NCT05536232

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 17, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

January 20, 2023

Status Verified

June 1, 2022

Enrollment Period

1.9 years

First QC Date

September 7, 2022

Last Update Submit

January 19, 2023

Conditions

Type1 Diabetes

Keywords

type 1 diabeteslow carbohydrate dietketogenic diet

Outcome Measures

Primary Outcomes (1)

  • Peptide C evolution

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

    Day 0 and day 90

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (1)

LCD

EXPERIMENTAL
Behavioral: Low carbohydrate diet

Interventions

Low carbohydrate dietBEHAVIORAL

Low carbohydrate diet under 75 g per day

LCD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP - Pitié-Salpêtrière Hospital

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Central Study Contacts

Chloé Amouyal, MD, PhD

CONTACT

01 42 16 57 92chloe.amouyal@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2022

First Posted

September 10, 2022

Study Start

October 17, 2022

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

January 20, 2023

Record last verified: 2022-06

Locations

FR(1)