Type2 DiabetesNCT04907838
Insulin Stimulated Vasodilation in Patients With Type 2 Diabetes
A study testing Insulin clamp, BQ123 and BQ123 + BQ788 in people with Type2 Diabetes, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
This study evaluates the role of endothelin in insulin stimulated vasodilation and glucose uptake. The subjects will complete an hyperinsulinemic euglycemic clamp with and without blockade of the endothelin receptors. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Insulin clamp, BQ123 and BQ123 + BQ788
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2018to 30 Jul 2021
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 2 diabetes OR healthy control (no type 2 diabetes)
- BMI<32
Who cannot join
- heart disease
- pregnancy or birth within 3 month
- smoking
- Kidney disease
- beta-blockers
- insulin treatment (for type 2 diabetics)
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the role of endothelin in insulin stimulated vasodilation and glucose uptake. The subjects will complete an hyperinsulinemic euglycemic clamp with and without blockade of the endothelin receptors.
- Conditions
- Type2 Diabetes
- Being tested
- Insulin clamp, BQ123, BQ123 + BQ788
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin clampDrug
Continous infusion insulin + glucose
BQ123Drug
Continuous infusion of Insulin + glucose + BQ123
BQ123 + BQ788Drug
Continous infusion of insulin + glucose + BQ123 + BQ788
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetics | Experimental | BQ123 (25 nmol/min), BQ788 (25 nmol/min) Receives: Drug: Insulin clamp; Drug: BQ123; Drug: BQ123 + BQ788 |
| Healthy controls | Experimental | BQ123 (25 nmol/min), BQ788 (25 nmol/min) Receives: Drug: Insulin clamp; Drug: BQ123; Drug: BQ123 + BQ788 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose infusion rate
Glucose infusion rate required to maintain euglycemia during insulin clamp with and without endothelin blockade
Measured: 3.5 hours
Leg blood flow
Effect of endothelin receptor blockade on leg blood flow (ultrasound Doppler) during insulin clamp with and without endothelin blockade
Measured: 3.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start1 May 2018
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
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 Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas at Arlington
- Responsible party
- Principal investigator, Stefan Mortensen, University of Southern Denmark
- Investigators
- Stefan Mortensen, DMSc, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907838
- Sponsor's protocol ID
- s-20180040
- Status last verified
- May 2021
- First submitted
- 4 May 2019
- Last updated
- 1 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Young BE, Padilla J, Finsen SH, Fadel PJ, Mortensen SP. Role of Endothelin-1 Receptors in Limiting Leg Blood Flow and Glucose Uptake During Hyperinsulinemia in Type 2 Diabetes. Endocrinology. 2022 Mar 1;163(3):bqac008. doi: 10.1210/endocr/bqac008.
PubMed 35084435
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Stimulated Vasodilation in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04907838
- Acronym / sponsor ID
- s-20180040
- Conditions
- Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- The University of Texas at Arlington
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 1 Jun 2021 (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.
This study evaluates the role of endothelin in insulin stimulated vasodilation and glucose uptake. The subjects will complete an hyperinsulinemic euglycemic clamp with and without blockade of the endothelin receptors.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetics | Experimental | Drug: Insulin clamp, Drug: BQ123, Drug: BQ123 + BQ788BQ123 (25 nmol/min), BQ788 (25 nmol/min) |
| Healthy controls | Experimental | Drug: Insulin clamp, Drug: BQ123, Drug: BQ123 + BQ788BQ123 (25 nmol/min), BQ788 (25 nmol/min) |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes OR healthy control (no type 2 diabetes)
- BMI<32
Key exclusion criteria (6 listed)
- heart disease
- pregnancy or birth within 3 month
- smoking
- Kidney disease
- beta-blockers
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 |
|---|---|---|
| Insulin clampContinous infusion insulin + glucose | Drug | Healthy controls, Type 2 diabetics |
| BQ123Continuous infusion of Insulin + glucose + BQ123 | Drug | Healthy controls, Type 2 diabetics |
| BQ123 + BQ788Continous infusion of insulin + glucose + BQ123 + BQ788 | Drug | Healthy controls, Type 2 diabetics |
Primary outcome
Glucose infusion rate
Time frame: 3.5 hours
Glucose infusion rate required to maintain euglycemia during insulin clamp with and without endothelin blockade
Leg blood flow
Time frame: 3.5 hours
Effect of endothelin receptor blockade on leg blood flow (ultrasound Doppler) during insulin clamp with and without endothelin blockade
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Derived from this study: PubMed 35084435Young BE, Padilla J, Finsen SH, Fadel PJ, Mortensen SP. Role of Endothelin-1 Receptors in Limiting Leg Blood Flow and Glucose Uptake During Hyperinsulinemia in Type 2 Diabetes. Endocrinology. 2022 Mar 1;163(3):bqac008. doi: 10.1210/endocr/bqac008.
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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.
Stefan Mortensen, DMSc principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin clamp, BQ123 and BQ123 + BQ788 in people with Type2 Diabetes, run by University of Southern Denmark 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 2 inclusion and 6 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 1 Jun 2021. 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?
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?
Glucose infusion rate (time frame: 3.5 hours). The study lists 2 primary outcomes in all. 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 NCT04907838, 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 1 Jun 2021.