Under a Low Carbohydrate Diet or a Ketogenic Diet
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type1 Diabetes
Keywords: type 1 diabetes
low carbohydrate diet
ketogenic diet
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Peptide C evolution
timeFrame: Day 0 and day 90
Secondary outcomes:
measure: HbA1C measure
timeFrame: Day 0 and day 90
measure: Insulin-dose adjusted A1c (IDAA1C) index calculation
timeFrame: Day 0 and day 90
measure: Weight measure
timeFrame: Day 0 and day 90
measure: Fat mass percentage measure
timeFrame: Day 0 and day 90
measure: Lean mass percentage measure
timeFrame: Day 0 and day 90
measure: Daily dose of insulin
timeFrame: Every day from day 0 to day 90
measure: Circulating rate of Tregs
timeFrame: Day 0 and day 90
measure: Circulating rate of cytokines
timeFrame: Day 0 and day 90
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP - Pitié-Salpêtrière Hospital
Study officials:
References: