Type 2 DiabetesNCT05498688
The Acute Effect of Low-carb Diet on the Plasma Fatty Acid Composition in Type 2 Diabetes
A study testing Low carbohydrate in people with Type 2 Diabetes, run by Odense University Hospital at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Low carbohydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Aug 2022to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Julie Rasmussen contact
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense, 5000
Kurt Højlund, MD, +45 25320648, kurt.hoejlund@rsyd.dk
About this study
Official title: The Acute Effect of a Low-carbohydrate Meal on the Plasma Fatty Acid Composition in Patients With Type 2 Diabetes
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Low carbohydrate
- Keywords
- Low carbohydrate diet, LCD, Plasma FA composition, Free fatty acids, Cardiovascular disease
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low carbohydrateDietary supplement
Also called LCD
Participants will have a low carbohydrate meal
| Study group | Role | What they receive |
|---|---|---|
| Low carbohydrate | Experimental | The intervention meal is a low-carbohydrate meal composed of 15 E% carbohydrates, 20 E% protein and 65 E% fat Receives: Dietary Supplement: Low carbohydrate |
| Control meal | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma fatty acid composition
Quantified as weight percentage (wt%) of total plasma phospholipid FA
Measured: 5 hours
Secondary outcomes (15)
Plasma glucose
Measured: 5 hours
Serum insulin
Measured: 5 hours
Plasma ketones
Measured: 5 hours
Plasma free fatty acid
Measured: 5 hours
Total cholesterol
Measured: 5 hours
LDL cholesterol
Measured: 5 hours
HDL cholesterol
Measured: 5 hours
Triglycerides
Measured: 5 hours
Other lipoprotein fractions
Measured: 5 hours
Glucagon Like Peptide 1 (GLP1)
Measured: 5 hours
Glucose-Dependent Insulinotropic Polypeptide (GIP)
Measured: 5 hours
Cholecystokinin (CCK)
Measured: 5 hours
Peptide YY (PYY)
Measured: 5 hours
Ghrelin
Measured: 5 hours
Subjective appetite
Visual analog scale - mm. 0 mm - 100 mm. 0 mm = none and 100 mm = very strong
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start25 Aug 2022
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital
- Responsible party
- Principal investigator, Karina Vejrum Sørensen, Odense University Hospital
- Investigators
- Kurt Højlund, MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498688
- Sponsor's protocol ID
- S-20220003
- Status last verified
- Sep 2022
- First submitted
- 10 Aug 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of a Low-carbohydrate Meal on the Plasma Fatty Acid Composition in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05498688
- Acronym / sponsor ID
- S-20220003
- Conditions
- Type 2 Diabetes
- Keywords
- Low carbohydrate diet, LCD, Plasma FA composition, Free fatty acids, Cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University Hospital
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low carbohydrate | Experimental | Dietary Supplement: Low carbohydrateThe intervention meal is a low-carbohydrate meal composed of 15 E% carbohydrates, 20 E% protein and 65 E% fat |
| Control meal | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low carbohydrateAlso: LCDParticipants will have a low carbohydrate meal | Dietary supplement | Low carbohydrate |
Primary outcome
Plasma fatty acid composition
Time frame: 5 hours
Quantified as weight percentage (wt%) of total plasma phospholipid FA
15 secondary outcomes
Plasma glucose
Time frame: 5 hours
Serum insulin
Time frame: 5 hours
Plasma ketones
Time frame: 5 hours
Plasma free fatty acid
Time frame: 5 hours
Total cholesterol
Time frame: 5 hours
LDL cholesterol
Time frame: 5 hours
HDL cholesterol
Time frame: 5 hours
Triglycerides
Time frame: 5 hours
Other lipoprotein fractions
Time frame: 5 hours
Glucagon Like Peptide 1 (GLP1)
Time frame: 5 hours
Glucose-Dependent Insulinotropic Polypeptide (GIP)
Time frame: 5 hours
Cholecystokinin (CCK)
Time frame: 5 hours
Peptide YY (PYY)
Time frame: 5 hours
Ghrelin
Time frame: 5 hours
Subjective appetite
Time frame: 5 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Rasmussen contact
Kurt Højlund, MD principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low carbohydrate in people with Type 2 Diabetes, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kurt Højlund, MD (+45 25320648, kurt.hoejlund@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma fatty acid composition (time frame: 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.