Trials / Completed
CompletedNCT03997409
Impact of a Low-Carbohydrate Diet in Pediatric Type 1 Diabetes
Impact of a Low-Carbohydrate Diet on Glycemic Control and Lipids in Pediatric Type 1 Diabetes
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Vanderbilt University Medical Center · Academic / Other
- Sex
- All
- Age
- 13 Years – 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-11-18
- Primary completion
- 2021-06-30
- Completion
- 2021-06-30
- First posted
- 2019-06-25
- Last updated
- 2023-05-08
- Results posted
- 2023-05-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03997409. Inclusion in this directory is not an endorsement.