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

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ClinicalTrials.gov Identifier: NCT04082884
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : July 1, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: Very Low Carbohydrate Diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Sequential Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Very Low Carbohydrate Diet as an Adjunctive Therapy for Youth Type 1 Diabetes
Actual Study Start Date : June 25, 2020
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Very Low Carbohydrate Diet
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.
Behavioral: Very Low Carbohydrate Diet
A very low carbohydrate diet (VLCD), is defined as limiting carbohydrate intake to 11% of total daily caloric intake.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Time spent > 180 mg/dL [ Time Frame: 2 weeks ]
    The total time spent > 180 mg/dL based on sensor-derived glucose values (minutes).

  2. 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).

  3. 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).

  4. 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).

  5. 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.

  6. Average sensor glucose level [ Time Frame: 2 weeks ]
    The average sensor glucose level recorded by the continuous glucose monitor over the 2 week dietary period.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 < 7% 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

Information from the National Library of Medicine

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


Contacts
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Contact: Laura Nally, MD 203-785-5831 laura.nally@yale.edu
Contact: Jennifer Finnegan 203-737-7199

Locations
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United States, Connecticut
Yale-New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06511
Contact: Laura Nally, MD    203-785-5831    laura.nally@yale.edu   
Contact: Amy Steffen    203-737-8852      
Sponsors and Collaborators
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04082884    
Other Study ID Numbers: 2000026189
2K12DK094714-06 ( U.S. NIH Grant/Contract )
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
very low carbohydrate diet
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases