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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DK128560-01 | U.S. NIH Grant/Contract | View source | |
| 2P30DK045735-26 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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As more adolescents with type 1 diabetes (T1D) opt to follow very low carbohydrate diets to improve glucose control, it is becoming increasingly important to study the metabolic and neurological changes that occur on these diets and how these effect patient safety. Understanding the impact of dietary changes on metabolic and neurological factors will help guide clinical advice about the overall safety and efficacy of these diets in the pediatric T1D population. This work will be the basis of future studies testing dietary interventions to improve glycemic control and ensure that these dietary interventions are safe for growing youth with T1D.
The primary objective of this randomized crossover study is to determine whether a very low carbohydrate diet improves glycemic changes (measured by continuous glucose monitors) when compared to a standard carbohydrate diet in youth with type 1 diabetes.
The secondary objectives of the study are to compare metabolic changes after 2 weeks on each diet using the 2-step hyperinsulinemic euglycemic-hypoglycemic clamp and stable isotope infusions. The euglycemic portion of the clamp will allow us to determine the hepatic glucose production and adipose tissue lipolysis. Secondary objectives also include measuring the neurohormonal response to hypoglycemia after 2 weeks on each diet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low carbohydrate diet | Experimental | In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the low carbohydrate group will limit carbohydrate intake to 15% of total daily calories. |
|
| standard carbohydrate diet | Active Comparator | In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the standard carbohydrate group will follow an ad libitum diet with standard carbohydrate intake. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low carbohydrate diet | Other | Participants will engage in a diet that limits carbohydrate intake to 15% of total daily calories for 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Time in the Optimal Glucose Range | Time in the optimal glucose range will be operationally defined as the percent time spent in the target range of 70-180 mg/dL during the 2 weeks. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Time Spent With Hypoglycemia. | Time spent with hypoglycemia will be operationally defined as the percent time spent in the hypoglycemic ranges during 2 weeks of diet. Level 2 hypoglycemia defined as <54 mg/dL. Level 1 hypoglycemia defined as 54-69 mg/dL. | 2 weeks |
| Percent Time Spent With Hyperglycemia |
| Measure | Description | Time Frame |
|---|---|---|
| Human Factors | To describe how participants feel about and react to following a very low carbohydrate diet, interviews will be conducted. Data will be coded and emerging patterns will be combined into descriptive themes. | 8 weeeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura M Nally, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale-New Haven Hospital | New Haven | Connecticut | 06511 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Carbohydrate Diet, Then Standard Carbohydrate Diet | In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the low carbohydrate group will limit carbohydrate intake to 15% of total daily calories. low carbohydrate diet: Participants will engage in a diet that limits carbohydrate intake to 15% of total daily calories for 2 weeks. |
| FG001 | Standard Carbohydrate Diet, Then Low Carbohydrate Diet | In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the standard carbohydrate group will follow an ad libitum diet with standard carbohydrate intake. standard carbohydrate diet: Participants will engage in a diet that recommends standard carbohydrate intake with respect to total daily calories for 2 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Washout |
| |||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Carbohydrate Diet, Then Standard Carbohydrate Diet | In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the low carbohydrate group will limit carbohydrate intake to 15% of total daily calories. low carbohydrate diet: Participants will engage in a diet that limits carbohydrate intake to 15% of total daily calories for 2 weeks. |
| 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 | Percent Time in the Optimal Glucose Range | Time in the optimal glucose range will be operationally defined as the percent time spent in the target range of 70-180 mg/dL during the 2 weeks. | Posted | Mean | 95% Confidence Interval | percentage of time | 2 weeks |
|
8 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 | low carbohydrate diet: Participants will engage in a diet that limits carbohydrate intake to 15% of total daily calories for 2 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea/Vomiting with elevated ketone levels | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Nally | Yale school of Medicine | 203-785-5831 | laura.nally@yale.edu |
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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 | Aug 21, 2023 | Aug 26, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 12, 2023 | Aug 26, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| standard carbohydrate diet | Other | Participants will engage in a diet that recommends standard carbohydrate intake with respect to total daily calories for 2 weeks. |
|
Time spent with hyperglycemia will be operationally defined as the percent time spent in the hyperglycemic ranges during 2 weeks of diet. Level 1 hyperglycemia defined as 181-250 mg/dL. Level 2 hyperglycemia defined as >250 mg/dL. |
| 2 weeks |
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | Standard Carbohydrate Diet, Then Low Carbohydrate Diet | In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the standard carbohydrate group will follow an ad libitum diet with standard carbohydrate intake. standard carbohydrate diet: Participants will engage in a diet that recommends standard carbohydrate intake with respect to total daily calories for 2 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Percent Time Spent With Hypoglycemia. | Time spent with hypoglycemia will be operationally defined as the percent time spent in the hypoglycemic ranges during 2 weeks of diet. Level 2 hypoglycemia defined as <54 mg/dL. Level 1 hypoglycemia defined as 54-69 mg/dL. | Posted | Mean | 95% Confidence Interval | percentage of time | 2 weeks |
|
|
|
|
| Secondary | Percent Time Spent With Hyperglycemia | Time spent with hyperglycemia will be operationally defined as the percent time spent in the hyperglycemic ranges during 2 weeks of diet. Level 1 hyperglycemia defined as 181-250 mg/dL. Level 2 hyperglycemia defined as >250 mg/dL. | Posted | Mean | 95% Confidence Interval | percentage of time | 2 weeks |
|
|
|
|
| Other Pre-specified | Human Factors | To describe how participants feel about and react to following a very low carbohydrate diet, interviews will be conducted. Data will be coded and emerging patterns will be combined into descriptive themes. | Not Posted | 8 weeeks | Participants |
| 0 |
| 19 |
| 0 |
| 19 |
| 8 |
| 19 |
| EG001 | Standard Carbohydrate Diet | standard carbohydrate diet: Participants will engage in a diet that recommends standard carbohydrate intake with respect to total daily calories for 2 weeks. | 0 | 19 | 0 | 19 | 8 | 19 |
| EG002 | Washout Period | Washout period between the 2 diets | 0 | 19 | 0 | 19 | 1 | 19 |
| Elevated ketone levels without symptoms | General disorders | Systematic Assessment |
|
| Infusion site failure with elevated ketones | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Infusion site failure with hyperglycemia | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | Systematic Assessment |
|
| Pain at intravenous site | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Viral illness with vomiting | General disorders | Systematic Assessment |
|
| Hypoglycemia during clamp | Endocrine disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Allergic reaction to cough syrup | General disorders | Systematic Assessment |
|
| ER visit for foot pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Allergic reaction to fitness tracker wrist band | General disorders | Systematic Assessment |
|
| ER visit for foot injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| 0.43 |
| Superiority |
| <0.001 |
| Superiority |