Direct Measurement of Proinsulin Clearance in Humans

NCT03998293 — Phase 4, Withdrawn, Mayo Clinic

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Registry	NCT03998293
Status	Withdrawn - Newly available data suggests that measuring proinsulin clearance would not enhance predictive value of serum proinsulin
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, basic science
Sponsor	Mayo Clinic (Other); collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions	Healthy
Interventions	Somatostatin (Drug)
Dates	start 2022-11-01 (estimated), primary completion 2023-12-01 (estimated), completion 2023-12-01 (estimated), first posted 2019-06-26, last updated 2022-12-15
Locations	1 site in United States

-Summary

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

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+Detailed description

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

+Arms and interventions

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

Somatostatin (Drug): infused to block endogenous insulin secretion over a 4 hour period

+Outcome measures

Primary outcomes

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

Sex: All, ages: 25 Years to 65 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Mayo Clinic in Rochester	Rochester, Minnesota	United States

+Investigators

Adrian Vella, Principal investigator, Mayo Clinic

+Funding

NIH grants: R01DK078645

My Notes

Public

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