Type 1 Diabetes
Conditions
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.
Interventions
OTHERLow carbohydrate diet
Sponsors
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time Spent in Euglycemia | 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
| Measure | Time frame | Description |
|---|---|---|
| Potassium | 12 weeks - from baseline to end of study | Change in potassium |
| Mean Glucose | 12 weeks - from baseline to end of study | Mean glucose value assessed by continuous glucose monitoring |
| Standard Deviation of Glucose | 12 weeks - from baseline to end of study | Standard deviation of glucose values assessed by continuous glucose monitoring |
| Coefficient of Variation of Glucose | 12 weeks - from baseline to end of study | Coefficient of variation of glucose values assessed by continuous glucose monitoring |
| Mean Amplitude of Glycemic Excursions | 12 weeks - from baseline to end of study | Mean amplitude of glycemic excursions (MAGE) assessed by continuous glucose monitoring |
| Time Spent in Hypoglycemia | 12 weeks - from baseline to end of study | Percentage of time spent with glucose values ≤ 3.9 mmol/l assessed by continuous glucose monitoring |
| Time Spent in Hyperglycemia | 12 weeks - from baseline to end of study | Time spent with glucose values \> 10.0 mmol/l assessed by continuous glucose monitoring |
| Change in A1c | From baseline to 12 weeks | Change in hemoglobin A1c |
| AUC Low | 12 weeks - from baseline to end of study | Difference in area under the curve \<4.0 mmol/l assessed by continuous glucose monitoring |
| AUC High | 12 weeks - from baseline to end of study | Difference in area under the curve \>10.0 mmol/l assessed by continuous glucose monitoring |
| Post Breakfast Glucose Excursion | 12 weeks - from baseline to end of study | Difference in post breakfast glucose excursion assessed by continuous glucose monitoring |
| Severe Hypoglycemia | From baseline to 12 weeks | Number of severe hypoglycemia episodes (glucagon or intravenous glucose administration) |
| Total Daily Dose | 12 weeks - from baseline to end of study | Total daily insulin dose |
| Total Daily Basal Insulin 24 Hour | 12 weeks - from baseline to end of study | Total daily basal insulin dose in the time range 00:00-24:00 |
| Total Nightime Basal Insulin | From baseline to 12 weeks | Total nighttime basal insulin in the time range 00:00-06:00 |
| Total Daytime Basal Insulin | 12 weeks - from baseline to end of study | Total daytime basal insulin in the time range 06:00-24:00 |
| Total Daily Bolus Insulin | 12 weeks - from baseline to end of study | Difference in total daily bolus insulin |
| Blood Glucose Readings | 12 weeks - from baseline to end of study | Number of blood glucose readings |
| Carbohydrate Servings | 12 weeks - from baseline to end of study | Number of daily carbohydrate servings (one serving ≥ 15 grams) |
| Body Composition | 12 weeks - from baseline to end of study | Change in fat mass (% of total body weight) assessed by Dual-energy X-ray Absorptiometry |
| Weight | 12 weeks - from baseline to end of study | Change in weight |
| Hip Circumference | 12 weeks - from baseline to end of study | Change in hip circumference |
| Waist Circumference | From baseline to 12 weeks | Change in waist circumference |
| Systolic Blood Pressure | 12 weeks - from baseline to end of study | Change in systolic blood pressure |
| Diastolic Blood Pressure | 12 weeks - from baseline to end of study | Change in diastolic blood pressure |
| Heart Rate | 12 weeks - from baseline to end of study | Change in heart rate |
| Diabetes Treatment Satisfaction | 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. |
| Hypoglycemia Fear | 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. |
| Cholesterol | 12 weeks - from baseline to end of study | Change in total cholesterol |
| HDL | 12 weeks - from baseline to end of study | Change in HDL |
| LDL | 12 weeks - from baseline to end of study | Change in LDL |
| Triglycerides | 12 weeks - from baseline to end of study | Change in triglycerides |
| Free Fatty Acids | 12 weeks - from baseline to end of study | Change in free fatty acids |
| Sodium | 12 weeks - from baseline to end of study | Change in sodium |
| Creatinine | 12 weeks - from baseline to end of study | Change in creatinine |
| Urate | 12 weeks - from baseline to end of study | Change in urate |
| Albumin | 12 weeks - from baseline to end of study | Change in albumin |
| Hemoglobin | 12 weeks - from baseline to end of study | Change in hemoglobin |
| Leucocytes | 12 weeks - from baseline to end of study | Change in leucocytes |
| Thrombocytes | 12 weeks - from baseline to end of study | Change in thrombocytes |
| Iron | 12 weeks - from baseline to end of study | Change in iron |
| Transferrin | 12 weeks - from baseline to end of study | Change in transferrin |
| Ferritin | 12 weeks - from baseline to end of study | Change in ferritin |
| Folate | 12 weeks - from baseline to end of study | Change in folate |
| Vitamin B-12 | 12 weeks - from baseline to end of study | Change in vitamin B-12 |
| Magnesium | 12 weeks - from baseline to end of study | Change in magnesium |
| Zinc | 12 weeks - from baseline to end of study | Change in zinc |
| U-alb-crea Ratio | 12 weeks - from baseline to end of study | Change in urine albumin-creatinine ratio |
| IL-8 | 12 weeks - from baseline to end of study | Change in IL-8 |
| TNF-alpha | 12 weeks - from baseline to end of study | Change in TNF-alpha |
| Supar | 12 weeks - from baseline to end of study | Change in Supar |
| CRP | 12 weeks - from baseline to end of study | Change in CRP |
| IL-1 | 12 weeks - from baseline to end of study | Change in IL-1 |
| IL-6 | 12 weeks - from baseline to end of study | Change in IL-6 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Carbohydrate Intake | 12 weeks - from baseline to end of study | Daily carbohydrate intake assessed by insulin pump download |
| Ketones | 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. |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Cohort Baseline characteristics are for the whole study cohort, not for each of study arm of the cross-over study | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Study Cohort |
|---|---|
| Age, Continuous | 44 years STANDARD_DEVIATION 12 |
| body mass index | 25 kg/m*m |
| daily carbohydrate intake | 145 grams |
| diabetes duration | 19 years |
| HbA1c | 58 mmol/mol |
| insulin pump use | 7 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 12 |
| other Total, other adverse events | 0 / 14 | 0 / 12 |
| serious Total, serious adverse events | 1 / 14 | 0 / 12 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Percentage of Time Spent in Euglycemia | 68.6 Percentage of time | Standard Deviation 8.9 |
| High Carbohydrate Diet | Percentage of Time Spent in Euglycemia | 65.3 Percentage of time | Standard Deviation 6.5 |
Secondary
Albumin
Change in albumin
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Albumin | 1 g/l | Standard Deviation 1 |
| High Carbohydrate Diet | Albumin | 0 g/l | Standard Deviation 0 |
Secondary
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
Population: CGM data were collected, but the calculation of AUC high was not conducted. The analysis plan was changed as a result of changes in the guidelines for reporting of CGM-based measures. To calculate AUC high would require extensive work, and the results would be of no clinical relevance. Funding aquired for this project covers only clinically relevant analysis and ultimately, AUC high was not calculated due to lack of funding.
Secondary
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
Population: CGM data were collected, but the calculation of AUC low was not conducted. The analysis plan was changed as a result of changes in the guidelines for reporting of CGM-based measures. To calculate AUC low would require extensive work, and the results would be of no clinical relevance. Funding aquired for this project covers only clinically relevant analysis and ultimately, AUC low was not calculated due to lack of funding.
Secondary
Blood Glucose Readings
Number of blood glucose readings
Time frame: 12 weeks - from baseline to end of study
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Body Composition | -0.2 percentage of total body weight | Standard Deviation 0.6 |
| High Carbohydrate Diet | Body Composition | 1.0 percentage of total body weight | Standard Deviation 0 |
Secondary
Carbohydrate Servings
Number of daily carbohydrate servings (one serving ≥ 15 grams)
Time frame: 12 weeks - from baseline to end of study
Secondary
Change in A1c
Change in hemoglobin A1c
Time frame: From baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Change in A1c | 1 mmol/mol | Standard Deviation 1 |
| High Carbohydrate Diet | Change in A1c | 1 mmol/mol | Standard Deviation 0 |
Secondary
Cholesterol
Change in total cholesterol
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Cholesterol | 0.4 mmol/l | Standard Deviation 0 |
| High Carbohydrate Diet | Cholesterol | 0.2 mmol/l | Standard Deviation 0.3 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Coefficient of Variation of Glucose | 32.7 percentage | Standard Deviation 3.2 |
| High Carbohydrate Diet | Coefficient of Variation of Glucose | 37.5 percentage | Standard Deviation 3.6 |
Secondary
Creatinine
Change in creatinine
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Creatinine | 2 micromol/l | Standard Deviation 1 |
| High Carbohydrate Diet | Creatinine | 2 micromol/l | Standard Deviation 1 |
Secondary
CRP
Change in CRP
Time frame: 12 weeks - from baseline to end of study
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Diabetes Treatment Satisfaction | 3.8 units on a scale | Standard Deviation 2.7 |
| High Carbohydrate Diet | Diabetes Treatment Satisfaction | 4.9 units on a scale | Standard Deviation 4.6 |
Secondary
Diastolic Blood Pressure
Change in diastolic blood pressure
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Diastolic Blood Pressure | 2 mmHg | Standard Deviation 4 |
| High Carbohydrate Diet | Diastolic Blood Pressure | 7 mmHg | Standard Deviation 4 |
Secondary
Ferritin
Change in ferritin
Time frame: 12 weeks - from baseline to end of study
Secondary
Folate
Change in folate
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Folate | 0.5 micromol/l | Standard Deviation 0.1 |
| High Carbohydrate Diet | Folate | 0.3 micromol/l | Standard Deviation 0.9 |
Secondary
Free Fatty Acids
Change in free fatty acids
Time frame: 12 weeks - from baseline to end of study
Secondary
HDL
Change in HDL
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | HDL | 0.6 mmol/l | Standard Deviation 0 |
| High Carbohydrate Diet | HDL | 0.03 mmol/l | Standard Deviation 0.05 |
Secondary
Heart Rate
Change in heart rate
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Heart Rate | 3 beats per minute | Standard Deviation 0 |
| High Carbohydrate Diet | Heart Rate | 1 beats per minute | Standard Deviation 1 |
Secondary
Hemoglobin
Change in hemoglobin
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Hemoglobin | 0.3 mmol/l | Standard Deviation 0.1 |
| High Carbohydrate Diet | Hemoglobin | 0.2 mmol/l | Standard Deviation 0 |
Secondary
Hip Circumference
Change in hip circumference
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Hip Circumference | 5.2 centimeter | Standard Deviation 10.8 |
| High Carbohydrate Diet | Hip Circumference | 4.6 centimeter | Standard Deviation 0.4 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Hypoglycemia Fear | 0 units on a scale | Standard Deviation 0.9 |
| High Carbohydrate Diet | Hypoglycemia Fear | 2.5 units on a scale | Standard Deviation 6 |
Secondary
IL-1
Change in IL-1
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | IL-1 | 0.2 pg/ml | Standard Deviation 0.3 |
| High Carbohydrate Diet | IL-1 | 0.9 pg/ml | Standard Deviation 1.1 |
Secondary
IL-6
Change in IL-6
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | IL-6 | 1.8 pg/ml | Standard Deviation 7.1 |
| High Carbohydrate Diet | IL-6 | 6.5 pg/ml | Standard Deviation 4.3 |
Secondary
IL-8
Change in IL-8
Time frame: 12 weeks - from baseline to end of study
Secondary
Iron
Change in iron
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Iron | 2 micromol/l | Standard Deviation 4 |
| High Carbohydrate Diet | Iron | 4 micromol/l | Standard Deviation 0 |
Secondary
LDL
Change in LDL
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | LDL | 0.2 mmol/l | Standard Deviation 0 |
| High Carbohydrate Diet | LDL | 0.2 mmol/l | Standard Deviation 0.2 |
Secondary
Leucocytes
Change in leucocytes
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Leucocytes | 0.1 cells/l | Standard Deviation 0.2 |
| High Carbohydrate Diet | Leucocytes | 0.2 cells/l | Standard Deviation 0.1 |
Secondary
Magnesium
Change in magnesium
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Magnesium | 0.03 mmol/l | Standard Deviation 0 |
| High Carbohydrate Diet | Magnesium | 0.02 mmol/l | Standard Deviation 0 |
Secondary
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
Population: CGM data were collected, but the calculation of MAGE was not conducted. The analysis plan was changed as a result of changes in the guidelines for reporting of CGM-based measures. To calculate MAGE would require extensive work, and the results would be of no clinical relevance. Funding aquired for this project covers only clinically relevant analysis and ultimately, MAGE was not calculated due to lack of funding.
Secondary
Mean Glucose
Mean glucose value assessed by continuous glucose monitoring
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Mean Glucose | 8.8 mmol/l | Standard Deviation 0.7 |
| High Carbohydrate Diet | Mean Glucose | 8.9 mmol/l | Standard Deviation 0.7 |
Secondary
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
Population: Data cannot be reported because the data collection method was invalid.
Secondary
Potassium
Change in potassium
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Potassium | 0.2 mmol/l | Standard Deviation 0 |
| High Carbohydrate Diet | Potassium | 0.1 mmol/l | Standard Deviation 0.1 |
Secondary
Severe Hypoglycemia
Number of severe hypoglycemia episodes (glucagon or intravenous glucose administration)
Time frame: From baseline to 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Carbohydrate Diet | Severe Hypoglycemia | 0 events |
| High Carbohydrate Diet | Severe Hypoglycemia | 0 events |
Secondary
Sodium
Change in sodium
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Sodium | 0 mmol/l | Standard Deviation 1 |
| High Carbohydrate Diet | Sodium | 1 mmol/l | Standard Deviation 1 |
Secondary
Standard Deviation of Glucose
Standard deviation of glucose values assessed by continuous glucose monitoring
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Standard Deviation of Glucose | 2.9 mmol/l | Standard Deviation 0.4 |
| High Carbohydrate Diet | Standard Deviation of Glucose | 3.3 mmol/l | Standard Deviation 0.4 |
Secondary
Supar
Change in Supar
Time frame: 12 weeks - from baseline to end of study
Secondary
Systolic Blood Pressure
Change in systolic blood pressure
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Systolic Blood Pressure | 4 mmHg | Standard Deviation 1 |
| High Carbohydrate Diet | Systolic Blood Pressure | 12 mmHg | Standard Deviation 5 |
Secondary
Thrombocytes
Change in thrombocytes
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Thrombocytes | 17 cells/l | Standard Deviation 1 |
| High Carbohydrate Diet | Thrombocytes | 6 cells/l | Standard Deviation 10 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Time Spent in Hyperglycemia | 29.5 Percentage of time | Standard Deviation 9 |
| High Carbohydrate Diet | Time Spent in Hyperglycemia | 31.1 Percentage of time | Standard Deviation 7.3 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Time Spent in Hypoglycemia | 1.9 Percentage of time | Standard Deviation 1.8 |
| High Carbohydrate Diet | Time Spent in Hypoglycemia | 3.6 Percentage of time | Standard Deviation 2.1 |
Secondary
TNF-alpha
Change in TNF-alpha
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | TNF-alpha | 2.3 pg/ml | Standard Deviation 3 |
| High Carbohydrate Diet | TNF-alpha | 2.8 pg/ml | Standard Deviation 2.6 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Total Daily Basal Insulin 24 Hour | 18.5 Units of insulin | Standard Deviation 5.4 |
| High Carbohydrate Diet | Total Daily Basal Insulin 24 Hour | 17.3 Units of insulin | Standard Deviation 5.4 |
Secondary
Total Daily Bolus Insulin
Difference in total daily bolus insulin
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Total Daily Bolus Insulin | 15.1 Units of insulin | Standard Deviation 4.4 |
| High Carbohydrate Diet | Total Daily Bolus Insulin | 25.9 Units of insulin | Standard Deviation 7.3 |
Secondary
Total Daily Dose
Total daily insulin dose
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Total Daily Dose | 33.6 Units of insulin | Standard Deviation 8.1 |
| High Carbohydrate Diet | Total Daily Dose | 43.2 Units of insulin | Standard Deviation 11 |
Secondary
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
Secondary
Total Nightime Basal Insulin
Total nighttime basal insulin in the time range 00:00-06:00
Time frame: From baseline to 12 weeks
Secondary
Transferrin
Change in transferrin
Time frame: 12 weeks - from baseline to end of study
Secondary
Triglycerides
Change in triglycerides
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Triglycerides | 0.0 mmol/l | Standard Deviation 0.1 |
| High Carbohydrate Diet | Triglycerides | 0.1 mmol/l | Standard Deviation 0 |
Secondary
U-alb-crea Ratio
Change in urine albumin-creatinine ratio
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | U-alb-crea Ratio | 1 mg/mmol | Standard Deviation 4 |
| High Carbohydrate Diet | U-alb-crea Ratio | 3 mg/mmol | Standard Deviation 1 |
Secondary
Urate
Change in urate
Time frame: 12 weeks - from baseline to end of study
Secondary
Vitamin B-12
Change in vitamin B-12
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Vitamin B-12 | 18 pmol/l | Standard Deviation 8 |
| High Carbohydrate Diet | Vitamin B-12 | 35 pmol/l | Standard Deviation 10 |
Secondary
Waist Circumference
Change in waist circumference
Time frame: From baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Waist Circumference | -1.9 centimeter | Standard Deviation 0.5 |
| High Carbohydrate Diet | Waist Circumference | 0.0 centimeter | Standard Deviation 1.8 |
Secondary
Weight
Change in weight
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Weight | 1.9 kilogram | Standard Deviation 0.3 |
| High Carbohydrate Diet | Weight | 1.7 kilogram | Standard Deviation 1.6 |
Secondary
Zinc
Change in zinc
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Zinc | 1 micromol/l | Standard Deviation 1 |
| High Carbohydrate Diet | Zinc | 0 micromol/l | Standard Deviation 1 |
Other Pre-specified
Carbohydrate Intake
Daily carbohydrate intake assessed by insulin pump download
Time frame: 12 weeks - from baseline to end of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Carbohydrate Intake | 98 grams per day | Standard Deviation 11 |
| High Carbohydrate Diet | Carbohydrate Intake | 246 grams per day | Standard Deviation 34 |
Other Pre-specified
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Carbohydrate Diet | Ketones | 0.2 mmol/l | Standard Deviation 0.1 |
| High Carbohydrate Diet | Ketones | 0.1 mmol/l | Standard Deviation 0 |