The Acute Effect of Low-carb Diet on the Plasma Fatty Acid Composition in Type 2 Diabetes
NCT ID: NCT05498688
Last Updated: 2022-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
12 participants
INTERVENTIONAL
2022-08-25
2022-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Low carbohydrate
The intervention meal is a low-carbohydrate meal composed of 15 E% carbohydrates, 20 E% protein and 65 E% fat
Low carbohydrate
Participants will have a low carbohydrate meal
Control meal
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
No interventions assigned to this group
Interventions
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Low carbohydrate
Participants will have a low carbohydrate meal
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Aalborg University Hospital
OTHER
Odense University Hospital
OTHER
Responsible Party
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Karina Vejrum Sørensen
Nutrition consultant
Principal Investigators
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Kurt Højlund, MD
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Locations
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Odense University Hospital
Odense, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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S-20220003
Identifier Type: -
Identifier Source: org_study_id
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