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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Carbohydrate Diet | Experimental | < 100 grams of carbohydrate per day |
|
| High Carbohydrate Diet | Experimental | > 250 grams of carbohydrate per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low carbohydrate diet | Other |
| ||
| High carbohydrate diet |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time Spent in Euglycemia | Time spent with glucose values 4.0-10.0 mmol/l assessed by continuous glucose monitoring | 12 weeks - from baseline to end of study |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Glucose | Mean glucose value assessed by continuous glucose monitoring | 12 weeks - from baseline to end of study |
| Standard Deviation of Glucose | Standard deviation of glucose values assessed by continuous glucose monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| Carbohydrate Intake | Daily carbohydrate intake assessed by insulin pump download | 12 weeks - from baseline to end of study |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre University Hospital | Hvidovre | 2650 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30924570 | Result | 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. | |
| 33855222 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Carbohydrate Diet | < 100 grams of carbohydrate per day Low carbohydrate diet |
| FG001 | High Carbohydrate Diet | > 250 grams of carbohydrate per day High carbohydrate diet |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention Period |
| |||||||||||||
| Second Intervention Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Cohort | Baseline characteristics are for the whole study cohort, not for each of study arm of the cross-over study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Time Spent in Euglycemia | Time spent with glucose values 4.0-10.0 mmol/l assessed by continuous glucose monitoring | Posted | Mean | Standard Deviation | Percentage of time | 12 weeks - from baseline to end of study |
|
|
36 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Carbohydrate Diet | < 100 grams of carbohydrate per day Low carbohydrate diet |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic ketoacidosis | Endocrine disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Signe Schmidt | Steno Diabetes Center Copenhagen | +4551174785 | signe.schmidt@regionh.dk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2016 | Jul 28, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D000076107 | Diet, High-Protein Low-Carbohydrate |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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|
| 12 weeks - from baseline to end of study |
| Coefficient of Variation of Glucose | Coefficient of variation of glucose values assessed by continuous glucose monitoring | 12 weeks - from baseline to end of study |
| Mean Amplitude of Glycemic Excursions | Mean amplitude of glycemic excursions (MAGE) assessed by continuous glucose monitoring | 12 weeks - from baseline to end of study |
| Time Spent in Hypoglycemia | Percentage of time spent with glucose values ≤ 3.9 mmol/l assessed by continuous glucose monitoring | 12 weeks - from baseline to end of study |
| Time Spent in Hyperglycemia | Time spent with glucose values > 10.0 mmol/l assessed by continuous glucose monitoring | 12 weeks - from baseline to end of study |
| Change in A1c | Change in hemoglobin A1c | From baseline to 12 weeks |
| AUC Low | Difference in area under the curve <4.0 mmol/l assessed by continuous glucose monitoring | 12 weeks - from baseline to end of study |
| AUC High | Difference in area under the curve >10.0 mmol/l assessed by continuous glucose monitoring | 12 weeks - from baseline to end of study |
| Post Breakfast Glucose Excursion | Difference in post breakfast glucose excursion assessed by continuous glucose monitoring | 12 weeks - from baseline to end of study |
| Severe Hypoglycemia | Number of severe hypoglycemia episodes (glucagon or intravenous glucose administration) | From baseline to 12 weeks |
| Total Daily Dose | Total daily insulin dose | 12 weeks - from baseline to end of study |
| Total Daily Basal Insulin 24 Hour | Total daily basal insulin dose in the time range 00:00-24:00 | 12 weeks - from baseline to end of study |
| Total Nightime Basal Insulin | Total nighttime basal insulin in the time range 00:00-06:00 | From baseline to 12 weeks |
| Total Daytime Basal Insulin | Total daytime basal insulin in the time range 06:00-24:00 | 12 weeks - from baseline to end of study |
| Total Daily Bolus Insulin | Difference in total daily bolus insulin | 12 weeks - from baseline to end of study |
| Blood Glucose Readings | Number of blood glucose readings | 12 weeks - from baseline to end of study |
| Carbohydrate Servings | Number of daily carbohydrate servings (one serving ≥ 15 grams) | 12 weeks - from baseline to end of study |
| Body Composition | Change in fat mass (% of total body weight) assessed by Dual-energy X-ray Absorptiometry | 12 weeks - from baseline to end of study |
| Weight | Change in weight | 12 weeks - from baseline to end of study |
| Hip Circumference | Change in hip circumference | 12 weeks - from baseline to end of study |
| Waist Circumference | Change in waist circumference | From baseline to 12 weeks |
| Systolic Blood Pressure | Change in systolic blood pressure | 12 weeks - from baseline to end of study |
| Diastolic Blood Pressure | Change in diastolic blood pressure | 12 weeks - from baseline to end of study |
| Heart Rate | Change in heart rate | 12 weeks - from baseline to end of study |
| Diabetes Treatment Satisfaction | Change in Diabetes Treatment Satisfaction Questionnaire score. Score range: 0-36, with higher values representing higher degrees of treatment satisfaction. | 12 weeks - from baseline to end of study |
| Hypoglycemia Fear | Change in Hypoglycemia Fear Survey score. Score range: 0-52, with higher scores indicating higher degrees of fear of hypoglycemia. | 12 weeks - from baseline to end of study |
| Cholesterol | Change in total cholesterol | 12 weeks - from baseline to end of study |
| HDL | Change in HDL | 12 weeks - from baseline to end of study |
| LDL | Change in LDL | 12 weeks - from baseline to end of study |
| Triglycerides | Change in triglycerides | 12 weeks - from baseline to end of study |
| Free Fatty Acids | Change in free fatty acids | 12 weeks - from baseline to end of study |
| Sodium | Change in sodium | 12 weeks - from baseline to end of study |
| Potassium | Change in potassium | 12 weeks - from baseline to end of study |
| Creatinine | Change in creatinine | 12 weeks - from baseline to end of study |
| Urate | Change in urate | 12 weeks - from baseline to end of study |
| Albumin | Change in albumin | 12 weeks - from baseline to end of study |
| Hemoglobin | Change in hemoglobin | 12 weeks - from baseline to end of study |
| Leucocytes | Change in leucocytes | 12 weeks - from baseline to end of study |
| Thrombocytes | Change in thrombocytes | 12 weeks - from baseline to end of study |
| Iron | Change in iron | 12 weeks - from baseline to end of study |
| Transferrin | Change in transferrin | 12 weeks - from baseline to end of study |
| Ferritin | Change in ferritin | 12 weeks - from baseline to end of study |
| Folate | Change in folate | 12 weeks - from baseline to end of study |
| Vitamin B-12 | Change in vitamin B-12 | 12 weeks - from baseline to end of study |
| Magnesium | Change in magnesium | 12 weeks - from baseline to end of study |
| Zinc | Change in zinc | 12 weeks - from baseline to end of study |
| U-alb-crea Ratio | Change in urine albumin-creatinine ratio | 12 weeks - from baseline to end of study |
| Supar | Change in Supar | 12 weeks - from baseline to end of study |
| CRP | Change in CRP | 12 weeks - from baseline to end of study |
| IL-1 | Change in IL-1 | 12 weeks - from baseline to end of study |
| IL-6 | Change in IL-6 | 12 weeks - from baseline to end of study |
| IL-8 | Change in IL-8 | 12 weeks - from baseline to end of study |
| TNF-alpha | Change in TNF-alpha | 12 weeks - from baseline to end of study |
| Spot test at week 0, 2, 4, 6, 8, 10 and 12 |
| 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. |
| 33855215 | Derived | 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. |
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| body mass index | Median | Inter-Quartile Range | kg/m*m |
|
| diabetes duration | Median | Inter-Quartile Range | years |
|
| HbA1c | Median | Inter-Quartile Range | mmol/mol |
|
| insulin pump use | Median | Inter-Quartile Range | years |
|
| daily carbohydrate intake | Median | Inter-Quartile Range | grams |
|
| Participants |
|
|
| Secondary | Mean Glucose | Mean glucose value assessed by continuous glucose monitoring | Posted | Mean | Standard Deviation | mmol/l | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Standard Deviation of Glucose | Standard deviation of glucose values assessed by continuous glucose monitoring | Posted | Mean | Standard Deviation | mmol/l | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Coefficient of Variation of Glucose | Coefficient of variation of glucose values assessed by continuous glucose monitoring | Posted | Mean | Standard Deviation | percentage | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Mean Amplitude of Glycemic Excursions | Mean amplitude of glycemic excursions (MAGE) assessed by continuous glucose monitoring | 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. | Posted | 12 weeks - from baseline to end of study |
|
|
| Secondary | Time Spent in Hypoglycemia | Percentage of time spent with glucose values ≤ 3.9 mmol/l assessed by continuous glucose monitoring | Posted | Mean | Standard Deviation | Percentage of time | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Time Spent in Hyperglycemia | Time spent with glucose values > 10.0 mmol/l assessed by continuous glucose monitoring | Posted | Mean | Standard Deviation | Percentage of time | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Change in A1c | Change in hemoglobin A1c | Posted | Mean | Standard Deviation | mmol/mol | From baseline to 12 weeks |
|
|
|
| Secondary | AUC Low | Difference in area under the curve <4.0 mmol/l assessed by continuous glucose monitoring | 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. | Posted | 12 weeks - from baseline to end of study |
|
|
| Secondary | AUC High | Difference in area under the curve >10.0 mmol/l assessed by continuous glucose monitoring | 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. | Posted | 12 weeks - from baseline to end of study |
|
|
| Secondary | Post Breakfast Glucose Excursion | Difference in post breakfast glucose excursion assessed by continuous glucose monitoring | Data cannot be reported because the data collection method was invalid. | Posted | 12 weeks - from baseline to end of study |
|
|
| Secondary | Severe Hypoglycemia | Number of severe hypoglycemia episodes (glucagon or intravenous glucose administration) | Posted | Number | events | From baseline to 12 weeks |
|
|
|
| Secondary | Total Daily Dose | Total daily insulin dose | Posted | Mean | Standard Deviation | Units of insulin | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Total Daily Basal Insulin 24 Hour | Total daily basal insulin dose in the time range 00:00-24:00 | Posted | Mean | Standard Deviation | Units of insulin | 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 | Not Posted | Aug 2026 | From baseline to 12 weeks | Participants |
| Secondary | Total Daytime Basal Insulin | Total daytime basal insulin in the time range 06:00-24:00 | Not Posted | Aug 2026 | 12 weeks - from baseline to end of study | Participants |
| Secondary | Total Daily Bolus Insulin | Difference in total daily bolus insulin | Posted | Mean | Standard Deviation | Units of insulin | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Blood Glucose Readings | Number of blood glucose readings | Not Posted | Aug 2026 | 12 weeks - from baseline to end of study | Participants |
| Secondary | Carbohydrate Servings | Number of daily carbohydrate servings (one serving ≥ 15 grams) | Not Posted | Aug 2026 | 12 weeks - from baseline to end of study | Participants |
| Secondary | Body Composition | Change in fat mass (% of total body weight) assessed by Dual-energy X-ray Absorptiometry | Posted | Mean | Standard Deviation | percentage of total body weight | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Weight | Change in weight | Posted | Mean | Standard Deviation | kilogram | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Hip Circumference | Change in hip circumference | Posted | Mean | Standard Deviation | centimeter | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Waist Circumference | Change in waist circumference | Posted | Mean | Standard Deviation | centimeter | From baseline to 12 weeks |
|
|
|
| Secondary | Systolic Blood Pressure | Change in systolic blood pressure | Posted | Mean | Standard Deviation | mmHg | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Diastolic Blood Pressure | Change in diastolic blood pressure | Posted | Mean | Standard Deviation | mmHg | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Heart Rate | Change in heart rate | Posted | Mean | Standard Deviation | beats per minute | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Hypoglycemia Fear | Change in Hypoglycemia Fear Survey score. Score range: 0-52, with higher scores indicating higher degrees of fear of hypoglycemia. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Cholesterol | Change in total cholesterol | Posted | Mean | Standard Deviation | mmol/l | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | HDL | Change in HDL | Posted | Mean | Standard Deviation | mmol/l | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | LDL | Change in LDL | Posted | Mean | Standard Deviation | mmol/l | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Triglycerides | Change in triglycerides | Posted | Mean | Standard Deviation | mmol/l | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Free Fatty Acids | Change in free fatty acids | Not Posted | Aug 2026 | 12 weeks - from baseline to end of study | Participants |
| Secondary | Sodium | Change in sodium | Posted | Mean | Standard Deviation | mmol/l | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Potassium | Change in potassium | Posted | Mean | Standard Deviation | mmol/l | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Creatinine | Change in creatinine | Posted | Mean | Standard Deviation | micromol/l | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Urate | Change in urate | Not Posted | Aug 2026 | 12 weeks - from baseline to end of study | Participants |
| Secondary | Albumin | Change in albumin | Posted | Mean | Standard Deviation | g/l | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Hemoglobin | Change in hemoglobin | Posted | Mean | Standard Deviation | mmol/l | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Leucocytes | Change in leucocytes | Posted | Mean | Standard Deviation | cells/l | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Thrombocytes | Change in thrombocytes | Posted | Mean | Standard Deviation | cells/l | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Iron | Change in iron | Posted | Mean | Standard Deviation | micromol/l | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Transferrin | Change in transferrin | Not Posted | Aug 2026 | 12 weeks - from baseline to end of study | Participants |
| Secondary | Ferritin | Change in ferritin | Not Posted | Aug 2026 | 12 weeks - from baseline to end of study | Participants |
| Secondary | Folate | Change in folate | Posted | Mean | Standard Deviation | micromol/l | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Vitamin B-12 | Change in vitamin B-12 | Posted | Mean | Standard Deviation | pmol/l | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Magnesium | Change in magnesium | Posted | Mean | Standard Deviation | mmol/l | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Zinc | Change in zinc | Posted | Mean | Standard Deviation | micromol/l | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | U-alb-crea Ratio | Change in urine albumin-creatinine ratio | Posted | Mean | Standard Deviation | mg/mmol | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | Supar | Change in Supar | Not Posted | Aug 2026 | 12 weeks - from baseline to end of study | Participants |
| Secondary | CRP | Change in CRP | Not Posted | Aug 2026 | 12 weeks - from baseline to end of study | Participants |
| Secondary | IL-1 | Change in IL-1 | Posted | Mean | Standard Deviation | pg/ml | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | IL-6 | Change in IL-6 | Posted | Mean | Standard Deviation | pg/ml | 12 weeks - from baseline to end of study |
|
|
|
| Secondary | IL-8 | Change in IL-8 | Not Posted | Aug 2026 | 12 weeks - from baseline to end of study | Participants |
| Secondary | TNF-alpha | Change in TNF-alpha | Posted | Mean | Standard Deviation | pg/ml | 12 weeks - from baseline to end of study |
|
|
|
| Other Pre-specified | Carbohydrate Intake | Daily carbohydrate intake assessed by insulin pump download | Posted | Mean | Standard Deviation | grams per day | 12 weeks - from baseline to end of study |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mmol/l | Spot test at week 0, 2, 4, 6, 8, 10 and 12 |
|
|
|
| 0 |
| 14 |
| 1 |
| 14 |
| 0 |
| 14 |
| EG001 | High Carbohydrate Diet | > 250 grams of carbohydrate per day High carbohydrate diet | 0 | 12 | 0 | 12 | 0 | 12 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D000073600 | Diet, High-Protein |