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Completed

NCT Number: NCT05536232

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

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.

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Key information

Conditions

Type1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AP-HP - Pitié-Salpêtrière Hospital

Paris, 75013, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

low carbohydrate diet

Behavioral

Low carbohydrate diet under 75 g per day

Primary outcomes

  1. Peptide C evolution

    Time frame: Day 0 and day 90

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

Secondary outcomes

  1. HbA1C measure

    Time frame: Day 0 and day 90

  2. Insulin-dose adjusted A1c (IDAA1C) index calculation

    Time frame: Day 0 and day 90

  3. Weight measure

    Time frame: Day 0 and day 90

  4. Fat mass percentage measure

    Time frame: Day 0 and day 90

  5. Lean mass percentage measure

    Time frame: Day 0 and day 90

  6. Daily dose of insulin

    Time frame: Every day from day 0 to day 90

  7. Circulating rate of Tregs

    Time frame: Day 0 and day 90

  8. Circulating rate of cytokines

    Time frame: Day 0 and day 90

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: KetoDiab

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2022
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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