Trials / Unknown
UnknownNCT05536232
Residual Insulin Secretion in Patients With Type 1 Diabetes Under a Low Carbohydrate Diet or a Ketogenic Diet
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Low carbohydrate diet | Low carbohydrate diet under 75 g per day |
Timeline
- Start date
- 2022-10-17
- Primary completion
- 2024-09-01
- Completion
- 2024-09-01
- First posted
- 2022-09-10
- Last updated
- 2023-01-20
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05536232. Inclusion in this directory is not an endorsement.