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Direct Measurement of Proinsulin Clearance in Humans

Direct Measurement of Proinsulin Clearance in Humans

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03998293
Enrollment
0
Registered
2019-06-26
Start date
2022-11-30
Completion date
2023-12-31
Last updated
2022-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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

Interventions

DRUGSomatostatin

infused to block endogenous insulin secretion over a 4 hour period

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Proinsulin Clearancethrough study completion, each study will take an average of 8 hoursThe half-life of proinsulin in a given individual
Proinsulin Distributionthrough study completion, each study will take an average of 8 hoursThe volume of distribution of proinsulin in a given individual

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026