Type 1 DiabetesNCT04082884
Very Low Carbohydrate Diet as an Adjunctive Therapy for Youth Type 1 Diabetes
A study testing Very Low Carbohydrate Diet in people with Type 1 Diabetes, run by Yale University at 1 site in United States.
Trial summary
This prospective, open-label pilot/feasibility study of 10 youth with T1D is to evaluate glycemic and metabolic changes taking place with a very low carbohydrate diet. Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Very Low Carbohydrate Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2020to 20 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- BMI 19-30 m2 for individuals at least 18 years old or BMI < 95 percentile for individuals less than 18 years old
- Participants 18 years of age must be able to read and provide written consent
- Participants under 18 years of age must be able to read and provide written assent
- Participants are managed using an insulin pump or injections
- Participant has or is willing to wear a CGM for the duration of the study
- Participant is willing to complete diet logging procedures stated above
Who cannot join
- A1c < 6.5% or > 10%
- Recent history of more than 1 of diabetic ketoacidosis (DKA) in the past 6 months
- Treatment with glucose-lowering drugs other than insulin
- Unstable psychiatric disorders, including eating disorders (DSM-V criteria)
- Weight loss medications within the last 6 months
- Females who are pregnant, lactating or planning to become pregnant in the next 6 months
- Another medical condition that precludes participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale-New Haven Hospital
New Haven, Connecticut, 06511
About this study
This prospective, open-label pilot/feasibility study of 10 youth with T1D is to evaluate glycemic and metabolic changes taking place with a very low carbohydrate diet.
Read the detailed description
First, to evaluate the feasibility of following each type of VLCD (high protein or high fat), participants will follow a standard carbohydrate diet for 2 weeks, followed by a 1 week transition to a VLCD, and then follow the a high protein VLCD for 2 weeks followed by a high fat VLCD for 2 weeks. The study will consist of 4 in person or virtual visits which will take place over ~7 weeks. All participants will be initially studied for 2 weeks while ingesting a standard diet recommended by the American Diabetes Association, followed by a 1-week transition to a VLCD, and followed by 2 weeks on each type of VLCD (high protein, high fat). During the first (baseline) period fasting β-hydroxybutyrate levels will be measured 2-3 times per week. During the VLCD study periods, fasting β-hydroxybutyrate levels will be measured daily in the morning using a blood ketone meter; insulin doses will be collected using insulin pump downloads and continuous glucose monitoring (CGM) profiles will be used to assess glycemic excursions on each diet, as well as the time in hypo-, eu- and hyperglycemic ranges. The purpose of this study is to examine changes in sensor glucose levels, basal and bolus insulin doses, and metabolic factors following implementation of a very low carbohydrate diet (VLCD). Sensor-derived time glucose ranges will serve as a surrogate marker of hemoglobin A1c given the short duration of the study. Safety measures of the diet will also be assessed, including daily fasting ketone levels.
The first hypothesis of the study is that use of a VLCD with strict monitoring of ketosis will reduce glycemic variability and increase time in target range, defined as 70-180 mg/dL by reducing the time in the hyperglycemic (>180 mg/dL) and hypoglycemic ranges (<70 mg/dL). Decreased carbohydrate intake will lead to less postprandial hyperglycemia. Lower insulin doses for meals and snacks as a result of decreased carbohydrate intake will lessen postprandial hypoglycemia as well.
- Conditions
- Type 1 Diabetes
- Being tested
- Very Low Carbohydrate Diet
- Keywords
- very 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.
Very Low Carbohydrate DietBehavioural
A very low carbohydrate diet (VLCD), is defined as limiting carbohydrate intake to 11% of total daily caloric intake.
| Study group | Role | What they receive |
|---|---|---|
| Very Low Carbohydrate Diet | Experimental | Participants will follow a high protein very low carbohydrate diet (VLCD) for 2 weeks. This will be 11% of caloric intake from carbohydrates, 54% of calories from protein, and 35% of calories from fat. Immediately following this, participants will follow a high protein very low carbohydrate diet (VLCD) which will be 11% of caloric intake from carbohydrates, 23% of calories from protein, and 66% of calories from fat. Receives: Behavioral: Very Low Carbohydrate Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Time in Target Range of 70-180 mg/dL.
The target range is 70 mg/dL - 180 mg/dL based on sensor-derived glucose levels. The outcome is reflected as the percentage of time spent in this range during the time frame.
Measured: 2 weeks per intervention, up to 7 weeks
Secondary outcomes (6)
Percentage of Time Spent > 180 mg/dL to 250 mg/dl
The percent of time spent > 180 mg/dL to 250 mg/dl based on sensor-derived glucose values. Reflected is the percentage of time spent in the range of 181-250 mg/dL.
Measured: 2 weeks per intervention, up to 7 weeks
Percent Time Spent > 250 mg/dL Based on Sensor-derived Glucose Values
The percent of time spent > 250 mg/dL based on sensor-derived glucose values. Presented is the percentage of time people spent in the range.
Measured: 2 weeks per intervention, up to 7 weeks
Percent of Time Spent > = 55 to < 70 mg/dL Based on Sensor-derived Glucose Values
The percent of time spent > = 55 to < 70 mg/dL based on sensor-derived glucose values. Reflected is the percentage of time within range.
Measured: 2 weeks per intervention, up to 7 weeks
Percent Time Spent < 55 mg/dL Based on Sensor-derived Glucose Values
The percent of time spent < 55 mg/dL based on sensor-derived glucose values during the timeframe. Presented is the percentage of overall time spent in the specified range.
Measured: 2 weeks per intervention, up to 7 weeks
Total Daily Insulin Dose
The total daily insulin dose will be defined as the average total daily insulin dose will be calculated over 2 weeks. Values represent the mean units/kg/day for the 2 week period.
Measured: 2 weeks per intervention, up to 7 weeks
Average Sensor Glucose Level
The average sensor glucose level recorded by the continuous glucose monitor over the 2 week dietary period in mg/dL.
Measured: 2 weeks per intervention, up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start25 Jun 2020
- Primary completion20 Feb 2022
- Study completion20 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Following enrollment, participants will follow a standard carbohydrate diet for 2 weeks. They will then undergo a 1 week transition followed by 2 weeks on a higher protein very low carbohydrate diet that is then followed by 2 weeks on a higher fat very low carbohydrate diet.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082884
- Sponsor's protocol ID
- 2000026189
- Other IDs
- 2K12DK094714-06
- Status last verified
- Feb 2024
- First submitted
- 6 Sep 2019
- Last updated
- 15 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Very Low Carbohydrate Diet as an Adjunctive Therapy for Youth Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04082884
- Acronym / sponsor ID
- 2000026189
- Conditions
- Type 1 Diabetes
- Keywords
- very low carbohydrate diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 20 Feb 2022 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Posted 5 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, open-label pilot/feasibility study of 10 youth with T1D is to evaluate glycemic and metabolic changes taking place with a very low carbohydrate diet.
Detailed description
First, to evaluate the feasibility of following each type of VLCD (high protein or high fat), participants will follow a standard carbohydrate diet for 2 weeks, followed by a 1 week transition to a VLCD, and then follow the a high protein VLCD for 2 weeks followed by a high fat VLCD for 2 weeks. The study will consist of 4 in person or virtual visits which will take place over ~7 weeks. All participants will be initially studied for 2 weeks while ingesting a standard diet recommended by the American Diabetes Association, followed by a 1-week transition to a VLCD, and followed by 2 weeks on each type of VLCD (high protein, high fat). During the first (baseline) period fasting β-hydroxybutyrate levels will be measured 2-3 times per week. During the VLCD study periods, fasting β-hydroxybutyrate levels will be measured daily in the morning using a blood ketone meter; insulin doses will be collected using insulin pump downloads and continuous glucose monitoring (CGM) profiles will be used to assess glycemic excursions on each diet, as well as the time in hypo-, eu- and hyperglycemic ranges. The purpose of this study is to examine changes in sensor glucose levels, basal and bolus insulin doses, and metabolic factors following implementation of a very low carbohydrate diet (VLCD). Sensor-derived time glucose ranges will serve as a surrogate marker of hemoglobin A1c given the short duration of the study. Safety measures of the diet will also be assessed, including daily fasting ketone levels.
The first hypothesis of the study is that use of a VLCD with strict monitoring of ketosis will reduce glycemic variability and increase time in target range, defined as 70-180 mg/dL by reducing the time in the hyperglycemic (>180 mg/dL) and hypoglycemic ranges (<70 mg/dL). Decreased carbohydrate intake will lead to less postprandial hyperglycemia. Lower insulin doses for meals and snacks as a result of decreased carbohydrate intake will lessen postprandial hypoglycemia as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Following enrollment, participants will follow a standard carbohydrate diet for 2 weeks. They will then undergo a 1 week transition followed by 2 weeks on a higher protein very low carbohydrate diet that is then followed by 2 weeks on a higher fat very low carbohydrate diet.
| Arm | Type | Receives |
|---|---|---|
| Very Low Carbohydrate Diet | Experimental | Behavioral: Very Low Carbohydrate DietParticipants will follow a high protein very low carbohydrate diet (VLCD) for 2 weeks. This will be 11% of caloric intake from carbohydrates, 54% of calories from protein, and 35% of calories from fat. Immediately following this, participants will follow a high protein very low carbohydrate diet (VLCD) which will be 11% of caloric intake from carbohydrates, 23% of calories from protein, and 66% of calories from fat. |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- BMI 19-30 m2 for individuals at least 18 years old or BMI < 95 percentile for individuals less than 18 years old
- Participants 18 years of age must be able to read and provide written consent
- Participants under 18 years of age must be able to read and provide written assent
- Participants are managed using an insulin pump or injections
- Participant has or is willing to wear a CGM for the duration of the study
Key exclusion criteria (7 listed)
- A1c < 6.5% or > 10%
- Recent history of more than 1 of diabetic ketoacidosis (DKA) in the past 6 months
- Treatment with glucose-lowering drugs other than insulin
- Unstable psychiatric disorders, including eating disorders (DSM-V criteria)
- Weight loss medications within the last 6 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 |
|---|---|---|
| Very Low Carbohydrate DietA very low carbohydrate diet (VLCD), is defined as limiting carbohydrate intake to 11% of total daily caloric intake. | Behavioural | Very Low Carbohydrate Diet |
Primary outcome
Percentage of Time in Target Range of 70-180 mg/dL.
Time frame: 2 weeks per intervention, up to 7 weeks
The target range is 70 mg/dL - 180 mg/dL based on sensor-derived glucose levels. The outcome is reflected as the percentage of time spent in this range during the time frame.
6 secondary outcomes
Percentage of Time Spent > 180 mg/dL to 250 mg/dl
Time frame: 2 weeks per intervention, up to 7 weeks
Percent Time Spent > 250 mg/dL Based on Sensor-derived Glucose Values
Time frame: 2 weeks per intervention, up to 7 weeks
Percent of Time Spent > = 55 to < 70 mg/dL Based on Sensor-derived Glucose Values
Time frame: 2 weeks per intervention, up to 7 weeks
Percent Time Spent < 55 mg/dL Based on Sensor-derived Glucose Values
Time frame: 2 weeks per intervention, up to 7 weeks
Total Daily Insulin Dose
Time frame: 2 weeks per intervention, up to 7 weeks
Average Sensor Glucose Level
Time frame: 2 weeks per intervention, up to 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 Very Low Carbohydrate Diet in people with Type 1 Diabetes, run by Yale University 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 6 inclusion and 7 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 15 Feb 2024. 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?
Yes. Results are posted in the registry (first posted 5 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Time in Target Range of 70-180 mg/dL. (time frame: 2 weeks per intervention, up to 7 weeks). 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 15 Feb 2024.