The Acute Effect of Low-carb Diet on the Plasma Fatty Acid Composition in Type 2 Diabetes

Odense University Hospital

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Dietary Supplement: Low carbohydrate

Study type: Interventional

Funder types: Other

Identifiers

NCT05498688

S-20220003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Low carbohydrate

Experimental group

Description:

The intervention meal is a low-carbohydrate meal composed of 15 E% carbohydrates, 20 E% protein and 65 E% fat

Treatment:

Dietary Supplement: Low carbohydrate

Control meal

No Intervention group

Description:

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