Very Low Carbohydrate Diet as an Adjunctive Therapy for Youth Type 1 Diabetes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04082884

Enrollment

Registered

2019-09-09

Start date

2020-06-25

Completion date

2022-02-20

Last updated

2024-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

very low carbohydrate diet

Brief 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.

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.

Interventions

BEHAVIORALVery Low Carbohydrate Diet

A very low carbohydrate diet (VLCD), is defined as limiting carbohydrate intake to 11% of total daily caloric intake.

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

13 Years to 25 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Time in Target Range of 70-180 mg/dL.	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.

Secondary

Measure	Time frame	Description
Percent Time Spent > 250 mg/dL Based on Sensor-derived Glucose Values	2 weeks per intervention, up to 7 weeks	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.
Percent of Time Spent > = 55 to < 70 mg/dL Based on Sensor-derived Glucose Values	2 weeks per intervention, up to 7 weeks	The percent of time spent \> = 55 to \< 70 mg/dL based on sensor-derived glucose values. Reflected is the percentage of time within range.
Percentage of Time Spent > 180 mg/dL to 250 mg/dl	2 weeks per intervention, up to 7 weeks	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.
Total Daily Insulin Dose	2 weeks per intervention, up to 7 weeks	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.
Average Sensor Glucose Level	2 weeks per intervention, up to 7 weeks	The average sensor glucose level recorded by the continuous glucose monitor over the 2 week dietary period in mg/dL.
Percent Time Spent < 55 mg/dL Based on Sensor-derived Glucose Values	2 weeks per intervention, up to 7 weeks	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Overall Participants Participants were youth ages 14-23 with a diagnosis of type 1 diabetes.	6
Total	6

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	Overall Participants
Age, Customized Age in years categorized 10-19 years	3 Participants
Age, Customized Age in years categorized 20-29 years	3 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	5 Participants
Region of Enrollment United States	6 participants
Sex: Female, Male Female	5 Participants
Sex: Female, Male Male	1 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 6
other Total, other adverse events	0 / 6
serious Total, serious adverse events	0 / 6

Outcome results

Primary

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.

Time frame: 2 weeks per intervention, up to 7 weeks