Clinical trial NCT05498688: The Acute Effect of Low-carb Diet on the Plasma Fatty Acid Composition in Type 2 Diabetes
Official title: The Acute Effect of a Low-carbohydrate Meal on the Plasma Fatty Acid Composition in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Low carbohydrate diet
LCD
Plasma FA composition
Free fatty acids
Cardiovascular disease
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
First posted: 2022-08-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Plasma fatty acid composition
timeFrame: 5 hours
Secondary outcomes:
measure: Plasma glucose
timeFrame: 5 hours
measure: Serum insulin
timeFrame: 5 hours
measure: Plasma ketones
timeFrame: 5 hours
measure: Plasma free fatty acid
timeFrame: 5 hours
measure: Total cholesterol
timeFrame: 5 hours
measure: LDL cholesterol
timeFrame: 5 hours
measure: HDL cholesterol
timeFrame: 5 hours
measure: Triglycerides
timeFrame: 5 hours
measure: Other lipoprotein fractions
timeFrame: 5 hours
measure: Glucagon Like Peptide 1 (GLP1)
timeFrame: 5 hours
measure: Glucose-Dependent Insulinotropic Polypeptide (GIP)
timeFrame: 5 hours
measure: Cholecystokinin (CCK)
timeFrame: 5 hours
measure: Peptide YY (PYY)
timeFrame: 5 hours
measure: Ghrelin
timeFrame: 5 hours
measure: Subjective appetite
timeFrame: 5 hours
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Kurt Højlund, MD
role: PRINCIPAL_INVESTIGATOR
References: