A Study to Evaluate Direct Measurement of Proinsulin Clearance in Humans
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-003525
NCT ID: NCT03998293
Sponsor Protocol Number: 19-003525
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