search
Back to results

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

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Low carbohydrate
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Low carbohydrate diet, LCD, Plasma FA composition, Free fatty acids, Cardiovascular disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Odense University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Low carbohydrate

Control meal

Arm Description

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

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

Outcomes

Primary Outcome Measures

Plasma fatty acid composition
Quantified as weight percentage (wt%) of total plasma phospholipid FA

Secondary Outcome Measures

Plasma glucose
Serum insulin
Plasma ketones
Plasma free fatty acid
Total cholesterol
LDL cholesterol
HDL cholesterol
Triglycerides
Other lipoprotein fractions
Glucagon Like Peptide 1 (GLP1)
Glucose-Dependent Insulinotropic Polypeptide (GIP)
Cholecystokinin (CCK)
Peptide YY (PYY)
Ghrelin
Subjective appetite
Visual analog scale - mm. 0 mm - 100 mm. 0 mm = none and 100 mm = very strong

Full Information

First Posted
August 10, 2022
Last Updated
September 1, 2022
Sponsor
Odense University Hospital
Collaborators
Aalborg University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05498688
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
Aalborg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Low carbohydrate diet, LCD, Plasma FA composition, Free fatty acids, Cardiovascular disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low carbohydrate
Arm Type
Experimental
Arm Description
The intervention meal is a low-carbohydrate meal composed of 15 E% carbohydrates, 20 E% protein and 65 E% fat
Arm Title
Control meal
Arm Type
No Intervention
Arm 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
Intervention Type
Dietary Supplement
Intervention Name(s)
Low carbohydrate
Other Intervention Name(s)
LCD
Intervention Description
Participants will have a low carbohydrate meal
Primary Outcome Measure Information:
Title
Plasma fatty acid composition
Description
Quantified as weight percentage (wt%) of total plasma phospholipid FA
Time Frame
5 hours
Secondary Outcome Measure Information:
Title
Plasma glucose
Time Frame
5 hours
Title
Serum insulin
Time Frame
5 hours
Title
Plasma ketones
Time Frame
5 hours
Title
Plasma free fatty acid
Time Frame
5 hours
Title
Total cholesterol
Time Frame
5 hours
Title
LDL cholesterol
Time Frame
5 hours
Title
HDL cholesterol
Time Frame
5 hours
Title
Triglycerides
Time Frame
5 hours
Title
Other lipoprotein fractions
Time Frame
5 hours
Title
Glucagon Like Peptide 1 (GLP1)
Time Frame
5 hours
Title
Glucose-Dependent Insulinotropic Polypeptide (GIP)
Time Frame
5 hours
Title
Cholecystokinin (CCK)
Time Frame
5 hours
Title
Peptide YY (PYY)
Time Frame
5 hours
Title
Ghrelin
Time Frame
5 hours
Title
Subjective appetite
Description
Visual analog scale - mm. 0 mm - 100 mm. 0 mm = none and 100 mm = very strong
Time Frame
5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Stable antidiabetic treatment three months prior to inclusion. Well treated dyslipidemia (LDL cholesterol < 2.5 mmol/l and total cholesterol < 4.5 mmol/l at inclusion) with or without statins. BMI ≥ 25. Age ≥ 18 years. All participants have to understand oral and written Danish. All participants have to sign an informed consent after oral and written information on experimental design. Exclusion Criteria: Significant comorbidity, including liver disease. A history of cancer < 5 years or current chemotherapy. 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). Current treatment with glucocorticoids (systemic). Continuous treatment with steatosis-inducing drugs. Treatment with antibiotics during the last two months before inclusion. Low-carbohydrate diet prior to inclusion, or other restrictive diet. Weight-loss > 10 kg over the last three months before inclusion. Pregnancy or expected pregnancy within the next 6 months. Elevated blood pressure (180/110) with or without antihypertensives.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kurt Højlund, MD
Phone
+45 25320648
Email
kurt.hoejlund@rsyd.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Rasmussen
Email
juras17@student.sdu.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt Højlund, MD
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kurt Højlund, MD
Phone
+45 25320648
Email
kurt.hoejlund@rsyd.dk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs