Direct Measurement of Proinsulin Clearance in Humans

Sponsor

Mayo Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03998293

Collaborator

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

Enrollment

Location

Arm

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Somatostatin	Phase 4

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Direct Measurement of Proinsulin Clearance in Humans

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: proinsulin clearance all participants will be studied once where somatostatin will be used to block endogenous insulin secretion	Drug: Somatostatin infused to block endogenous insulin secretion over a 4 hour period

Arm

Intervention/Treatment

Other: proinsulin clearance

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

Drug: Somatostatin

infused to block endogenous insulin secretion over a 4 hour period

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

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

Investigators

Principal Investigator: Adrian Vella, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Adrian Vella, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT03998293

Other Study ID Numbers:

19-003525
R01DK078645

First Posted:

Jun 26, 2019

Last Update Posted:

Dec 14, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Somatostatin

Study Results

No Results Posted as of Dec 14, 2021