NCT05498688

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

August 25, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

August 10, 2022

Last Update Submit

September 1, 2022

Conditions

Type 2 Diabetes

Keywords

Low carbohydrate dietLCDPlasma FA compositionFree fatty acidsCardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • Plasma fatty acid composition

    Quantified as weight percentage (wt%) of total plasma phospholipid FA

    5 hours

Secondary Outcomes (15)

  • Plasma glucose

    5 hours

  • Serum insulin

    5 hours

  • Plasma ketones

    5 hours

  • Plasma free fatty acid

    5 hours

  • Total cholesterol

    5 hours

  • +10 more secondary outcomes

Study Arms (2)

Low carbohydrate

EXPERIMENTAL

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

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

Interventions

Low carbohydrateDIETARY_SUPPLEMENT

Participants will have a low carbohydrate meal

Also known as: LCD
Low carbohydrate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • Pregnancy or expected pregnancy within the next 6 months.
  • Elevated blood pressure (180/110) with or without antihypertensives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kurt Højlund, MD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kurt Højlund, MD

CONTACT

+45 25320648kurt.hoejlund@rsyd.dk

Julie Rasmussen

CONTACT

juras17@student.sdu.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nutrition consultant

Study Record Dates

First Submitted

August 10, 2022

First Posted

August 12, 2022

Study Start

August 25, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

September 7, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)