search
Back to results

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

Primary Purpose

Type1 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Low carbohydrate diet
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type1 Diabetes focused on measuring type 1 diabetes, low carbohydrate diet, ketogenic diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, 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

Sites / Locations

  • AP-HP - Pitié-Salpêtrière HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LCD

Arm Description

Outcomes

Primary Outcome Measures

Peptide C evolution
Measure of the area under the curve of the peptide C dosage

Secondary Outcome Measures

HbA1C measure
Insulin-dose adjusted A1c (IDAA1C) index calculation
Weight measure
Fat mass percentage measure
Lean mass percentage measure
Daily dose of insulin
Circulating rate of Tregs
Circulating rate of cytokines

Full Information

First Posted
September 7, 2022
Last Updated
January 19, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
search

1. Study Identification

Unique Protocol Identification Number
NCT05536232
Brief Title
Residual Insulin Secretion in Patients With Type 1 Diabetes Under a Low Carbohydrate Diet or a Ketogenic Diet
Acronym
KetoDiab
Official Title
Residual Insulin Secretion in Patients With Type 1 Diabetes Under a Low Carbohydrate Diet or a Ketogenic Diet
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1 Diabetes
Keywords
type 1 diabetes, low carbohydrate diet, ketogenic diet

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LCD
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Low carbohydrate diet
Intervention Description
Low carbohydrate diet under 75 g per day
Primary Outcome Measure Information:
Title
Peptide C evolution
Description
Measure of the area under the curve of the peptide C dosage
Time Frame
Day 0 and day 90
Secondary Outcome Measure Information:
Title
HbA1C measure
Time Frame
Day 0 and day 90
Title
Insulin-dose adjusted A1c (IDAA1C) index calculation
Time Frame
Day 0 and day 90
Title
Weight measure
Time Frame
Day 0 and day 90
Title
Fat mass percentage measure
Time Frame
Day 0 and day 90
Title
Lean mass percentage measure
Time Frame
Day 0 and day 90
Title
Daily dose of insulin
Time Frame
Every day from day 0 to day 90
Title
Circulating rate of Tregs
Time Frame
Day 0 and day 90
Title
Circulating rate of cytokines
Time Frame
Day 0 and day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chloé Amouyal, MD, PhD
Phone
01 42 16 57 92
Ext
+33
Email
chloe.amouyal@aphp.fr
Facility Information:
Facility Name
AP-HP - Pitié-Salpêtrière Hospital
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chloé Amouyal, MD, PhD
Phone
01 42 16 57 92
Ext
+33
Email
chloe.amouyal@aphp.fr

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs