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

Type 2 Diabetes Clinical Trial

Official title:

The Acute Effect of a Low-carbohydrate Meal on the Plasma Fatty Acid Composition in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05498688
• Other study ID #: S-20220003
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2022
• Est. completion date: December 2022

Study information

• Verified date: September 2022
• Source: Odense University Hospital
• Contact: Kurt Højlund, MD
• Phone: +45 25320648
• Email: kurt.hoejlund[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Low carbohydrate
Participants will have a low carbohydrate meal

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Odense University Hospital	Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma fatty acid composition	Quantified as weight percentage (wt%) of total plasma phospholipid FA	5 hours
Secondary	Plasma glucose		5 hours
Secondary	Serum insulin		5 hours
Secondary	Plasma ketones		5 hours
Secondary	Plasma free fatty acid		5 hours
Secondary	Total cholesterol		5 hours
Secondary	LDL cholesterol		5 hours
Secondary	HDL cholesterol		5 hours
Secondary	Triglycerides		5 hours
Secondary	Other lipoprotein fractions		5 hours
Secondary	Glucagon Like Peptide 1 (GLP1)		5 hours
Secondary	Glucose-Dependent Insulinotropic Polypeptide (GIP)		5 hours
Secondary	Cholecystokinin (CCK)		5 hours
Secondary	Peptide YY (PYY)		5 hours
Secondary	Ghrelin		5 hours
Secondary	Subjective appetite	Visual analog scale - mm. 0 mm - 100 mm. 0 mm = none and 100 mm = very strong	5 hours