A Study to Evaluate Direct Measurement of Proinsulin Clearance in Humans

Overview

About this study

The purpose of this study is to determine if changes in fasting glucose and FFA concentrations alter 1st phase insulin secretion and proinsulin secretion in non-diabetic and pre-diabetic humans after determining the proinsulin volume of distribution, clearance rate and half-life in humans.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Up to 40 weight-stable, non-diabetic subjects will be recruited from Biobank participants at Mayo Clinic, Rochester.
  • Potentially eligible subjects who express a desire to be contacted by the research team will be invited to meet with the PI and / or another member of the study team.
  • Interested subjects will come to the Clinical Research Unit for a screening visit.

Exclusion Criteria:

  • Age < 25 or > 65 years old (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.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Adrian Vella, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20461885

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