Direct Measurement of Proinsulin Clearance in Humans

Mayo Clinic

Status and phase: Withdrawn; Phase 4

Conditions: Healthy

Treatments: Drug: Somatostatin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03998293

19-003525

R01DK078645 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

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

Sex: All

Ages: 25 to 65 years old

Volunteers: 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

proinsulin clearance

Other group

Description:

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

Treatment:

Drug: Somatostatin