MedPath

Direct Measurement of Proinsulin Clearance in Humans

Phase 4
Withdrawn
Conditions
Healthy
Interventions
Registration Number
NCT03998293
Lead Sponsor
Mayo Clinic
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

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
proinsulin clearanceSomatostatinall participants will be studied once where somatostatin will be used to block endogenous insulin secretion
Primary Outcome Measures
NameTimeMethod
Proinsulin Distributionthrough study completion, each study will take an average of 8 hours

The volume of distribution of proinsulin in a given individual

Proinsulin Clearancethrough study completion, each study will take an average of 8 hours

The half-life of proinsulin in a given individual

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Mayo Clinic in Rochester

🇺🇸

Rochester, Minnesota, United States

© Copyright 2025. All Rights Reserved by MedPath