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出境医 / 临床实验 / Impact of a Low-Carbohydrate Diet in Pediatric Type 1 Diabetes
Impact of a Low-Carbohydrate Diet in Pediatric Type 1 Diabetes
Study Description
Brief Summary:
Dietary carbohydrate consumption is a key factor influencing postprandial glycemia for patients with type 1 diabetes mellitus (T1DM). Because post-prandial glucose excursions profoundly influence hemoglobin A1c (HbA1c), therapeutic approaches to mitigate post-prandial hyperglycemia are of great importance. The quantity and source of carbohydrates affect post-prandial glycemia more than any other dietary factor. These findings serve as the physiologic basis for a growing interest in carbohydrate-restricted diets in the management of T1DM despite American Diabetes Association (ADA) guidelines that discourage restricting total carbohydrate intake to less than 130 grams per day. Although case series and prospective studies suggest low-carbohydrate diets (LCD) significantly improve HbA1c for adults with T1DM, data in the pediatric T1DM population is limited. The investigators will conduct a randomized prospective pilot study evaluating glycemic control, lipidemia, and quality of life (QOL) in pediatric T1DM patients on a LCD.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Type 1 Diabetes | Other: Dietary Intervention | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 45 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Care Provider) |
| Primary Purpose: | Treatment |
| Official Title: | Impact of a Low-Carbohydrate Diet on Glycemic Control and Lipids in Pediatric Type 1 Diabetes |
| Actual Study Start Date : | November 18, 2019 |
| Estimated Primary Completion Date : | July 2021 |
| Estimated Study Completion Date : | July 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Low Carbohydrate Diet
The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine. Participants on the LCD intervention will consume 25-35% of total daily intake from carbohydrates, 45-65% from fat and 10-30% from protein.
|
Other: Dietary Intervention
The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.
|
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Active Comparator: Standard Carbohydrate Diet
The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine. Participants on the SCD intervention will consume 45-65% of total daily caloric intake from carbohydrates, 25-35% from fat and 10-30% from protein.
|
Other: Dietary Intervention
The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.
|
|
No Intervention: No Dietary Recommendations
This group will serve as a control that receives the same number of education sessions as LCD and SCD group to teach general diabetes management but without specific dietary recommendations.
|
Outcome Measures
Primary Outcome Measures :
- HbA1c [ Time Frame: 12 weeks ]HbA1c (%) change from baseline to 12 weeks will be compared between the groups
Secondary Outcome Measures :
- Percent of time spent in the glycemic target of 70 - 140 mg/dL [ Time Frame: 12 weeks ]Obtained from continuous glucose monitor data
- Percent of time spent above the glycemic target of 140 mg/dL [ Time Frame: 12 weeks ]Obtained from continuous glucose monitor data
- Percent of time spent below the glycemic target of 70 mg/dL [ Time Frame: 12 weeks ]Obtained from continuous glucose monitor data
- Percent of time spent in hypoglycemia below 50 mg/dL [ Time Frame: 12 weeks ]Obtained from continuous glucose monitor data
- Average blood glucose [ Time Frame: 12 weeks ]Change in average blood glucose (calculated from continuous glucose monitoring data) from baseline to 12 weeks will be compared between groups
- Blood glucose standard variation [ Time Frame: 12 weeks ]Change in the blood glucose standard deviation (obtained from continuous glucose monitor data) from baseline to 12 weeks will be compared between groups
- Average total daily dose of insulin [ Time Frame: 12 weeks ]Insulin pump data
- Average bolus amount of insulin per day [ Time Frame: 12 weeks ]Insulin pump data
- Average basal amount of insulin per day [ Time Frame: 12 weeks ]Insulin pump data
- Low density lipoprotein particle number [ Time Frame: Weeks 0 and 12 ]NMR spectroscopy lipoprofile
- High density lipoprotein particle number [ Time Frame: Weeks 0 and 12 ]NMR spectroscopy lipoprofile
- Small low density lipoprotein particle number [ Time Frame: Weeks 0 and 12 ]NMR spectroscopy lipoprofile
- Low density lipoprotein size [ Time Frame: Weeks 0 and 12 ]NMR spectroscopy lipoprofile
- Beta-hydroxybutyrate [ Time Frame: Weeks 0 and 12 ]Change in concentration of serum ketones (beta-hydroxybutyrate) from baseline to 12 weeks will be compared between groups
- Pediatric Quality of Life Inventory (PedsQL) Diabetes Module [ Time Frame: Weeks 0 and 12 ]Quality of Life Measure (score 0 - 100 with higher scores indicating higher QOL)
- Problem Areas in Diabetes: Teen Version (PAID-T) [ Time Frame: Weeks 0 and 12 ]Diabetes distress measure (score 0 - 156 with higher scores indicating increased distress)
Eligibility Criteria
| Ages Eligible for Study: | 13 Years to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosed with T1DM for at least 12 months
- Age 13 to 21 years
- Total daily dose of insulin 0.5 to 1.25 units/kg/day
- Current use of an insulin pump and CGM
- HbA1c between 7% and 10%
- Tanner stage 3 to 5 on physical exam
- Participant or parent of participant use of smart phone
- Able to read and speak English
Exclusion Criteria:
- Any episode of diabetic ketoacidosis (DKA) in the last 12 months
- Any episode of severe hypoglycemia (defined as requiring assistance from another person, including coma, seizures, or episodes requiring glucagon, IV dextrose or oral carbohydrate administered by another person) in the last 12 months
- Any prior abnormal fasting lipid panel (LDL > 130)
- Additional dietary restrictions
- Following a weight-loss or otherwise restrictive diet
- Use of medication or supplements other than insulin to control blood glucose
- Use of medication or other supplements to lower lipids
- Pregnancy or breast feeding
- History of hemoglobinopathy
Contacts and Locations
Contacts
| Contact: Sara H Duffus, MD | 615-875-3269 | sara.duffus@vumc.org | |
| Contact: Justin M Gregory, MD, MSCI | 615-322-7424 | justin.m.gregory.1@vumc.org |
Locations
| United States, Tennessee | |
| Vanderbilt University Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37212 | |
| Contact: Sara H Duffus, MD 615-875-3269 sara.duffus@vumc.org | |
| Contact: Justin M Gregory, MD 615-322-7427 justin.m.gregory.1@vumc.org | |
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
| Study Director: | Justin M Gregory, MD, MSCI | Vanderbilt University Medical Center |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 21, 2019 | ||||||||
| First Posted Date ICMJE | June 25, 2019 | ||||||||
| Last Update Posted Date | December 17, 2020 | ||||||||
| Actual Study Start Date ICMJE | November 18, 2019 | ||||||||
| Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
HbA1c [ Time Frame: 12 weeks ] HbA1c (%) change from baseline to 12 weeks will be compared between the groups
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| Original Primary Outcome Measures ICMJE |
HbA1c [ Time Frame: 12 weeks ] Change in HbA1c from baseline to 12 weeks
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Impact of a Low-Carbohydrate Diet in Pediatric Type 1 Diabetes | ||||||||
| Official Title ICMJE | Impact of a Low-Carbohydrate Diet on Glycemic Control and Lipids in Pediatric Type 1 Diabetes | ||||||||
| Brief Summary | Dietary carbohydrate consumption is a key factor influencing postprandial glycemia for patients with type 1 diabetes mellitus (T1DM). Because post-prandial glucose excursions profoundly influence hemoglobin A1c (HbA1c), therapeutic approaches to mitigate post-prandial hyperglycemia are of great importance. The quantity and source of carbohydrates affect post-prandial glycemia more than any other dietary factor. These findings serve as the physiologic basis for a growing interest in carbohydrate-restricted diets in the management of T1DM despite American Diabetes Association (ADA) guidelines that discourage restricting total carbohydrate intake to less than 130 grams per day. Although case series and prospective studies suggest low-carbohydrate diets (LCD) significantly improve HbA1c for adults with T1DM, data in the pediatric T1DM population is limited. The investigators will conduct a randomized prospective pilot study evaluating glycemic control, lipidemia, and quality of life (QOL) in pediatric T1DM patients on a LCD. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Care Provider) Primary Purpose: Treatment |
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| Condition ICMJE | Type 1 Diabetes | ||||||||
| Intervention ICMJE | Other: Dietary Intervention
The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
45 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | July 2021 | ||||||||
| Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 13 Years to 21 Years (Child, Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03997409 | ||||||||
| Other Study ID Numbers ICMJE | 190851 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Sara Duffus, Vanderbilt University Medical Center | ||||||||
| Study Sponsor ICMJE | Vanderbilt University Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Vanderbilt University Medical Center | ||||||||
| Verification Date | December 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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