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Completed

NCT Number: NCT02888691

Low Carbohydrate Diet vs. High Carbohydrate Diet in Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low carbohydrate diet

Other

High carbohydrate diet

Other

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Low Carbohydrate Diet vs. High Carbohydrate Diet in Type 1 Diabetes: A Randomized Crossover Study

Acronym: HiLo12

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 5, 2016
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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