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

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.

Study Overview

• Status: Recruiting
• Conditions: Type1 Diabetes
• Intervention / Treatment: Behavioral: Low carbohydrate diet

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chloé Amouyal, MD, PhD; Phone Number: +33 01 42 16 57 92; Email: chloe.amouyal@aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • AP-HP - Pitié-Salpêtrière Hospital
    • Contact: Chloé Amouyal, MD, PhD; Phone Number: +33 01 42 16 57 92; Email: chloe.amouyal@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LCD	Behavioral: Low carbohydrate diet; Low carbohydrate diet under 75 g per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peptide C evolution	Measure of the area under the curve of the peptide C dosage	Day 0 and day 90

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: ketogenic diet; type 1 diabetes; low carbohydrate diet
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: APHP211325; 2022-A00523-40 (Registry Identifier: DRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No