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NCT03998293 Clinical Trial

Direct Measurement of Proinsulin Clearance in Humans

Healthy Clinical Trial

Official title:
Direct Measurement of Proinsulin Clearance in Humans

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03998293
Other study ID # 19-003525
Secondary ID R01DK078645
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date November 2022
Est. completion date December 2023

Study information
Verified date December 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proinsulin Clearance The half-life of proinsulin in a given individual through study completion, each study will take an average of 8 hours
Primary Proinsulin Distribution The volume of distribution of proinsulin in a given individual through study completion, each study will take an average of 8 hours
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