Direct Measurement of Proinsulin Clearance in Humans

NCT03998293 | Withdrawn Phase 4 FDA Drug

• 2 other identifiers: 19-003525R01DK078645
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Proinsulin Clearance

  The half-life of proinsulin in a given individual

  through study completion, each study will take an average of 8 hours

• Proinsulin Distribution

  The volume of distribution of proinsulin in a given individual

  through study completion, each study will take an average of 8 hours

Study Arms (1)

proinsulin clearance

OTHER

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

Drug: Somatostatin

Interventions

Somatostatin DRUG

infused to block endogenous insulin secretion over a 4 hour period

proinsulin clearance

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Weight-stable, non-diabetic subjects from Biobank participants at Mayo Clinic, Rochester

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Somatostatin

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Adrian Vella

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 26, 2019
• Study Start: November 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)