Trials / Unknown
UnknownNCT05498688
The Acute Effect of Low-carb Diet on the Plasma Fatty Acid Composition in Type 2 Diabetes
The Acute Effect of a Low-carbohydrate Meal on the Plasma Fatty Acid Composition in Patients With Type 2 Diabetes
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- Sponsor
- Odense University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The investigators wishes to investigate the acute effect of a low carbohydrate meal on the plasma fatty acid (FA) composition compared with a control meal in a cross-over study of patients with type 2 diabetes (T2D). In two trial days 12 participants with T2D will either have a low carbohydrate meal or control meal, measurements will be performed at baseline and continuously over 5 hours.
Detailed description
Type 2 diabetes (T2D) is the most common metabolic disorder worldwide, and with an increasing prevalence T2D has become a major healthcare burden. Low carbohydrate diet (LCD) has become increasingly popular as a method of improving glycemic control in patients with type 2 diabetes. However, the higher content of especially saturated fat in LCD has raised concerns about harmful effects. A previous study has shown increase in non esterified fatty acids after a low carbohydrate meal, but it still needs to be investigated how a low carbohydrate meal affects the plasma FA composition. The aim of this project is to investigate the hypothesis that a single low carbohydrate meal results in an improved plasma FA composition in patients with T2D and that this, at least in part, corresponds to the changes observed after 6 months LCD. The study will be conducted as a cross-over trial with 12 participants with T2D. The participants will randomly be assigned to either start with the low carbohydrate meal or a control meal with a 2 weeks washout period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Low carbohydrate | Participants will have a low carbohydrate meal |
Timeline
- Start date
- 2022-08-25
- Primary completion
- 2022-12-01
- Completion
- 2022-12-01
- First posted
- 2022-08-12
- Last updated
- 2022-09-07
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT05498688. Inclusion in this directory is not an endorsement.