Type 2 Diabetes
Conditions
Keywords
Low carbohydrate diet, LCD, Plasma FA composition, Free fatty acids, Cardiovascular disease
Brief 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.
Interventions
DIETARY_SUPPLEMENTLow carbohydrate
Participants will have a low carbohydrate meal
Sponsors
Aalborg University Hospital
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Duration of established type 2 diabetes for more than six months and less than five years, but duration of type 2 diabetes for up to 10 years if the current treatment consists of ≤ 2 oral antidiabetic drugs without insulin. 2. HbA1c in compliance with type 2 diabetes (above 48 mmol/mol), with or without use of glucose-lowering pharmacotherapy, but without need for adjustment of antidiabetic treatment. 3. Stable antidiabetic treatment three months prior to inclusion. 4. Well treated dyslipidemia (LDL cholesterol \< 2.5 mmol/l and total cholesterol \< 4.5 mmol/l at inclusion) with or without statins. 5. BMI ≥ 25. 6. Age ≥ 18 years. 7. All participants have to understand oral and written Danish. 8. All participants have to sign an informed consent after oral and written information on experimental design.
Exclusion criteria
1. Significant comorbidity, including liver disease. 2. A history of cancer \< 5 years or current chemotherapy. 3. Other severe co-morbidity that could interfere with study compliance or safety (e.g. previous gastrointestinal operations, liver disease, history of eating disorder, current alcohol overuse or hypoglycemic unawareness). 4. Current treatment with glucocorticoids (systemic). 5. Continuous treatment with steatosis-inducing drugs. 6. Treatment with antibiotics during the last two months before inclusion. 7. Low-carbohydrate diet prior to inclusion, or other restrictive diet. 8. Weight-loss \> 10 kg over the last three months before inclusion. 9. Pregnancy or expected pregnancy within the next 6 months. 10. Elevated blood pressure (180/110) with or without antihypertensives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma fatty acid composition | 5 hours | Quantified as weight percentage (wt%) of total plasma phospholipid FA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum insulin | 5 hours | — |
| Plasma ketones | 5 hours | — |
| Plasma free fatty acid | 5 hours | — |
| Total cholesterol | 5 hours | — |
| LDL cholesterol | 5 hours | — |
| HDL cholesterol | 5 hours | — |
| Triglycerides | 5 hours | — |
| Plasma glucose | 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 | 5 hours | Visual analog scale - mm. 0 mm - 100 mm. 0 mm = none and 100 mm = very strong |
| Other lipoprotein fractions | 5 hours | — |
Countries
Denmark
Contacts
Primary ContactKurt Højlund, MD
Backup ContactJulie Rasmussen
Outcome results
None listed