Very Low Carbohydrate Diet as an Adjunctive Therapy for Youth Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT04082884|
Recruitment Status : Not yet recruiting
First Posted : September 9, 2019
Last Update Posted : October 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Behavioral: VLCD||Not Applicable|
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.
Further, changes in glucose and glycerol metabolic fluxes using stable isotopes and indirect calorimetry will be assessed to measure rates of fat oxidation before and after 2 weeks of a VLCD. Arginine infusion will used to assess changes in plasma glucagon responses with the VLCD.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Very Low Carbohydrate Diet as an Adjunctive Therapy for Youth Type 1 Diabetes|
|Estimated Study Start Date :||December 15, 2019|
|Estimated Primary Completion Date :||July 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Participants will use a very low carbohydrate diet (VLCD), is defined as limiting carbohydrate intake to 50 grams per day or less.
A very low carbohydrate diet (VLCD), is defined as limiting carbohydrate intake to 50 grams per day or less.
- Time in target range [ Time Frame: 2 weeks ]The target range is 70 mg/dL - 180 mg/dL based on sensor-derived glucose levels (minutes).
- Time spent > 180 mg/dL [ Time Frame: 2 weeks ]The total time spent > 180 mg/dL based on sensor-derived glucose values (minutes).
- Time spent > 250 mg/dL based on sensor-derived glucose values [ Time Frame: 2 weeks ]The total time spent > 250 mg/dL based on sensor-derived glucose values (minutes).
- Time spent < 70 mg/dL based on sensor-derived glucose values [ Time Frame: 2 weeks ]The total time spent < 70 mg/dL based on sensor-derived glucose values (minutes).
- Time spent < 55 mg/dL based on sensor-derivted glucose values [ Time Frame: 2 weeks ]The total time spent < 55 mg/dL based on sensor-derived glucose values (minutes).
- Total Daily Insulin Dose [ Time Frame: 2 weeks ]The total daily insulin dose will be defined as the average total daily insulin dose will be calculated over 2 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082884
|Contact: Laura Nally, MDemail@example.com|
|Contact: Jennifer Finnegan||203-737-7199|
|United States, Connecticut|
|Yale-New Haven Hospital||Not yet recruiting|
|New Haven, Connecticut, United States, 06511|
|Contact: Laura Nally, MD 203-785-5831 firstname.lastname@example.org|
|Contact: Jennifer Finnegan 203-737-7199|