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Hormone Therapy

proinsulin clearance for Healthy Subjects

Phase 4
Waitlist Available
Led By Adrian Vella
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Weight-stable, non-diabetic subjects from Biobank participants at Mayo Clinic, Rochester
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, each study will take an average of 8 hours
Awards & highlights

Study Summary

This trial is testing how different doses of proinsulin affects how quickly it's cleared from the circulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, each study will take an average of 8 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, each study will take an average of 8 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proinsulin Clearance
Proinsulin Distribution

Side effects data

From 2010 Phase 4 trial • 1034 Patients • NCT00966355
1%
diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Octreotide
Somatostatin
Terlipressin

Trial Design

1Treatment groups
Experimental Treatment
Group I: proinsulin clearanceExperimental Treatment1 Intervention
all participants will be studied once where somatostatin will be used to block endogenous insulin secretion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Somatostatin
2016
Completed Phase 4
~4200

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,210 Previous Clinical Trials
3,766,973 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,315,503 Total Patients Enrolled
Adrian VellaPrincipal InvestigatorMayo Clinic
6 Previous Clinical Trials
219 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are enrolled in this experiment?

"This trial has ceased recruitment; the initial post date was November 1st 2022 and it had its latest revision on December 13th 2021. In terms of alternative trials, 839 studies involving healthy subjects (HS) are presently enrolling patients, as well as 6 clinical tests for this particular treatment that are actively searching for participants."

Answered by AI

What types of people are suitable candidates for this trial?

"Eligibility for this trial requires that applicants are of healthy body condition and between the ages 25 to 65. 30 people will be selected in total."

Answered by AI

Is this experiment currently enrolling participants?

"According to the data provided on clinicaltrials.gov, this particular medical trial is not enrolling new participants. Originally posted in November of 2022 and last updated in December 2021, it currently does not have any open spots; however, 845 other trials are actively recruiting right now."

Answered by AI

Has this treatment undergone the necessary regulatory approval from the FDA?

"The safety of this treatment is determined to be a 3, with Phase 4 trials confirming its approval for use."

Answered by AI

In what contexts is this treatment typically employed?

"This therapeutic intervention is frequently employed to address biliary fistula, as well as conditions like secretory restriction, fistulae formation, and acromegaly."

Answered by AI

Is this trial the inaugural of its kind?

"At present, 6 trials involving this therapeutic intervention are active across 2 cities and 3 nations. The initial research project began in 2015 under the auspices of Pharmbio Korea Co., Ltd. This Phase 3 clinical trial included 20 patients and has since been followed by 29 other studies over the past six years."

Answered by AI

Is the current cohort of this experiment inclusive of those aged sixty and above?

"Those aged 25-65 are eligible to participate in the trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Direct Measurement of Proinsulin Clearance in Humans
Adrian Vella 2022. "Direct Measurement of Proinsulin Clearance in Humans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03998293.
~0 spots leftby Apr 2025
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