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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 : Not yet recruiting
First Posted : September 9, 2019
Last Update Posted : October 7, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE September 6, 2019
First Posted Date  ICMJE September 9, 2019
Last Update Posted Date October 7, 2019
Estimated Study Start Date  ICMJE December 15, 2019
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2019)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04082884 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Very Low Carbohydrate Diet as an Adjunctive Therapy for Youth Type 1 Diabetes
Official Title  ICMJE Very Low Carbohydrate Diet as an Adjunctive Therapy for Youth Type 1 Diabetes
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

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE Behavioral: VLCD
A very low carbohydrate diet (VLCD), is defined as limiting carbohydrate intake to 50 grams per day or less.
Study Arms  ICMJE Diet Intervention
Participants will use a very low carbohydrate diet (VLCD), is defined as limiting carbohydrate intake to 50 grams per day or less.
Intervention: Behavioral: VLCD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 6, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laura Nally, MD 203-785-5831 laura.nally@yale.edu
Contact: Jennifer Finnegan 203-737-7199
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04082884
Other Study ID Numbers  ICMJE 2000026189
2K12DK094714-06 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE Not Provided
PRS Account Yale University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP