Type 1 Diabetes MellitusNCT03862521
Safety of Low and Very Low Carbohydrate Diets in Young Children With Type 1 Diabetes
A study testing Low carbohydrate diet and Very low carbohydrate diet in people with Type 1 Diabetes Mellitus and Diet Modification, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the safety of short-term (6 month) low or very-low carbohydrate diets in prepubertal children 2 to <12 years old with type 1 diabetes. Participants will be randomized to either low carbohydrate diet (carbohydrate makes up 30-39% of total daily calories) or very-low carbohydrate… Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Diet Modification, Child, Only
- What is being tested?
- Low carbohydrate diet and Very low carbohydrate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 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 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Prepubertal children 2 to <12 years old (i.e., before 12th birthday)
- Type 1 diabetes for at least 6 months
- Patients must be using insulin pump therapy
- Not presently on low carbohydrate diet
Who cannot join
- On low or very low carbohydrate diet
- History of endocrine or metabolic disorder that could affect counter-regulation (well-controlled hypothyroidism is acceptable if on stable dose of l-thyroxine for ≥3 months)
- History of metabolic disorder affection lipid metabolism
- Severe hypoglycemic event in past 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Clinic
Jacksonville, Florida, 32207
About this study
The purpose of the study is to evaluate the safety of short-term (6 month) low or very-low carbohydrate diets in prepubertal children 2 to <12 years old with type 1 diabetes. Participants will be randomized to either low carbohydrate diet (carbohydrate makes up 30-39% of total daily calories) or very-low carbohydrate diet (carbohydrates are 20-29% of total daily calories). The investigators will evaluate metabolic effects of these diets by measuring the counter-regulatory hormone response to hypoglycemia at baseline and again at 3 months. Other outcomes include diabetes control as measured by HbA1c, growth and weight gain, lipid profiles, and body composition.
Read the detailed description
The purpose of the study is to evaluate the safety of short-term (6 month) low or very-low carbohydrate diets in prepubertal children 2 to <12 years old with type 1 diabetes. Participants will be randomized to either low carbohydrate diet (carbohydrate makes up 30-39% of total daily calories) or very-low carbohydrate diet (carbohydrates are 20-29% of total daily calories). The investigators will evaluate metabolic effects of these diets by measuring the counter-regulatory hormone response to hypoglycemia at baseline and again at 3 months. Other outcomes include diabetes control as measured by HbA1c, growth and weight gain, lipid profiles, and body composition.
Participants will be admitted to the Clinical Research Center at baseline and 3 months. Gradual reduction in serum glucose to under 80 mg/dL will be achieved by an increase in their insulin infusion rate through their insulin pump. Plasma glucose, catecholamines (epinephrine, norepinephrine), glucagon, and serum ketones are measured at baseline and after glucose is below 80 mg/dL. All subjects will have lipid evaluation and body composition (DXA scan) at baseline and 6 months. Subjects' growth will be evaluated by comparing their height and weight z-score before and after the 6 months of diet intervention. Change in growth velocity will also be assessed. During the study, participants not already using continuous glucose monitoring will be placed on Dexcom G5 to monitor blood sugars regularly. Subjects will also be monitoring serum ketones at home regularly.
- Conditions
- Type 1 Diabetes Mellitus, Diet Modification, Child, Only
- Being tested
- Low carbohydrate diet, Very low carbohydrate diet
- Keywords
- type 1 diabetes, low carbohydrate diets, insulin pump therapy, continuous glucose monitoring
- 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
Low carbohydrate diet
Very low carbohydrate dietOther
Very low carbohydrate diet
| Study group | Role | What they receive |
|---|---|---|
| Low carbohydrate diet group | Experimental | Low carb diet, carbohydrates make up 30-40% of total daily calories. Receives: Other: Low carbohydrate diet |
| Very low carbohydrate diet | Experimental | Very low carb diet, carbohydrates make up 20-29% of total daily calories. Receives: Other: Very low carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hormone (epinephrine, norepinephrine, glucagon) response to hypoglycemia
Change from baseline to 3 months in the hormone (epinephrine, norepinephrine, glucagon) response to insulin-induced hypoglycemia.
Measured: Baseline to 3 months
Secondary outcomes (5)
Change in height in centimeters from baseline to 6 months
Change in height in centimeters from baseline to 6 months
Measured: Baseline to 6 months
Change in weight in kilograms from baseline to 6 months
Change in weight in kilograms from baseline to 6 months
Measured: Baseline to 6 months
Change in body composition from baseline to 6 months
Change in percent body fat using DXA scan from baseline to 6 months
Measured: Baseline to 6 months
Change in A1c from baseline to 3 and 6 months
Change in A1c over the length of the study
Measured: Change from baseline to 3 and 6 months
Change in lipid profile from baseline to 6 months
Change in lipid profile from baseline to 6 months
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Aug 2018
- 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 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized to either low or very low carbohydrate diet
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Larry A Fox, MD, Principal investigator, Nemours Children's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862521
- Sponsor's protocol ID
- LowCHOT1D
- Status last verified
- May 2022
- First submitted
- 26 Feb 2019
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Low and Very Low Carbohydrate Diets in Young Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03862521
- Acronym / sponsor ID
- LowCHOT1D
- Conditions
- Type 1 Diabetes Mellitus, Diet Modification, Child, Only
- Keywords
- type 1 diabetes, low carbohydrate diets, insulin pump therapy, continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 5 Mar 2019 (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.
The purpose of the study is to evaluate the safety of short-term (6 month) low or very-low carbohydrate diets in prepubertal children 2 to <12 years old with type 1 diabetes. Participants will be randomized to either low carbohydrate diet (carbohydrate makes up 30-39% of total daily calories) or very-low carbohydrate diet (carbohydrates are 20-29% of total daily calories). The investigators will evaluate metabolic effects of these diets by measuring the counter-regulatory hormone response to hypoglycemia at baseline and again at 3 months. Other outcomes include diabetes control as measured by HbA1c, growth and weight gain, lipid profiles, and body composition.
Detailed description
The purpose of the study is to evaluate the safety of short-term (6 month) low or very-low carbohydrate diets in prepubertal children 2 to <12 years old with type 1 diabetes. Participants will be randomized to either low carbohydrate diet (carbohydrate makes up 30-39% of total daily calories) or very-low carbohydrate diet (carbohydrates are 20-29% of total daily calories). The investigators will evaluate metabolic effects of these diets by measuring the counter-regulatory hormone response to hypoglycemia at baseline and again at 3 months. Other outcomes include diabetes control as measured by HbA1c, growth and weight gain, lipid profiles, and body composition.
Participants will be admitted to the Clinical Research Center at baseline and 3 months. Gradual reduction in serum glucose to under 80 mg/dL will be achieved by an increase in their insulin infusion rate through their insulin pump. Plasma glucose, catecholamines (epinephrine, norepinephrine), glucagon, and serum ketones are measured at baseline and after glucose is below 80 mg/dL. All subjects will have lipid evaluation and body composition (DXA scan) at baseline and 6 months. Subjects' growth will be evaluated by comparing their height and weight z-score before and after the 6 months of diet intervention. Change in growth velocity will also be assessed. During the study, participants not already using continuous glucose monitoring will be placed on Dexcom G5 to monitor blood sugars regularly. Subjects will also be monitoring serum ketones at home regularly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized to either low or very low carbohydrate diet
| Arm | Type | Receives |
|---|---|---|
| Low carbohydrate diet group | Experimental | Other: Low carbohydrate dietLow carb diet, carbohydrates make up 30-40% of total daily calories. |
| Very low carbohydrate diet | Experimental | Other: Very low carbohydrate dietVery low carb diet, carbohydrates make up 20-29% of total daily calories. |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Prepubertal children 2 to <12 years old (i.e., before 12th birthday)
- Type 1 diabetes for at least 6 months
- Patients must be using insulin pump therapy
- Not presently on low carbohydrate diet
Key exclusion criteria (4 listed)
- On low or very low carbohydrate diet
- History of endocrine or metabolic disorder that could affect counter-regulation (well-controlled hypothyroidism is acceptable if on stable dose of l-thyroxine for ≥3 months)
- History of metabolic disorder affection lipid metabolism
- Severe hypoglycemic event in past 3 months
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 | Other | Low carbohydrate diet group |
| Very low carbohydrate dietVery low carbohydrate diet | Other | Very low carbohydrate diet |
Primary outcome
Change in hormone (epinephrine, norepinephrine, glucagon) response to hypoglycemia
Time frame: Baseline to 3 months
Change from baseline to 3 months in the hormone (epinephrine, norepinephrine, glucagon) response to insulin-induced hypoglycemia.
5 secondary outcomes
Change in height in centimeters from baseline to 6 months
Time frame: Baseline to 6 months
Change in weight in kilograms from baseline to 6 months
Time frame: Baseline to 6 months
Change in body composition from baseline to 6 months
Time frame: Baseline to 6 months
Change in A1c from baseline to 3 and 6 months
Time frame: Change from baseline to 3 and 6 months
Change in lipid profile from baseline to 6 months
Time frame: Baseline to 6 months
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 25 May 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.
Larry A Fox, MD principal investigator
Nemours Children's Health
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 and Very low carbohydrate diet in people with Type 1 Diabetes Mellitus and Diet Modification, run by Nemours Children's Clinic 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 4 inclusion and 4 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 25 May 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?
Change in hormone (epinephrine, norepinephrine, glucagon) response to hypoglycemia (time frame: Baseline to 3 months). 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 25 May 2022.