Direct Measurement of Proinsulin Clearance in Humans

NCT ID: NCT03998293

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2023-12-31

Brief Summary

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Researchers are trying to determine how quickly proinsulin is cleared from the circulation.

Detailed Description

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proinsulin clearance is necessary to determine the rate of secretion into the circulation

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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proinsulin clearance

all participants will be studied once where somatostatin will be used to block endogenous insulin secretion

Group Type OTHER

Somatostatin

Intervention Type DRUG

infused to block endogenous insulin secretion over a 4 hour period

Interventions

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Somatostatin

infused to block endogenous insulin secretion over a 4 hour period

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Responsible Party

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Adrian Vella

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adrian Vella

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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R01DK078645

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-003525

Identifier Type: -

Identifier Source: org_study_id