Type 1 Diabetes MellitusNCT04656236
Metabolic Effects of Exogenous 3-hydroxybutyrate in Patients With Type 1 Diabetes and Healthy Controls
A study testing 3-hydroxybutyrate in people with Type 1 Diabetes Mellitus and Diabetic Ketoacidosis, run by University of Aarhus at 1 site in Denmark.
Trial summary
The main objective of this clinical trial is to study the metabolic effects of intravenous infusion of the ketone body, 3-hydroxybutyrate (3-OHB), in patients with type 1 diabetes and healthy control subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus, Diabetic Ketoacidosis
- What is being tested?
- 3-hydroxybutyrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2021to 1 Mar 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 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Type 1 diabetes diagnosis
- C-peptide negative
- 19 < BMI < 26
- written consent
- 19 < BMI < 26
- written consent
Who cannot join
- Severe comorbidity
- Regular medication apart from insulin (except over-the-counter medicines)
- Use of long acting insulin analogues, that work > 24 hours, e.g. Tresiba
- PI finds the patient not fit (e.g. mental illness, too nervous, unacceptable screening blood tests or other).
- Healthy control subjects:
- Chronic disease
- Regular medication (except over-the-counter medicines)
- PI finds the patient not fit (e.g. mental illness, too nervous, unacceptable screening blood tests or other).
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this clinical trial is to study the metabolic effects of intravenous infusion of the ketone body, 3-hydroxybutyrate (3-OHB), in patients with type 1 diabetes and healthy control subjects. Moreover, the investigators plan to examine regulatory mechanisms of 3-OHB that may be related to diabetic ketoacidosis.
The hypotheses are:
Read more
- 3-OHB related inhibition of lipolysis is impaired in patients with type 1 diabetes.
- Intravenous infusion of 3-OHB affects signaling pathways involved in the metabolic regulation in patients with type 1 diabetes and healthy controls.
- 3-OHB infusion improves cardiac function in patients with type 1 diabetes and healthy controls.
The effects of 3-OHB will be investigated by isotopic tracers examinations, fat and muscle biopsies and blood samples. To evaluate effects on cardiac function echocardiography will be performed.
- Conditions
- Type 1 Diabetes Mellitus, Diabetic Ketoacidosis
- Being tested
- 3-hydroxybutyrate
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetic Ketoacidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-hydroxybutyrateBiological
3-hydroxybutyrate is a metabolite, produced in the human body.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 3 hours of continuously intravenous infusion of 3-hydroxybutyrate. Receives: Biological: 3-hydroxybutyrate |
| Control | Placebo comparator | 3 hours of continuously intravenous infusion of saline (NaCl). Receives: Biological: 3-hydroxybutyrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in lipolysis rate
Measured as differences in palmitate flux
Measured: After 3 hours of interventions
Secondary outcomes (5)
Changes in protein metabolism
Measured as differences in forearm and whole body tracer kinetics
Measured: After 3 hours of interventions
Changes in glucose kinetics
Measured by glucose tracer.
Measured: After 3 hours of interventions
Cardiac function
Changes in cardiac output and left ventricular ejection fraction measured by echocardiography
Measured: After 2-3 hours of interventions
Changes in signaling in muscle and adipose tissue
Western blot examinations of muscle and adipose tissue biopsies
Measured: After 1,5-3 hours of interventions
Differences in circulating concentrations of 3-hydroxybutyrate, glucose, free fatty acids, insulin, glucagon and C-peptide
Blood samples
Measured: During the 3 hours intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start1 Jan 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover design in 2 different groups, patients with type 1 diabetes and healthy controls.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Niels Møller, Professor, Study director, Department of Endocrinology and Steno Diabetes Center Aarhus, Aarhus University HospitalMaj Bangshaab, MD, Principal investigator, Steno Diabetes Center Aarhus and Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656236
- Sponsor's protocol ID
- 1-10-72-251-20
- Status last verified
- Dec 2021
- First submitted
- 30 Nov 2020
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bangshaab M, Svart MV, Rittig N, Pedersen MGB, Voigt J, Jessen N, Moller N. Metabolic effects of 3-hydroxybutyrate infusion in individuals with type 1 diabetes compared with healthy control participants: a randomised crossover trial showing intact feedback suppression of lipolysis. Diabetologia. 2025 Jul;68(7):1390-1402. doi: 10.1007/s00125-025-06423-5. Epub 2025 Apr 10.
PubMed 40210728
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Exogenous 3-hydroxybutyrate in Patients With Type 1 Diabetes and Healthy Controls
- ClinicalTrials.gov ID
- NCT04656236
- Acronym / sponsor ID
- 1-10-72-251-20
- Conditions
- Type 1 Diabetes Mellitus, Diabetic Ketoacidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 7 Dec 2020 (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 main objective of this clinical trial is to study the metabolic effects of intravenous infusion of the ketone body, 3-hydroxybutyrate (3-OHB), in patients with type 1 diabetes and healthy control subjects. Moreover, the investigators plan to examine regulatory mechanisms of 3-OHB that may be related to diabetic ketoacidosis.
The hypotheses are:
- 3-OHB related inhibition of lipolysis is impaired in patients with type 1 diabetes.
- Intravenous infusion of 3-OHB affects signaling pathways involved in the metabolic regulation in patients with type 1 diabetes and healthy controls.
- 3-OHB infusion improves cardiac function in patients with type 1 diabetes and healthy controls.
The effects of 3-OHB will be investigated by isotopic tracers examinations, fat and muscle biopsies and blood samples. To evaluate effects on cardiac function echocardiography will be performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Crossover design in 2 different groups, patients with type 1 diabetes and healthy controls.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Biological: 3-hydroxybutyrate3 hours of continuously intravenous infusion of 3-hydroxybutyrate. |
| Control | Placebo comparator | Biological: 3-hydroxybutyrate3 hours of continuously intravenous infusion of saline (NaCl). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Type 1 diabetes diagnosis
- C-peptide negative
- 19 < BMI < 26
- written consent
- 19 < BMI < 26
Key exclusion criteria (8 listed)
- Severe comorbidity
- Regular medication apart from insulin (except over-the-counter medicines)
- Use of long acting insulin analogues, that work > 24 hours, e.g. Tresiba
- PI finds the patient not fit (e.g. mental illness, too nervous, unacceptable screening blood tests or other).
- Chronic disease
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 |
|---|---|---|
| 3-hydroxybutyrate3-hydroxybutyrate is a metabolite, produced in the human body. | Biological | Control, Intervention |
Primary outcome
Differences in lipolysis rate
Time frame: After 3 hours of interventions
Measured as differences in palmitate flux
5 secondary outcomes
Changes in protein metabolism
Time frame: After 3 hours of interventions
Changes in glucose kinetics
Time frame: After 3 hours of interventions
Cardiac function
Time frame: After 2-3 hours of interventions
Changes in signaling in muscle and adipose tissue
Time frame: After 1,5-3 hours of interventions
Differences in circulating concentrations of 3-hydroxybutyrate, glucose, free fatty acids, insulin, glucagon and C-peptide
Time frame: During the 3 hours intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Derived from this study: PubMed 40210728Bangshaab M, Svart MV, Rittig N, Pedersen MGB, Voigt J, Jessen N, Moller N. Metabolic effects of 3-hydroxybutyrate infusion in individuals with type 1 diabetes compared with healthy control participants: a randomised crossover trial showing intact feedback suppression of lipolysis. Diabetologia. 2025 Jul;68(7):1390-1402. doi: 10.1007/s00125-025-06423-5. Epub 2025 Apr 10.
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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.
Niels Møller, Professor study director
Department of Endocrinology and Steno Diabetes Center Aarhus, Aarhus University Hospital
Maj Bangshaab, MD principal investigator
Steno Diabetes Center Aarhus and Aarhus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-hydroxybutyrate in people with Type 1 Diabetes Mellitus and Diabetic Ketoacidosis, run by University of Aarhus 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 8 Mar 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in lipolysis rate (time frame: After 3 hours of interventions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04656236, which also lists 1 linked publication.
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 8 Mar 2022.