Direct Measurement of Proinsulin Clearance in Humans | NCT03998293

Studies
Direct Measurement of Proinsulin Clearance in Humans

NCT03998293

Sponsor

Mayo Clinic

Status

Withdrawn

Last Update Posted

Dec 15, 2022Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Healthy

Interventions

Somatostatin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01DK078645	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Newly available data suggests that measuring proinsulin clearance would not enhance predictive value of serum proinsulin

Expanded Access Info

Start Date

Nov 2022Estimated

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Jun 24, 2019

First Submission Date that Met QC Criteria

Jun 25, 2019

First Posted Date

Jun 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2022

Last Update Posted Date

Dec 15, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Adrian Vella, Principal Investigator, Mayo ClinicPrincipal Investigator

Lead Sponsor

Mayo ClinicOTHER

Collaborators

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
proinsulin clearance	Other	all participants will be studied once where somatostatin will be used to block endogenous insulin secretion	Drug: Somatostatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Somatostatin	Drug	infused to block endogenous insulin secretion over a 4 hour period	proinsulin clearance

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proinsulin Clearance	The half-life of proinsulin in a given individual	through study completion, each study will take an average of 8 hours
Proinsulin Distribution	The volume of distribution of proinsulin in a given individual	through study completion, each study will take an average of 8 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Weight-stable, non-diabetic subjects from Biobank participants at Mayo Clinic, Rochester

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adrian Vella	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013004	Somatostatin

Ancestor Terms

ID	Term
D010905	Pituitary Hormone Release Inhibiting Hormones
D007028	Hypothalamic Hormones
D036361	Peptide Hormones
D006728	Hormones

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Browse Branches

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