Type1 DiabetesKetoDiabNCT05536232
Residual Insulin Secretion in Patients With Type 1 Diabetes Under a Low Carbohydrate Diet or a Ketogenic Diet
A study testing Low carbohydrate diet in people with Type1 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type1 Diabetes
- What is being tested?
- Low carbohydrate diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2022to 13 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Type1 Diabetes
- Being tested
- Low carbohydrate diet
- Keywords
- type 1 diabetes, low carbohydrate diet, ketogenic diet
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low carbohydrate dietBehavioural
Low carbohydrate diet under 75 g per day
| Study group | Role | What they receive |
|---|---|---|
| LCD | Experimental | Not described Receives: Behavioral: Low carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peptide C evolution
Measure of the area under the curve of the peptide C dosage
Measured: Day 0 and day 90
Secondary outcomes (8)
HbA1C measure
Measured: Day 0 and day 90
Insulin-dose adjusted A1c (IDAA1C) index calculation
Measured: Day 0 and day 90
Weight measure
Measured: Day 0 and day 90
Fat mass percentage measure
Measured: Day 0 and day 90
Lean mass percentage measure
Measured: Day 0 and day 90
Daily dose of insulin
Measured: Every day from day 0 to day 90
Circulating rate of Tregs
Measured: Day 0 and day 90
Circulating rate of cytokines
Measured: Day 0 and day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start17 Oct 2022
- Primary completion13 Jan 2026
- Study completion13 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1 DiabetesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536232
- Sponsor's protocol ID
- APHP211325
- Other IDs
- 2022-A00523-40
- Acronym
- KetoDiab
- Status last verified
- Jul 2026
- First submitted
- 7 Sep 2022
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual Insulin Secretion in Patients With Type 1 Diabetes Under a Low Carbohydrate Diet or a Ketogenic Diet
- ClinicalTrials.gov ID
- NCT05536232
- Acronym / sponsor ID
- KetoDiab / APHP211325
- Conditions
- Type1 Diabetes
- Keywords
- type 1 diabetes, low carbohydrate diet, ketogenic diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 13 Jan 2026 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LCD | Experimental | Behavioral: Low carbohydrate diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low carbohydrate dietLow carbohydrate diet under 75 g per day | Behavioural | LCD |
Primary outcome
Peptide C evolution
Time frame: Day 0 and day 90
Measure of the area under the curve of the peptide C dosage
8 secondary outcomes
HbA1C measure
Time frame: Day 0 and day 90
Insulin-dose adjusted A1c (IDAA1C) index calculation
Time frame: Day 0 and day 90
Weight measure
Time frame: Day 0 and day 90
Fat mass percentage measure
Time frame: Day 0 and day 90
Lean mass percentage measure
Time frame: Day 0 and day 90
Daily dose of insulin
Time frame: Every day from day 0 to day 90
Circulating rate of Tregs
Time frame: Day 0 and day 90
Circulating rate of cytokines
Time frame: Day 0 and day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low carbohydrate diet in people with Type1 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peptide C evolution (time frame: Day 0 and day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.