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Impact of a Low-Carbohydrate Diet in Pediatric Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT03997409
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
Sara Duffus, Vanderbilt University Medical Center

Brief Summary:
Dietary carbohydrate consumption is a key factor influencing postprandial glycemia for patients with type 1 diabetes mellitus (T1DM). Because post-prandial glucose excursions profoundly influence hemoglobin A1c (HbA1c), therapeutic approaches to mitigate post-prandial hyperglycemia are of great importance. The quantity and source of carbohydrates affect post-prandial glycemia more than any other dietary factor. These findings serve as the physiologic basis for a growing interest in carbohydrate-restricted diets in the management of T1DM despite American Diabetes Association (ADA) guidelines that discourage restricting total carbohydrate intake to less than 130 grams per day. Although case series and prospective studies suggest low-carbohydrate diets (LCD) significantly improve HbA1c for adults with T1DM, data in the pediatric T1DM population is limited. The investigators will conduct a randomized prospective pilot study evaluating glycemic control, lipidemia, and quality of life (QOL) in pediatric T1DM patients on a LCD.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Other: Dietary Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Impact of a Low-Carbohydrate Diet on Glycemic Control and Lipids in Pediatric Type 1 Diabetes
Actual Study Start Date : November 18, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Low Carbohydrate Diet
The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine. Participants on the LCD intervention will consume 25-35% of total daily intake from carbohydrates, 45-65% from fat and 10-30% from protein.
Other: Dietary Intervention
The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.

Active Comparator: Standard Carbohydrate Diet
The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine. Participants on the SCD intervention will consume 45-65% of total daily caloric intake from carbohydrates, 25-35% from fat and 10-30% from protein.
Other: Dietary Intervention
The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.

No Intervention: No Dietary Recommendations
This group will serve as a control that receives the same number of education sessions as LCD and SCD group to teach general diabetes management but without specific dietary recommendations.



Primary Outcome Measures :
  1. HbA1c [ Time Frame: 12 weeks ]
    HbA1c (%) change from baseline to 12 weeks will be compared between the groups


Secondary Outcome Measures :
  1. Percent of time spent in the glycemic target of 70 - 140 mg/dL [ Time Frame: 12 weeks ]
    Obtained from continuous glucose monitor data

  2. Percent of time spent above the glycemic target of 140 mg/dL [ Time Frame: 12 weeks ]
    Obtained from continuous glucose monitor data

  3. Percent of time spent below the glycemic target of 70 mg/dL [ Time Frame: 12 weeks ]
    Obtained from continuous glucose monitor data

  4. Percent of time spent in hypoglycemia below 50 mg/dL [ Time Frame: 12 weeks ]
    Obtained from continuous glucose monitor data

  5. Average blood glucose [ Time Frame: 12 weeks ]
    Change in average blood glucose (calculated from continuous glucose monitoring data) from baseline to 12 weeks will be compared between groups

  6. Blood glucose standard variation [ Time Frame: 12 weeks ]
    Change in the blood glucose standard deviation (obtained from continuous glucose monitor data) from baseline to 12 weeks will be compared between groups

  7. Average total daily dose of insulin [ Time Frame: 12 weeks ]
    Insulin pump data

  8. Average bolus amount of insulin per day [ Time Frame: 12 weeks ]
    Insulin pump data

  9. Average basal amount of insulin per day [ Time Frame: 12 weeks ]
    Insulin pump data

  10. Low density lipoprotein particle number [ Time Frame: Weeks 0 and 12 ]
    NMR spectroscopy lipoprofile

  11. High density lipoprotein particle number [ Time Frame: Weeks 0 and 12 ]
    NMR spectroscopy lipoprofile

  12. Small low density lipoprotein particle number [ Time Frame: Weeks 0 and 12 ]
    NMR spectroscopy lipoprofile

  13. Low density lipoprotein size [ Time Frame: Weeks 0 and 12 ]
    NMR spectroscopy lipoprofile

  14. Beta-hydroxybutyrate [ Time Frame: Weeks 0 and 12 ]
    Change in concentration of serum ketones (beta-hydroxybutyrate) from baseline to 12 weeks will be compared between groups

  15. Pediatric Quality of Life Inventory (PedsQL) Diabetes Module [ Time Frame: Weeks 0 and 12 ]
    Quality of Life Measure (score 0 - 100 with higher scores indicating higher QOL)

  16. Problem Areas in Diabetes: Teen Version (PAID-T) [ Time Frame: Weeks 0 and 12 ]
    Diabetes distress measure (score 0 - 156 with higher scores indicating increased distress)



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with T1DM for at least 12 months
  • Age 13 to 21 years
  • Total daily dose of insulin 0.5 to 1.25 units/kg/day
  • Current use of an insulin pump and CGM
  • HbA1c between 7% and 10%
  • Tanner stage 3 to 5 on physical exam
  • Participant or parent of participant use of smart phone
  • Able to read and speak English

Exclusion Criteria:

  • Any episode of diabetic ketoacidosis (DKA) in the last 12 months
  • Any episode of severe hypoglycemia (defined as requiring assistance from another person, including coma, seizures, or episodes requiring glucagon, IV dextrose or oral carbohydrate administered by another person) in the last 12 months
  • Any prior abnormal fasting lipid panel (LDL > 130)
  • Additional dietary restrictions
  • Following a weight-loss or otherwise restrictive diet
  • Use of medication or supplements other than insulin to control blood glucose
  • Use of medication or other supplements to lower lipids
  • Pregnancy or breast feeding
  • History of hemoglobinopathy

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): NCT03997409


Contacts
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Contact: Sara H Duffus, MD 615-875-3269 sara.duffus@vumc.org
Contact: Justin M Gregory, MD, MSCI 615-322-7424 justin.m.gregory.1@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Sara H Duffus, MD    615-875-3269    sara.duffus@vumc.org   
Contact: Justin M Gregory, MD    615-322-7427    justin.m.gregory.1@vumc.org   
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Study Director: Justin M Gregory, MD, MSCI Vanderbilt University Medical Center
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Responsible Party: Sara Duffus, Clinical Fellow, Division of Pediatric Endocrinology, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03997409    
Other Study ID Numbers: 190851
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Sara Duffus, Vanderbilt University Medical Center:
Low Carbohydrate Diet
Standard 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