HealthyPhase 4NCT03998293
Direct Measurement of Proinsulin Clearance in Humans
A Phase 4 study testing Somatostatin in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to determine how quickly proinsulin is cleared from the circulation. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Somatostatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2022to Dec 2023
- Phase
- Phase 4
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Weight-stable, non-diabetic subjects from Biobank participants at Mayo Clinic, Rochester
Who cannot join
- Age < 25 or > 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).
- HbA1c ≥ 6.5%
- Use of glucose-lowering agents.
- For female subjects: positive pregnancy test at the time of enrollment or study
- History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
- Active systemic illness or malignancy.
- Symptomatic macrovascular or microvascular disease.
- Hormone replacement therapy >0.625 mg premarin daily
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Researchers are trying to determine how quickly proinsulin is cleared from the circulation.
Read the detailed description
proinsulin clearance is necessary to determine the rate of secretion into the circulation
- Conditions
- Healthy
- Being tested
- Somatostatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatostatinDrug
infused to block endogenous insulin secretion over a 4 hour period
| Study group | Role | What they receive |
|---|---|---|
| proinsulin clearance | Other | all participants will be studied once where somatostatin will be used to block endogenous insulin secretion Receives: Drug: Somatostatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proinsulin Clearance
The half-life of proinsulin in a given individual
Measured: through study completion, each study will take an average of 8 hours
Proinsulin Distribution
The volume of distribution of proinsulin in a given individual
Measured: through study completion, each study will take an average of 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study startNov 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Newly available data suggests that measuring proinsulin clearance would not enhance predictive value of serum proinsulin
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrian Vella, Mayo Clinic
- Investigators
- Adrian Vella, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998293
- Sponsor's protocol ID
- 19-003525
- Other IDs
- R01DK078645
- Status last verified
- Dec 2022
- First submitted
- 24 Jun 2019
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Measurement of Proinsulin Clearance in Humans
- ClinicalTrials.gov ID
- NCT03998293
- Acronym / sponsor ID
- 19-003525
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Newly available data suggests that measuring proinsulin clearance would not enhance predictive value of serum proinsulin
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Nov 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 26 Jun 2019 (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.
Researchers are trying to determine how quickly proinsulin is cleared from the circulation.
Detailed description
proinsulin clearance is necessary to determine the rate of secretion into the circulation
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| proinsulin clearance | Other | Drug: Somatostatinall participants will be studied once where somatostatin will be used to block endogenous insulin secretion |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Weight-stable, non-diabetic subjects from Biobank participants at Mayo Clinic, Rochester
Key exclusion criteria (8 listed)
- Age < 25 or > 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).
- HbA1c ≥ 6.5%
- Use of glucose-lowering agents.
- For female subjects: positive pregnancy test at the time of enrollment or study
- History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
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 |
|---|---|---|
| Somatostatininfused to block endogenous insulin secretion over a 4 hour period | Drug | proinsulin clearance |
Primary outcome
Proinsulin Clearance
Time frame: through study completion, each study will take an average of 8 hours
The half-life of proinsulin in a given individual
Proinsulin Distribution
Time frame: through study completion, each study will take an average of 8 hours
The volume of distribution of proinsulin in a given individual
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Adrian Vella principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Somatostatin in people with Healthy, run by Mayo Clinic at 1 site in United States.
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 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: withdrawn, as of the sponsor's last update on 15 Dec 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proinsulin Clearance (time frame: through study completion, each study will take an average of 8 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?
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 15 Dec 2022.