Residual Insulin Secretion in Patients With Type 1 Diabetes Under a Low Carbohydrate Diet or a Ketogenic Diet

Not Applicable

Recruiting

• Conditions: Type1 Diabetes
• Interventions: Behavioral: Low carbohydrate diet

• Registration Number: NCT05536232
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-10
• Study Start: 2022-10-17
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-20
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LCD	Low carbohydrate diet	-

Primary Outcome Measures

Name	Time	Method
Peptide C evolution	Day 0 and day 90	Measure of the area under the curve of the peptide C dosage

Secondary Outcome Measures

Name	Time	Method
Weight measure	Day 0 and day 90
Lean mass percentage measure	Day 0 and day 90
HbA1C measure	Day 0 and day 90
Fat mass percentage measure	Day 0 and day 90
Insulin-dose adjusted A1c (IDAA1C) index calculation	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

Trial Locations

Locations (1)

AP-HP - Pitié-Salpêtrière Hospital; 🇫🇷 Paris, France