Type1 Diabetes
Conditions
Keywords
type 1 diabetes, low carbohydrate diet, ketogenic diet
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.
Interventions
BEHAVIORALLow carbohydrate diet
Low carbohydrate diet under 75 g per day
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peptide C evolution | Day 0 and day 90 | Measure of the area under the curve of the peptide C dosage |
Secondary
| Measure | Time frame |
|---|---|
| HbA1C measure | Day 0 and day 90 |
| Insulin-dose adjusted A1c (IDAA1C) index calculation | Day 0 and day 90 |
| Weight measure | Day 0 and day 90 |
| Fat mass percentage measure | Day 0 and day 90 |
| Lean mass percentage measure | Day 0 and day 90 |
| Daily dose of insulin | Every day from day 0 to day 90 |
| Circulating rate of Tregs | Day 0 and day 90 |
| Circulating rate of cytokines | Day 0 and day 90 |
Countries
France
Outcome results
None listed