Glucose Metabolism Disorders (Including Diabetes Mellitus)GLOXY-1NCT06334172
The Role of Oxytocin in Regulating Blood Glucose
A study testing Oxytocin in people with Glucose Metabolism Disorders (Including Diabetes Mellitus), run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
Investigating the effect of oxytocin on pancreatic endocrine functions by determining insulin and glucagon secretion within physiological ranges of plasma glucose. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Glucose Metabolism Disorders (Including Diabetes Mellitus)
- What is being tested?
- Oxytocin
- 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 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- BMI 19-25 kg/m2
Who cannot join
- Diabetes
- Heart-, liver or kidney disease
- More than 14 units of alcohol weekly, or drug abuse
- Smoking or any kind of nicotine products
- Alanin aminotransferase (ALAT) ≥ 2 × normal range
- Estimated glomerular filtration rate (eGFR) < 60 ml/min/1,73m2 or creatinine above normal range
Show all 11Show fewer
- Blood pressure > 140/90
- Hemoglobin < normal range
- Corrected QT Interval (Qtc) >0,45 sec. at electrocardiogram (ECG) at screening
- Known disease in the pituitary gland or previous pituitary surgery
- Any other disease/condition which the trial managers believe may affect participation in the trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Filip Krag Knop contact
Denmark1 site, 1 recruiting
- Recruiting
Center for Clinical Metabolic Research, Gentofte Hospital
Hellerup, Capital Region, 2900
Filip K Knop, MD, PhD, 004538674266, filip.krag.knop.01@regionh.dk
About this study
Investigating the effect of oxytocin on pancreatic endocrine functions by determining insulin and glucagon secretion within physiological ranges of plasma glucose.
Read the detailed description
Insulinotropic effects of oxytocin will be examined in 20 healthy men with body mass index (BMI) < 27 kg/m2, during a graded glucose infusion test with concomitant intravenous infusion of synthetic oxytocin or placebo in a randomized, double-blinded design. This will determine the effect of oxytocin on glucose-stimulated insulin and glucagon secretion. Additional changes in plasma/serum concentrations of C-peptide, glucose, glucose-dependent insulinotropic polypeptid (GIP), glucagon-like peptide 1 (GLP-1), and lipids will be assessed.
- Being tested
- Oxytocin, Placebo
- Keywords
- oxytocin, blood glucose, glucose stabilization
- Medical subject headings
- Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Oxytocin
PlaceboOther
Saline
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Infusion of placebo Receives: Other: Placebo |
| Oxytocin 0.1 IU/min | Experimental | Infusion of oxytocin 0.1 IU/min Receives: Drug: Oxytocin |
| Oxytocin 0.2 IU/min | Experimental | Infusion of oxytocin 0.2 IU/min Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin secretion - c-peptide
Insulin secretion, measured as percentual increase of area under the curve (AUC) for circulating c-peptide
Measured: From time 0 to time 180 min
Secondary outcomes (8)
Glucose
measured as percentual increase of AUC for circulating levels
Measured: From time 0 minutes to time 180 minutes
Insulin
measured as percentual increase of AUC for circulating levels
Measured: From time 0 minutes to time 180 minutes
Glucagon
measured as percentual increase of AUC for circulating levels
Measured: From time 0 minutes to time 180 minutes
GIP
measured as percentual increase of AUC for circulating levels
Measured: From time 0 minutes to time 180 minutes
GLP-1
measured as percentual increase of AUC for circulating levels
Measured: From time 0 minutes to time 180 minutes
Lipids
measured as percentual increase of AUCfor circulating levels
Measured: From time 0 minutes to time 180 minutes
Cross-linked C-telopeptide of type I collagen( CTX)
measured as percentual increase of AUC for circulating levels
Measured: From time 0 minutes to time 180 minutes
Procollagen type I N-terminal propeptide (P1NP)
measured as percentual increase of AUC for circulating levels
Measured: From time 0 minutes to time 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism Disorders (Including Diabetes Mellitus)Studies of the same condition, open and under way.
- 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
- Randomized, double-blinded, single-arm study. Each participant goes through three experimental days in a randomized order - acting as their own controls
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Krag Knop, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334172
- Sponsor's protocol ID
- H-23071221
- Acronym
- GLOXY-1
- Status last verified
- Apr 2024
- First submitted
- 8 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All published data will be made available to other researchers upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Oxytocin in Regulating Blood Glucose
- ClinicalTrials.gov ID
- NCT06334172
- Acronym / sponsor ID
- GLOXY-1 / H-23071221
- Keywords
- oxytocin, blood glucose, glucose stabilization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Mar 2024 (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.
Investigating the effect of oxytocin on pancreatic endocrine functions by determining insulin and glucagon secretion within physiological ranges of plasma glucose.
Detailed description
Insulinotropic effects of oxytocin will be examined in 20 healthy men with body mass index (BMI) < 27 kg/m2, during a graded glucose infusion test with concomitant intravenous infusion of synthetic oxytocin or placebo in a randomized, double-blinded design. This will determine the effect of oxytocin on glucose-stimulated insulin and glucagon secretion. Additional changes in plasma/serum concentrations of C-peptide, glucose, glucose-dependent insulinotropic polypeptid (GIP), glucagon-like peptide 1 (GLP-1), and lipids will be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized, double-blinded, single-arm study. Each participant goes through three experimental days in a randomized order - acting as their own controls
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboInfusion of placebo |
| Oxytocin 0.1 IU/min | Experimental | Drug: OxytocinInfusion of oxytocin 0.1 IU/min |
| Oxytocin 0.2 IU/min | Experimental | Drug: OxytocinInfusion of oxytocin 0.2 IU/min |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 19-25 kg/m2
Key exclusion criteria (11 listed)
- Diabetes
- Heart-, liver or kidney disease
- More than 14 units of alcohol weekly, or drug abuse
- Smoking or any kind of nicotine products
- Alanin aminotransferase (ALAT) ≥ 2 × normal range
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 |
|---|---|---|
| OxytocinOxytocin | Drug | Oxytocin 0.1 IU/min, Oxytocin 0.2 IU/min |
| PlaceboSaline | Other | Placebo |
Primary outcome
Insulin secretion - c-peptide
Time frame: From time 0 to time 180 min
Insulin secretion, measured as percentual increase of area under the curve (AUC) for circulating c-peptide
8 secondary outcomes
Glucose
Time frame: From time 0 minutes to time 180 minutes
Insulin
Time frame: From time 0 minutes to time 180 minutes
Glucagon
Time frame: From time 0 minutes to time 180 minutes
GIP
Time frame: From time 0 minutes to time 180 minutes
GLP-1
Time frame: From time 0 minutes to time 180 minutes
Lipids
Time frame: From time 0 minutes to time 180 minutes
Cross-linked C-telopeptide of type I collagen( CTX)
Time frame: From time 0 minutes to time 180 minutes
Procollagen type I N-terminal propeptide (P1NP)
Time frame: From time 0 minutes to time 180 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: Yes. All published data will be made available to other researchers upon reasonable request
Related trials for Glucose Metabolism Disorders (Including Diabetes Mellitus)
RecruitingObservational study
An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Continuous Glucose Monitoring in Patients Undergoing Cardiopulmonary Bypass
Glucose Metabolism Disorders (Including Diabetes Mellitus)
Active, not recruiting
Support-t Online Training in Youth Living With Type 1 Diabetes Transitioning to Adult Care
Diabetes Mellitus, Diabetes Mellitus, Type 1
Active, not recruitingObservational study
Monitoring of the Sympathetic/Vagal Balance Through Multiparametric Analysis of Heart Rate Variability (HRV)
Diabete Type 2, Heart Failure
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.
Filip Krag Knop contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Glucose Metabolism Disorders (Including Diabetes Mellitus), run by University Hospital, Gentofte, Copenhagen 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 1 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 4 Apr 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vivian Kliim-Hansen, MD (+4524476875, vivian.kliim-hansen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin secretion - c-peptide (time frame: From time 0 to time 180 min). 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 4 Apr 2024.