Type 1 DiabetesNCT04228822
Safety and Feasibility of a Low Carbohydrate Diet in Children With Type 1 Diabetes
A study testing Low carbohydrate diet in people with Type 1 Diabetes, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Good glycemic control in individuals with Type 1 diabetes (T1D), has been proven to reduce the risk of diabetes-related complications. Despite technological advances such as the use of insulin delivery devices and continuous glucose monitoring, the average glycemic control in T1D is poor. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Low carbohydrate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2020to 28 Feb 2022
- 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 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients 5-11 years of age, with history of Type 1 diabetes for longer than 2 years,
- No carbohydrate restrictions at the time of recruitment.
- No medications that could affect appetite
- Regular attendance at the clinic (3-4 times per year),
- Glycated hemoglobin (HbA1c) <10%.
Who cannot join
- Impaired renal or liver function,
- Chronic seizures or global developmental delay,
- Diagnosed with ADHD and/or on ADHD medications
- Use of drugs other than insulin affecting glucose metabolism
- Severe eczema
- Celiac disease
Trial locations and contacts
1 site in 1 country.
United States1 site
St Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Good glycemic control in individuals with Type 1 diabetes (T1D), has been proven to reduce the risk of diabetes-related complications. Despite technological advances such as the use of insulin delivery devices and continuous glucose monitoring, the average glycemic control in T1D is poor. Though dietary management plays a major role in the overall management of T1D, and it is often classified as the most challenging aspect of treatment, the 2019 Standards of Medical Care in Diabetes for children and adolescents do not clearly address dietary management. As carbohydrate is the macronutrient with the greatest impact on blood glucose, it is reasonable to suggest that carbohydrate reduction will minimize postprandial glucose excursions and improve diabetes control. For this reason, low carbohydrate diets (LCD) have gained popularity, and observational studies report positive glycemic outcomes. However, to date, scientific evidence from randomized trials on the impact of LCD in children with T1D is lacking. Thus, the over-arching goal of this pilot study is to evaluate the feasibility and safety of a low carbohydrate diet in children with T1D, and as an exploratory aim, we will evaluate the efficacy of LCD on glycemic control.
Read the detailed description
The investigators aim to study 40 subjects ages 5-11 with T1D to evaluate the feasibility of LCD. Participants will be asked to attend a total of 5 visits (4 in person and 1 phone visit) during the 6 month-duration of the study. Participants will be randomized to an intervention group with a LCD (50% of carbohydrate recommended daily allowance) vs. the standard diet.
During the screening visit, participants will be assessed by a dietitian to categorize their existing dietary regimen before randomization to either the LCD or the standard diet. In addition, participant's insulin regimen (either pump settings or multiple dose insulin injection therapy) will be reviewed for insulin dose adjustments as needed over a 2 week-period.
- Conditions
- Type 1 Diabetes
- Being tested
- Low carbohydrate 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 dietOther
25-35% of carbohydrates from total energy intake
| Study group | Role | What they receive |
|---|---|---|
| Low carb diet intervention group | Experimental | Low carbohydrate diet defined as 25-35% of total energy intake Receives: Other: Low carbohydrate diet |
| Control | No intervention | Standard diet defined as 45-65% total energy intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hypoglycemic events
Using a continuous glucose monitor (CGM) and home glucose meter, investigators will calculate the number of hypoglycemic events (glucose values <70 mg/dL but ≥ 54 mg/dL and those <54 mg/dL), number of severe hypoglycemia and time spent in hypoglycemia (values <70 mg/dL but ≥ 54 mg/dL and <54 mg/dL).
Measured: 6 month study period
Episodes of diabetes related visits to the hospital, DKA
Investigators will obtain data prospectively from medical records and will estimate the frequency of DKA, diabetes related hospitalizations / emergency department visits.
Measured: 6 month study period
Dyslipidemia
Investigators will evaluate the changes in LDL levels among the study groups.
Measured: 6 month study period
Secondary outcomes (2)
Glycemic control
Investigators will evaluate the changes in glycemic control among the groups using HbA1c at baseline, 3 and 6 months.
Measured: 6 month duration of the study
Glucose variability
Using CGM data investigators will evaluate glucose variability using standard deviation (SD) of all glucose values. Secondary endpoints will include time of the day spent in range (values between 70-140 mg/dl and between 70 and 180mg/dl), in hypoglycemia (values <70 mgl/dl but ≥ 54 mg/dl and <54 mg/dl) and in hyperglycemia (values >180mg/dl and >250 mg/dl).
Measured: 6 month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start10 Nov 2020
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 20 participants will be randomized to the intervention group (low carbohydrate diet) and 20 participants will be randomized to the control group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- ICTS BJH, Center for Diabetes Translation Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228822
- Sponsor's protocol ID
- 201911121
- Status last verified
- Mar 2022
- First submitted
- 11 Dec 2019
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of a Low Carbohydrate Diet in Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04228822
- Acronym / sponsor ID
- 201911121
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- ICTS BJH, Center for Diabetes Translation Research
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 14 Jan 2020 (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.
Good glycemic control in individuals with Type 1 diabetes (T1D), has been proven to reduce the risk of diabetes-related complications. Despite technological advances such as the use of insulin delivery devices and continuous glucose monitoring, the average glycemic control in T1D is poor. Though dietary management plays a major role in the overall management of T1D, and it is often classified as the most challenging aspect of treatment, the 2019 Standards of Medical Care in Diabetes for children and adolescents do not clearly address dietary management. As carbohydrate is the macronutrient with the greatest impact on blood glucose, it is reasonable to suggest that carbohydrate reduction will minimize postprandial glucose excursions and improve diabetes control. For this reason, low carbohydrate diets (LCD) have gained popularity, and observational studies report positive glycemic outcomes. However, to date, scientific evidence from randomized trials on the impact of LCD in children with T1D is lacking. Thus, the over-arching goal of this pilot study is to evaluate the feasibility and safety of a low carbohydrate diet in children with T1D, and as an exploratory aim, we will evaluate the efficacy of LCD on glycemic control.
Detailed description
The investigators aim to study 40 subjects ages 5-11 with T1D to evaluate the feasibility of LCD. Participants will be asked to attend a total of 5 visits (4 in person and 1 phone visit) during the 6 month-duration of the study. Participants will be randomized to an intervention group with a LCD (50% of carbohydrate recommended daily allowance) vs. the standard diet.
During the screening visit, participants will be assessed by a dietitian to categorize their existing dietary regimen before randomization to either the LCD or the standard diet. In addition, participant's insulin regimen (either pump settings or multiple dose insulin injection therapy) will be reviewed for insulin dose adjustments as needed over a 2 week-period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 20 participants will be randomized to the intervention group (low carbohydrate diet) and 20 participants will be randomized to the control group
| Arm | Type | Receives |
|---|---|---|
| Low carb diet intervention group | Experimental | Other: Low carbohydrate dietLow carbohydrate diet defined as 25-35% of total energy intake |
| Control | No intervention | –Standard diet defined as 45-65% total energy intake |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients 5-11 years of age, with history of Type 1 diabetes for longer than 2 years,
- No carbohydrate restrictions at the time of recruitment.
- No medications that could affect appetite
- Regular attendance at the clinic (3-4 times per year),
- Glycated hemoglobin (HbA1c) <10%.
Key exclusion criteria (6 listed)
- Impaired renal or liver function,
- Chronic seizures or global developmental delay,
- Diagnosed with ADHD and/or on ADHD medications
- Use of drugs other than insulin affecting glucose metabolism
- Severe eczema
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 diet25-35% of carbohydrates from total energy intake | Other | Low carb diet intervention group |
Primary outcome
Number of hypoglycemic events
Time frame: 6 month study period
Using a continuous glucose monitor (CGM) and home glucose meter, investigators will calculate the number of hypoglycemic events (glucose values <70 mg/dL but ≥ 54 mg/dL and those <54 mg/dL), number of severe hypoglycemia and time spent in hypoglycemia (values <70 mg/dL but ≥ 54 mg/dL and <54 mg/dL).
Episodes of diabetes related visits to the hospital, DKA
Time frame: 6 month study period
Investigators will obtain data prospectively from medical records and will estimate the frequency of DKA, diabetes related hospitalizations / emergency department visits.
Dyslipidemia
Time frame: 6 month study period
Investigators will evaluate the changes in LDL levels among the study groups.
2 secondary outcomes
Glycemic control
Time frame: 6 month duration of the study
Glucose variability
Time frame: 6 month study period
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 9 Mar 2022.
- Individual participant dataSharing planned: No
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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 Type 1 Diabetes, run by Washington University School of Medicine at 1 site in United States.
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 6 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 9 Mar 2022. 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 United States. 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?
Number of hypoglycemic events (time frame: 6 month study period). The study lists 3 primary outcomes in all. 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 9 Mar 2022.