NCT05581043Completed

Pre-meals of 3-hydroxybutyrate in Type 2 Diabetes

Pre-meals of 3-hydroxybutyrate for People With Type 2 Diabetes

Source: ClinicalTrials.gov · Last updated 17 Jan 2024

Brief summary (registry, in English)

Hyperglycemia following meals in patients with type 2 diabetes mellitus (T2DM) is a common problem. Recently, our group found that oral consumption of the ketone metabolite, 3-hydroxybutyrate (3-OHB), effectively stimulates insulin secretion and delays gastric emptying.The aim of this study is to investigate the dose/response relationship between 3-OHB servings of 0, 10, 20 and 40 grams 30 minutes before an OGTT and, ii) investigate the role of timing by serving 20 grams of 3-OHB at different timepoints ahead of an OGTT (0, 30 and 60 minutes)

Status (registry): Completed
Study type: Interventional
Enrollment: 10 (actual)
First submitted: 4 Oct 2022
Start date: 12 Jan 2023
Primary completion date: 1 Jan 2024
Lead sponsor: University of Aarhus
Diseases: Type 2 diabetes
NCT number: NCT05581043

What you commit to

Study type: Interventional
Participants enrolled: 10
From 12 Jan 2023 to the primary completion date, 1 Jan 2024
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

Ongoing cancer or other acute/chronic serious diseases (PI will determine)

Lab values

Hba1c \> 70
Severe liver disease (Child-Pugh score \>10) or kidney disease (eGFR\< 40 ml/min)

Other

Anemia (Hgb \< 6.5 mM)
History with pancreatitis
Practicing ketogenic diets (i.e., low-carb diet, fasting regime)
Inability to understand Danish or English

Who the study is looking for

Older than 18 years of age
Type 2 diabetes diagnosis
No antiglycemic treatment or monotherapy with metformin

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Department of Endocrinology and Internal Medicine Coordinator of this site? Confirm its status	Aarhus	Denmark	Unknown status

Related publications

Ketone supplementation dose-dependently lowers postprandial blood glucose, lipid and ghrelin levels in individuals with type 2 diabetes: a randomised crossover study.Diabetologia · 2026 · PMID 41315088

This page is information, not medical advice. Discuss any trial with your doctor.