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

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: Low carbohydrate

• Registration Number: NCT05498688
• Lead Sponsor: Odense University Hospital

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 Timeline

• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-08-10
• Study First Posted: 2022-08-12
• Study Start: 2022-08-25
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-01
• Last Update Posted: 2022-09-07
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Plasma fatty acid composition	5 hours	Quantified as weight percentage (wt%) of total plasma phospholipid FA

Secondary Outcome Measures

Name	Time	Method
Glucose-Dependent Insulinotropic Polypeptide (GIP)	5 hours
Subjective appetite	5 hours	Visual analog scale - mm. 0 mm - 100 mm. 0 mm = none and 100 mm = very strong
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
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

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark