The Acute Effect of a Low-carbohydrate Meal on the Plasma Fatty Acid Composition in Patients With Type 2 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Odense University Hospital
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Plasma fatty acid composition
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •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.
- •Stable antidiabetic treatment three months prior to inclusion.
- •Well treated dyslipidemia (LDL cholesterol < 2.5 mmol/l and total cholesterol < 4.5 mmol/l at inclusion) with or without statins.
- •Age ≥ 18 years.
- •All participants have to understand oral and written Danish.
- •All participants have to sign an informed consent after oral and written information on experimental design.
Exclusion Criteria
- •Significant comorbidity, including liver disease.
- •A history of cancer < 5 years or current chemotherapy.
- •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).
- •Current treatment with glucocorticoids (systemic).
- •Continuous treatment with steatosis-inducing drugs.
- •Treatment with antibiotics during the last two months before inclusion.
- •Low-carbohydrate diet prior to inclusion, or other restrictive diet.
- •Weight-loss > 10 kg over the last three months before inclusion.
- •Pregnancy or expected pregnancy within the next 6 months.
- •Elevated blood pressure (180/110) with or without antihypertensives.
Outcomes
Primary Outcomes
Plasma fatty acid composition
Time Frame: 5 hours
Quantified as weight percentage (wt%) of total plasma phospholipid FA
Secondary Outcomes
- Subjective appetite(5 hours)
- Plasma glucose(5 hours)
- Serum insulin(5 hours)
- Plasma free fatty acid(5 hours)
- LDL cholesterol(5 hours)
- Triglycerides(5 hours)
- Glucagon Like Peptide 1 (GLP1)(5 hours)
- HDL cholesterol(5 hours)
- Glucose-Dependent Insulinotropic Polypeptide (GIP)(5 hours)
- Peptide YY (PYY)(5 hours)
- Plasma ketones(5 hours)
- Total cholesterol(5 hours)
- Other lipoprotein fractions(5 hours)
- Cholecystokinin (CCK)(5 hours)
- Ghrelin(5 hours)
Investigators
Karina Vejrum Sørensen
Nutrition consultant
Odense University Hospital