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CompletedNCT02888691HiLo12Updated Mar 28, 2023Results posted

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

An interventional study of Low carbohydrate diet and High carbohydrate diet in Type 1 Diabetes, sponsored by Hvidovre University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-28.

Sponsored by Hvidovre University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Type 1 Diabetes
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 14 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Hvidovre University Hospital is the lead sponsor of 295 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • 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

Interventions

  • OtherLow carbohydrate diet
  • OtherHigh carbohydrate diet
06

What researchers measure

Primary outcomes

  1. Percentage of Time Spent in Euglycemia

    Time spent with glucose values 4.0-10.0 mmol/l assessed by continuous glucose monitoring

    Time frame: 12 weeks - from baseline to end of study

Secondary outcomes

  1. Mean Glucose

    Mean glucose value assessed by continuous glucose monitoring

    Time frame: 12 weeks - from baseline to end of study

  2. Standard Deviation of Glucose

    Standard deviation of glucose values assessed by continuous glucose monitoring

    Time frame: 12 weeks - from baseline to end of study

  3. Coefficient of Variation of Glucose

    Coefficient of variation of glucose values assessed by continuous glucose monitoring

    Time frame: 12 weeks - from baseline to end of study

  4. Mean Amplitude of Glycemic Excursions

    Mean amplitude of glycemic excursions (MAGE) assessed by continuous glucose monitoring

    Time frame: 12 weeks - from baseline to end of study

  5. Time Spent in Hypoglycemia

    Percentage of time spent with glucose values ≤ 3.9 mmol/l assessed by continuous glucose monitoring

    Time frame: 12 weeks - from baseline to end of study

  6. Time Spent in Hyperglycemia

    Time spent with glucose values \> 10.0 mmol/l assessed by continuous glucose monitoring

    Time frame: 12 weeks - from baseline to end of study

  7. Change in A1c

    Change in hemoglobin A1c

    Time frame: From baseline to 12 weeks

  8. AUC Low

    Difference in area under the curve \<4.0 mmol/l assessed by continuous glucose monitoring

    Time frame: 12 weeks - from baseline to end of study

  9. AUC High

    Difference in area under the curve \>10.0 mmol/l assessed by continuous glucose monitoring

    Time frame: 12 weeks - from baseline to end of study

  10. Post Breakfast Glucose Excursion

    Difference in post breakfast glucose excursion assessed by continuous glucose monitoring

    Time frame: 12 weeks - from baseline to end of study

  11. Severe Hypoglycemia

    Number of severe hypoglycemia episodes (glucagon or intravenous glucose administration)

    Time frame: From baseline to 12 weeks

  12. Total Daily Dose

    Total daily insulin dose

    Time frame: 12 weeks - from baseline to end of study

  13. Total Daily Basal Insulin 24 Hour

    Total daily basal insulin dose in the time range 00:00-24:00

    Time frame: 12 weeks - from baseline to end of study

  14. Total Nightime Basal Insulin

    Total nighttime basal insulin in the time range 00:00-06:00

    Time frame: From baseline to 12 weeks

  15. Total Daytime Basal Insulin

    Total daytime basal insulin in the time range 06:00-24:00

    Time frame: 12 weeks - from baseline to end of study

  16. Total Daily Bolus Insulin

    Difference in total daily bolus insulin

    Time frame: 12 weeks - from baseline to end of study

  17. Blood Glucose Readings

    Number of blood glucose readings

    Time frame: 12 weeks - from baseline to end of study

  18. Carbohydrate Servings

    Number of daily carbohydrate servings (one serving ≥ 15 grams)

    Time frame: 12 weeks - from baseline to end of study

  19. Body Composition

    Change in fat mass (% of total body weight) assessed by Dual-energy X-ray Absorptiometry

    Time frame: 12 weeks - from baseline to end of study

  20. Weight

    Change in weight

    Time frame: 12 weeks - from baseline to end of study

  21. Hip Circumference

    Change in hip circumference

    Time frame: 12 weeks - from baseline to end of study

  22. Waist Circumference

    Change in waist circumference

    Time frame: From baseline to 12 weeks

  23. Systolic Blood Pressure

    Change in systolic blood pressure

    Time frame: 12 weeks - from baseline to end of study

  24. Diastolic Blood Pressure

    Change in diastolic blood pressure

    Time frame: 12 weeks - from baseline to end of study

  25. Heart Rate

    Change in heart rate

    Time frame: 12 weeks - from baseline to end of study

  26. Diabetes Treatment Satisfaction

    Change in Diabetes Treatment Satisfaction Questionnaire score. Score range: 0-36, with higher values representing higher degrees of treatment satisfaction.

    Time frame: 12 weeks - from baseline to end of study

  27. Hypoglycemia Fear

    Change in Hypoglycemia Fear Survey score. Score range: 0-52, with higher scores indicating higher degrees of fear of hypoglycemia.

    Time frame: 12 weeks - from baseline to end of study

  28. Cholesterol

    Change in total cholesterol

    Time frame: 12 weeks - from baseline to end of study

  29. HDL

    Change in HDL

    Time frame: 12 weeks - from baseline to end of study

  30. LDL

    Change in LDL

    Time frame: 12 weeks - from baseline to end of study

  31. Triglycerides

    Change in triglycerides

    Time frame: 12 weeks - from baseline to end of study

  32. Free Fatty Acids

    Change in free fatty acids

    Time frame: 12 weeks - from baseline to end of study

  33. Sodium

    Change in sodium

    Time frame: 12 weeks - from baseline to end of study

  34. Potassium

    Change in potassium

    Time frame: 12 weeks - from baseline to end of study

  35. Creatinine

    Change in creatinine

    Time frame: 12 weeks - from baseline to end of study

  36. Urate

    Change in urate

    Time frame: 12 weeks - from baseline to end of study

  37. Albumin

    Change in albumin

    Time frame: 12 weeks - from baseline to end of study

  38. Hemoglobin

    Change in hemoglobin

    Time frame: 12 weeks - from baseline to end of study

  39. Leucocytes

    Change in leucocytes

    Time frame: 12 weeks - from baseline to end of study

  40. Thrombocytes

    Change in thrombocytes

    Time frame: 12 weeks - from baseline to end of study

  41. Iron

    Change in iron

    Time frame: 12 weeks - from baseline to end of study

  42. Transferrin

    Change in transferrin

    Time frame: 12 weeks - from baseline to end of study

  43. Ferritin

    Change in ferritin

    Time frame: 12 weeks - from baseline to end of study

  44. Folate

    Change in folate

    Time frame: 12 weeks - from baseline to end of study

  45. Vitamin B-12

    Change in vitamin B-12

    Time frame: 12 weeks - from baseline to end of study

  46. Magnesium

    Change in magnesium

    Time frame: 12 weeks - from baseline to end of study

  47. Zinc

    Change in zinc

    Time frame: 12 weeks - from baseline to end of study

  48. U-alb-crea Ratio

    Change in urine albumin-creatinine ratio

    Time frame: 12 weeks - from baseline to end of study

  49. Supar

    Change in Supar

    Time frame: 12 weeks - from baseline to end of study

  50. CRP

    Change in CRP

    Time frame: 12 weeks - from baseline to end of study

  51. IL-1

    Change in IL-1

    Time frame: 12 weeks - from baseline to end of study

  52. IL-6

    Change in IL-6

    Time frame: 12 weeks - from baseline to end of study

  53. IL-8

    Change in IL-8

    Time frame: 12 weeks - from baseline to end of study

  54. TNF-alpha

    Change in TNF-alpha

    Time frame: 12 weeks - from baseline to end of study

Other outcomes

  1. Carbohydrate Intake

    Daily carbohydrate intake assessed by insulin pump download

    Time frame: 12 weeks - from baseline to end of study

  2. Ketones

    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.

    Time frame: Spot test at week 0, 2, 4, 6, 8, 10 and 12

07

Results

Posted Nov 9, 2020

Participant flow

First Intervention Period
Participant flow — First Intervention Period
MilestoneLow Carbohydrate DietHigh Carbohydrate Diet
Started77
Completed67
Not completed10
Second Intervention Period
Participant flow — Second Intervention Period
MilestoneLow Carbohydrate DietHigh Carbohydrate Diet
Started75
Completed73
Not completed02

Outcome measures

PrimaryPercentage of Time Spent in Euglycemia

Time spent with glucose values 4.0-10.0 mmol/l assessed by continuous glucose monitoring

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · Percentage of time
Percentage of Time Spent in Euglycemia
Percentage of timeLow Carbohydrate DietHigh Carbohydrate Diet
Percentage of Time Spent in Euglycemia68.6 ± 8.965.3 ± 6.5
SecondaryMean Glucose

Mean glucose value assessed by continuous glucose monitoring

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · mmol/l
Mean Glucose
mmol/lLow Carbohydrate DietHigh Carbohydrate Diet
Mean Glucose8.8 ± 0.78.9 ± 0.7
SecondaryStandard Deviation of Glucose

Standard deviation of glucose values assessed by continuous glucose monitoring

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · mmol/l
Standard Deviation of Glucose
mmol/lLow Carbohydrate DietHigh Carbohydrate Diet
Standard Deviation of Glucose2.9 ± 0.43.3 ± 0.4
SecondaryCoefficient of Variation of Glucose

Coefficient of variation of glucose values assessed by continuous glucose monitoring

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · percentage
Coefficient of Variation of Glucose
percentageLow Carbohydrate DietHigh Carbohydrate Diet
Coefficient of Variation of Glucose32.7 ± 3.237.5 ± 3.6
SecondaryMean Amplitude of Glycemic Excursions

Mean amplitude of glycemic excursions (MAGE) assessed by continuous glucose monitoring

Time frame:
12 weeks - from baseline to end of study

No measurements were reported for this outcome.

SecondaryTime Spent in Hypoglycemia

Percentage of time spent with glucose values ≤ 3.9 mmol/l assessed by continuous glucose monitoring

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · Percentage of time
Time Spent in Hypoglycemia
Percentage of timeLow Carbohydrate DietHigh Carbohydrate Diet
Time Spent in Hypoglycemia1.9 ± 1.83.6 ± 2.1
SecondaryTime Spent in Hyperglycemia

Time spent with glucose values \> 10.0 mmol/l assessed by continuous glucose monitoring

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · Percentage of time
Time Spent in Hyperglycemia
Percentage of timeLow Carbohydrate DietHigh Carbohydrate Diet
Time Spent in Hyperglycemia29.5 ± 9.031.1 ± 7.3
SecondaryChange in A1c

Change in hemoglobin A1c

Time frame:
From baseline to 12 weeks
Reported as:
Mean · mmol/mol
Change in A1c
mmol/molLow Carbohydrate DietHigh Carbohydrate Diet
Change in A1c1 ± 11 ± 0
SecondaryAUC Low

Difference in area under the curve \<4.0 mmol/l assessed by continuous glucose monitoring

Time frame:
12 weeks - from baseline to end of study

No measurements were reported for this outcome.

SecondaryAUC High

Difference in area under the curve \>10.0 mmol/l assessed by continuous glucose monitoring

Time frame:
12 weeks - from baseline to end of study

No measurements were reported for this outcome.

SecondaryPost Breakfast Glucose Excursion

Difference in post breakfast glucose excursion assessed by continuous glucose monitoring

Time frame:
12 weeks - from baseline to end of study

No measurements were reported for this outcome.

SecondarySevere Hypoglycemia

Number of severe hypoglycemia episodes (glucagon or intravenous glucose administration)

Time frame:
From baseline to 12 weeks
Reported as:
Number · events
Severe Hypoglycemia
eventsLow Carbohydrate DietHigh Carbohydrate Diet
Severe Hypoglycemia00
SecondaryTotal Daily Dose

Total daily insulin dose

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · Units of insulin
Total Daily Dose
Units of insulinLow Carbohydrate DietHigh Carbohydrate Diet
Total Daily Dose33.6 ± 8.143.2 ± 11.0
SecondaryTotal Daily Basal Insulin 24 Hour

Total daily basal insulin dose in the time range 00:00-24:00

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · Units of insulin
Total Daily Basal Insulin 24 Hour
Units of insulinLow Carbohydrate DietHigh Carbohydrate Diet
Total Daily Basal Insulin 24 Hour18.5 ± 5.417.3 ± 5.4
SecondaryTotal Nightime Basal Insulin

Total nighttime basal insulin in the time range 00:00-06:00

Time frame:
From baseline to 12 weeks

Results for this outcome have not been posted.

SecondaryTotal Daytime Basal Insulin

Total daytime basal insulin in the time range 06:00-24:00

Time frame:
12 weeks - from baseline to end of study

Results for this outcome have not been posted.

SecondaryTotal Daily Bolus Insulin

Difference in total daily bolus insulin

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · Units of insulin
Total Daily Bolus Insulin
Units of insulinLow Carbohydrate DietHigh Carbohydrate Diet
Total Daily Bolus Insulin15.1 ± 4.425.9 ± 7.3
SecondaryBlood Glucose Readings

Number of blood glucose readings

Time frame:
12 weeks - from baseline to end of study

Results for this outcome have not been posted.

SecondaryCarbohydrate Servings

Number of daily carbohydrate servings (one serving ≥ 15 grams)

Time frame:
12 weeks - from baseline to end of study

Results for this outcome have not been posted.

SecondaryBody Composition

Change in fat mass (% of total body weight) assessed by Dual-energy X-ray Absorptiometry

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · percentage of total body weight
Body Composition
percentage of total body weightLow Carbohydrate DietHigh Carbohydrate Diet
Body Composition-0.2 ± 0.61.0 ± 0.0
SecondaryWeight

Change in weight

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · kilogram
Weight
kilogramLow Carbohydrate DietHigh Carbohydrate Diet
Weight1.9 ± 0.31.7 ± 1.6
SecondaryHip Circumference

Change in hip circumference

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · centimeter
Hip Circumference
centimeterLow Carbohydrate DietHigh Carbohydrate Diet
Hip Circumference5.2 ± 10.84.6 ± 0.4
SecondaryWaist Circumference

Change in waist circumference

Time frame:
From baseline to 12 weeks
Reported as:
Mean · centimeter
Waist Circumference
centimeterLow Carbohydrate DietHigh Carbohydrate Diet
Waist Circumference-1.9 ± 0.50.0 ± 1.8
SecondarySystolic Blood Pressure

Change in systolic blood pressure

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · mmHg
Systolic Blood Pressure
mmHgLow Carbohydrate DietHigh Carbohydrate Diet
Systolic Blood Pressure4 ± 112 ± 5
SecondaryDiastolic Blood Pressure

Change in diastolic blood pressure

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · mmHg
Diastolic Blood Pressure
mmHgLow Carbohydrate DietHigh Carbohydrate Diet
Diastolic Blood Pressure2 ± 47 ± 4
SecondaryHeart Rate

Change in heart rate

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · beats per minute
Heart Rate
beats per minuteLow Carbohydrate DietHigh Carbohydrate Diet
Heart Rate3 ± 01 ± 1
SecondaryDiabetes Treatment Satisfaction

Change in Diabetes Treatment Satisfaction Questionnaire score. Score range: 0-36, with higher values representing higher degrees of treatment satisfaction.

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · units on a scale
Diabetes Treatment Satisfaction
units on a scaleLow Carbohydrate DietHigh Carbohydrate Diet
Diabetes Treatment Satisfaction3.8 ± 2.74.9 ± 4.6
SecondaryHypoglycemia Fear

Change in Hypoglycemia Fear Survey score. Score range: 0-52, with higher scores indicating higher degrees of fear of hypoglycemia.

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · units on a scale
Hypoglycemia Fear
units on a scaleLow Carbohydrate DietHigh Carbohydrate Diet
Hypoglycemia Fear0 ± 0.92.5 ± 6.0
SecondaryCholesterol

Change in total cholesterol

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · mmol/l
Cholesterol
mmol/lLow Carbohydrate DietHigh Carbohydrate Diet
Cholesterol0.4 ± 0.00.2 ± 0.3
SecondaryHDL

Change in HDL

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · mmol/l
HDL
mmol/lLow Carbohydrate DietHigh Carbohydrate Diet
HDL0.6 ± 0.00.03 ± 0.05
SecondaryLDL

Change in LDL

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · mmol/l
LDL
mmol/lLow Carbohydrate DietHigh Carbohydrate Diet
LDL0.2 ± 0.00.2 ± 0.2
SecondaryTriglycerides

Change in triglycerides

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · mmol/l
Triglycerides
mmol/lLow Carbohydrate DietHigh Carbohydrate Diet
Triglycerides0.0 ± 0.10.1 ± 0.0
SecondaryFree Fatty Acids

Change in free fatty acids

Time frame:
12 weeks - from baseline to end of study

Results for this outcome have not been posted.

SecondarySodium

Change in sodium

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · mmol/l
Sodium
mmol/lLow Carbohydrate DietHigh Carbohydrate Diet
Sodium0 ± 11 ± 1
SecondaryPotassium

Change in potassium

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · mmol/l
Potassium
mmol/lLow Carbohydrate DietHigh Carbohydrate Diet
Potassium0.2 ± 0.00.1 ± 0.1
SecondaryCreatinine

Change in creatinine

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · micromol/l
Creatinine
micromol/lLow Carbohydrate DietHigh Carbohydrate Diet
Creatinine2 ± 12 ± 1
SecondaryUrate

Change in urate

Time frame:
12 weeks - from baseline to end of study

Results for this outcome have not been posted.

SecondaryAlbumin

Change in albumin

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · g/l
Albumin
g/lLow Carbohydrate DietHigh Carbohydrate Diet
Albumin1 ± 10 ± 0
SecondaryHemoglobin

Change in hemoglobin

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · mmol/l
Hemoglobin
mmol/lLow Carbohydrate DietHigh Carbohydrate Diet
Hemoglobin0.3 ± 0.10.2 ± 0.0
SecondaryLeucocytes

Change in leucocytes

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · cells/l
Leucocytes
cells/lLow Carbohydrate DietHigh Carbohydrate Diet
Leucocytes0.1 ± 0.20.2 ± 0.1
SecondaryThrombocytes

Change in thrombocytes

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · cells/l
Thrombocytes
cells/lLow Carbohydrate DietHigh Carbohydrate Diet
Thrombocytes17 ± 16 ± 10
SecondaryIron

Change in iron

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · micromol/l
Iron
micromol/lLow Carbohydrate DietHigh Carbohydrate Diet
Iron2 ± 44 ± 0
SecondaryTransferrin

Change in transferrin

Time frame:
12 weeks - from baseline to end of study

Results for this outcome have not been posted.

SecondaryFerritin

Change in ferritin

Time frame:
12 weeks - from baseline to end of study

Results for this outcome have not been posted.

SecondaryFolate

Change in folate

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · micromol/l
Folate
micromol/lLow Carbohydrate DietHigh Carbohydrate Diet
Folate0.5 ± 0.10.3 ± 0.9
SecondaryVitamin B-12

Change in vitamin B-12

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · pmol/l
Vitamin B-12
pmol/lLow Carbohydrate DietHigh Carbohydrate Diet
Vitamin B-1218 ± 835 ± 10
SecondaryMagnesium

Change in magnesium

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · mmol/l
Magnesium
mmol/lLow Carbohydrate DietHigh Carbohydrate Diet
Magnesium0.03 ± 0.000.02 ± 0.00
SecondaryZinc

Change in zinc

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · micromol/l
Zinc
micromol/lLow Carbohydrate DietHigh Carbohydrate Diet
Zinc1 ± 10 ± 1
SecondaryU-alb-crea Ratio

Change in urine albumin-creatinine ratio

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · mg/mmol
U-alb-crea Ratio
mg/mmolLow Carbohydrate DietHigh Carbohydrate Diet
U-alb-crea Ratio1 ± 43 ± 1
SecondarySupar

Change in Supar

Time frame:
12 weeks - from baseline to end of study

Results for this outcome have not been posted.

SecondaryCRP

Change in CRP

Time frame:
12 weeks - from baseline to end of study

Results for this outcome have not been posted.

SecondaryIL-1

Change in IL-1

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · pg/ml
IL-1
pg/mlLow Carbohydrate DietHigh Carbohydrate Diet
IL-10.2 ± 0.30.9 ± 1.1
SecondaryIL-6

Change in IL-6

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · pg/ml
IL-6
pg/mlLow Carbohydrate DietHigh Carbohydrate Diet
IL-61.8 ± 7.16.5 ± 4.3
SecondaryIL-8

Change in IL-8

Time frame:
12 weeks - from baseline to end of study

Results for this outcome have not been posted.

SecondaryTNF-alpha

Change in TNF-alpha

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · pg/ml
TNF-alpha
pg/mlLow Carbohydrate DietHigh Carbohydrate Diet
TNF-alpha2.3 ± 3.02.8 ± 2.6
Other pre-specifiedCarbohydrate Intake

Daily carbohydrate intake assessed by insulin pump download

Time frame:
12 weeks - from baseline to end of study
Reported as:
Mean · grams per day
Carbohydrate Intake
grams per dayLow Carbohydrate DietHigh Carbohydrate Diet
Carbohydrate Intake98 ± 11246 ± 34
Other pre-specifiedKetones

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.

Time frame:
Spot test at week 0, 2, 4, 6, 8, 10 and 12
Reported as:
Mean · mmol/l
Ketones
mmol/lLow Carbohydrate DietHigh Carbohydrate Diet
Ketones0.2 ± 0.10.1 ± 0.0

Adverse events

Collected over 36 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Low Carbohydrate Diet0/14 (0%)1/14 (7.1%)0/14 (0%)
High Carbohydrate Diet0/12 (0%)0/12 (0%)0/12 (0%)
Most frequent serious events
Most frequent serious events
EventLow Carbohydrate DietHigh Carbohydrate Diet
Diabetic ketoacidosisEndocrine disorders1/140/12

Baseline characteristics

Age, Continuous
Age, Continuous(years)Study Cohort
Mean44 ± 12
Sex: Female, Male
Sex: Female, Male(Participants)Study Cohort
Female8
Male6
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Study Cohort
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White14
More than one race0
Unknown or Not Reported0
body mass index
body mass index(kg/m*m)Study Cohort
Median25 (23.7 to 26.4)
diabetes duration
diabetes duration(years)Study Cohort
Median19 (13 to 32)
HbA1c
HbA1c(mmol/mol)Study Cohort
Median58 (55 to 60)
insulin pump use
insulin pump use(years)Study Cohort
Median7 (5 to 11)
daily carbohydrate intake
daily carbohydrate intake(grams)Study Cohort
Median145 (135 to 177)
08

Study locations

1 site
  • Hvidovre University Hospital
    Hvidovre, 2650, Denmark
09

References and documents

Publications

  • Schmidt S, Christensen MB, Serifovski N, Damm-Frydenberg C, Jensen JB, Floyel T, Storling J, Ranjan A, Norgaard K. Low versus high carbohydrate diet in type 1 diabetes: A 12-week randomized open-label crossover study. Diabetes Obes Metab. 2019 Jul;21(7):1680-1688. doi: 10.1111/dom.13725. Epub 2019 Apr 21. PubMed 30924570 ↗
  • Ji L, Li L, Ma J, Li X, Li D, Meng B, Lu W, Sun J, Liu Y, Takayanagi G, Wang Y. Efficacy and safety of teneligliptin added to metformin in Chinese patients with type 2 diabetes mellitus inadequately controlled with metformin: A phase 3, randomized, double-blind, placebo-controlled study. Endocrinol Diabetes Metab. 2021 Jan 20;4(2):e00222. doi: 10.1002/edm2.222. eCollection 2021 Apr. PubMed 33855222 ↗
  • Al-Sari N, Schmidt S, Suvitaival T, Kim M, Trost K, Ranjan AG, Christensen MB, Overgaard AJ, Pociot F, Norgaard K, Legido-Quigley C. Changes in the lipidome in type 1 diabetes following low carbohydrate diet: Post-hoc analysis of a randomized crossover trial. Endocrinol Diabetes Metab. 2021 Jan 4;4(2):e00213. doi: 10.1002/edm2.213. eCollection 2021 Apr. PubMed 33855215 ↗

Study documents

  • Protocol and statistical analysis plan · Sep 20, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02888691
Lead sponsor
Hvidovre University Hospital
Responsible party
Signe Schmidt (MD PhD, Copenhagen University Hospital, Hvidovre) — Principal investigator
First posted
Sep 5, 2016
Start date
Aug 2016
Primary completion
Nov 2017
Completion
Nov 2017
Results posted
Nov 9, 2020
Last update
Mar 28, 2023

Oversight

Data monitoring committee
No
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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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