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| Name | Class |
|---|---|
| Aalborg University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low carbohydrate | Experimental | The intervention meal is a low-carbohydrate meal composed of 15 E% carbohydrates, 20 E% protein and 65 E% fat |
|
| Control meal | No Intervention | The control meal is a regular diabetes meal according to the official Danish dietary guidelines composed of 50 E% carbohydrates, 20 E% protein and 30 E% fat |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low carbohydrate | Dietary Supplement | Participants will have a low carbohydrate meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma fatty acid composition | Quantified as weight percentage (wt%) of total plasma phospholipid FA | 5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma glucose | 5 hours | |
| Serum insulin | 5 hours | |
| Plasma ketones |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kurt Højlund, MD | Contact | +45 25320648 | kurt.hoejlund@rsyd.dk | |
| Julie Rasmussen | Contact | juras17@student.sdu.dk |
| Name | Affiliation | Role |
|---|---|---|
| Kurt Højlund, MD | Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Recruiting | Odense | 5000 | Denmark |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 5 hours |
| Plasma free fatty acid | 5 hours |
| Total cholesterol | 5 hours |
| LDL cholesterol | 5 hours |
| HDL cholesterol | 5 hours |
| Triglycerides | 5 hours |
| Other lipoprotein fractions | 5 hours |
| Glucagon Like Peptide 1 (GLP1) | 5 hours |
| Glucose-Dependent Insulinotropic Polypeptide (GIP) | 5 hours |
| Cholecystokinin (CCK) | 5 hours |
| Peptide YY (PYY) | 5 hours |
| Ghrelin | 5 hours |
| Subjective appetite | Visual analog scale - mm. 0 mm - 100 mm. 0 mm = none and 100 mm = very strong | 5 hours |
| D004700 | Endocrine System Diseases |