Low Carbohydrate Diet vs. High Carbohydrate Diet in Type 1 Diabetes (HiLo12)

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ClinicalTrials.gov Identifier: NCT02888691
Recruitment Status : Completed
First Posted : September 5, 2016
Results First Posted : November 9, 2020
Last Update Posted : March 28, 2023
Sponsor:
Information provided by (Responsible Party):
Signe Schmidt, Copenhagen University Hospital, Hvidovre

Study Description
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Brief Summary:
The aim of the study is to investigate glycemic control during a low carbohydrate diet compared with during a high carbohydrate diet in adults with insulin pump treated type 1 diabetes.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Other: Low carbohydrate diet Other: High carbohydrate diet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low Carbohydrate Diet vs. High Carbohydrate Diet in Type 1 Diabetes: A Randomized Crossover Study
Actual Study Start Date : August 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: Low Carbohydrate Diet
< 100 grams of carbohydrate per day
 Other: Low carbohydrate diet
Experimental: High Carbohydrate Diet
> 250 grams of carbohydrate per day
 Other: High carbohydrate diet


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Time Spent in Euglycemia [ Time Frame: 12 weeks - from baseline to end of study ]
    Time spent with glucose values 4.0-10.0 mmol/l assessed by continuous glucose monitoring


Secondary Outcome Measures :
  1. Mean Glucose [ Time Frame: 12 weeks - from baseline to end of study ]
    Mean glucose value assessed by continuous glucose monitoring

  2. Standard Deviation of Glucose [ Time Frame: 12 weeks - from baseline to end of study ]
    Standard deviation of glucose values assessed by continuous glucose monitoring

  3. Coefficient of Variation of Glucose [ Time Frame: 12 weeks - from baseline to end of study ]
    Coefficient of variation of glucose values assessed by continuous glucose monitoring

  4. Mean Amplitude of Glycemic Excursions [ Time Frame: 12 weeks - from baseline to end of study ]
    Mean amplitude of glycemic excursions (MAGE) assessed by continuous glucose monitoring

  5. Time Spent in Hypoglycemia [ Time Frame: 12 weeks - from baseline to end of study ]
    Percentage of time spent with glucose values ≤ 3.9 mmol/l assessed by continuous glucose monitoring

  6. Time Spent in Hyperglycemia [ Time Frame: 12 weeks - from baseline to end of study ]
    Time spent with glucose values > 10.0 mmol/l assessed by continuous glucose monitoring

  7. Change in A1c [ Time Frame: From baseline to 12 weeks ]
    Change in hemoglobin A1c

  8. AUC Low [ Time Frame: 12 weeks - from baseline to end of study ]
    Difference in area under the curve <4.0 mmol/l assessed by continuous glucose monitoring

  9. AUC High [ Time Frame: 12 weeks - from baseline to end of study ]
    Difference in area under the curve >10.0 mmol/l assessed by continuous glucose monitoring

  10. Post Breakfast Glucose Excursion [ Time Frame: 12 weeks - from baseline to end of study ]
    Difference in post breakfast glucose excursion assessed by continuous glucose monitoring

  11. Severe Hypoglycemia [ Time Frame: From baseline to 12 weeks ]
    Number of severe hypoglycemia episodes (glucagon or intravenous glucose administration)

  12. Total Daily Dose [ Time Frame: 12 weeks - from baseline to end of study ]
    Total daily insulin dose

  13. Total Daily Basal Insulin 24 Hour [ Time Frame: 12 weeks - from baseline to end of study ]
    Total daily basal insulin dose in the time range 00:00-24:00

  14. Total Nightime Basal Insulin [ Time Frame: From baseline to 12 weeks ]
    Total nighttime basal insulin in the time range 00:00-06:00

  15. Total Daytime Basal Insulin [ Time Frame: 12 weeks - from baseline to end of study ]
    Total daytime basal insulin in the time range 06:00-24:00

  16. Total Daily Bolus Insulin [ Time Frame: 12 weeks - from baseline to end of study ]
    Difference in total daily bolus insulin

  17. Blood Glucose Readings [ Time Frame: 12 weeks - from baseline to end of study ]
    Number of blood glucose readings

  18. Carbohydrate Servings [ Time Frame: 12 weeks - from baseline to end of study ]
    Number of daily carbohydrate servings (one serving ≥ 15 grams)

  19. Body Composition [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in fat mass (% of total body weight) assessed by Dual-energy X-ray Absorptiometry

  20. Weight [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in weight

  21. Hip Circumference [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in hip circumference

  22. Waist Circumference [ Time Frame: From baseline to 12 weeks ]
    Change in waist circumference

  23. Systolic Blood Pressure [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in systolic blood pressure

  24. Diastolic Blood Pressure [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in diastolic blood pressure

  25. Heart Rate [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in heart rate

  26. Diabetes Treatment Satisfaction [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in Diabetes Treatment Satisfaction Questionnaire score. Score range: 0-36, with higher values representing higher degrees of treatment satisfaction.

  27. Hypoglycemia Fear [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in Hypoglycemia Fear Survey score. Score range: 0-52, with higher scores indicating higher degrees of fear of hypoglycemia.

  28. Cholesterol [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in total cholesterol

  29. HDL [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in HDL

  30. LDL [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in LDL

  31. Triglycerides [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in triglycerides

  32. Free Fatty Acids [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in free fatty acids

  33. Sodium [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in sodium

  34. Potassium [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in potassium

  35. Creatinine [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in creatinine

  36. Urate [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in urate

  37. Albumin [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in albumin

  38. Hemoglobin [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in hemoglobin

  39. Leucocytes [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in leucocytes

  40. Thrombocytes [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in thrombocytes

  41. Iron [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in iron

  42. Transferrin [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in transferrin

  43. Ferritin [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in ferritin

  44. Folate [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in folate

  45. Vitamin B-12 [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in vitamin B-12

  46. Magnesium [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in magnesium

  47. Zinc [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in zinc

  48. U-alb-crea Ratio [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in urine albumin-creatinine ratio

  49. Supar [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in Supar

  50. CRP [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in CRP

  51. IL-1 [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in IL-1

  52. IL-6 [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in IL-6

  53. IL-8 [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in IL-8

  54. TNF-alpha [ Time Frame: 12 weeks - from baseline to end of study ]
    Change in TNF-alpha


Other Outcome Measures:
  1. Carbohydrate Intake [ Time Frame: 12 weeks - from baseline to end of study ]
    Daily carbohydrate intake assessed by insulin pump download

  2. Ketones [ Time Frame: Spot test at week 0, 2, 4, 6, 8, 10 and 12 ]
    Morning blood ketone values obtained 7 times during the study period. A single value was calculated for each study participant based on an average of the 7 datapoints.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes ≥3 years
  • Insulin pump use ≥1 year
  • HbA1c ≥53 mmol/mol (7.0%)
  • BMI 20-27 kg/m2
  • Willingness to count carbohydrates and use the insulin pump bolus calculator for all boluses during the intervention periods
  • Willingness to use continuous glucose monitoring consistently during the intervention periods

Exclusion Criteria:

  • Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
  • Use of SGLT-2-inhibitors
  • Use of corticosteroids during or within 30 days prior to the intervention periods
  • Celiac disease
  • Inflammatory bowel disease
  • Macroalbuminuria
  • Active proliferative retinopathy combined with an HbA1c ≥ 75 mmol/mol (9.0%)
  • Known or suspected alcohol or drug abuse
  • Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
Contacts and Locations
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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): NCT02888691


Locations
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Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
  Study Documents (Full-Text)

Documents provided by Signe Schmidt, Copenhagen University Hospital, Hvidovre:
Study Protocol and Statistical Analysis Plan  [PDF] September 20, 2016

More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Signe Schmidt, MD PhD, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT02888691    
Other Study ID Numbers: HiLo12
First Posted: September 5, 2016    Key Record Dates
Results First Posted: November 9, 2020
Last Update Posted: March 28, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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