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Clinical Investigation for Type 2 Diabetes (Renal-HEIR Trial)

Phase 1 & 2

Waitlist Available

Led By Petter Bjornstad, MD

Research Sponsored by University of Colorado Denver School of Medicine Barbara Davis Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 min

Awards & highlights

Renal-HEIR Trial Summary

This trial is studying the effects of different types of insulin on kidney function in young people with type 2 diabetes.

Eligible Conditions

Type 2 Diabetes
Obesity
Kidney Disease

Renal-HEIR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 min

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 min

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 min for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effective renal plasma flow (ERPF)

Glomerular filtration rate (GFR)

Secondary outcome measures

Insulin sensitivity

Renal oxygenation

Renal perfusion

Other outcome measures

Detachment and endothelial fenestration of glomeruli

Epigenetic profiling

Foot process width of glomeruli

+3 more

Renal-HEIR Trial Design

1Treatment groups

Experimental Treatment

Group I: Clinical InvestigationExperimental Treatment3 Interventions

All participants will undergo GFR (Iohexol Inj 300 MG/ML), ERPF (Aminohippurate Sodium Inj 20%) in addition to renal BOLD and ASL MRI.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Renal Biopsy

2007

N/A

~110

Iohexol Inj 300 MG/ML

2019

Completed Phase 4

~20

Aminohippurate Sodium Inj 20%

2018

Completed Phase 2

~130

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Colorado Denver School of Medicine Barbara Davis CenterLead Sponsor

16 Previous Clinical Trials

1,079 Total Patients Enrolled

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,143,483 Total Patients Enrolled

Petter Bjornstad, MDPrincipal Investigator - University of Colorado School of Medicine

University of Colorado, Denver

6 Previous Clinical Trials

350 Total Patients Enrolled

Media Library

Clinical Investigation Clinical Trial Eligibility Overview. Trial Name: NCT03584217 — Phase 1 & 2

Type 2 Diabetes Research Study Groups: Clinical Investigation

Type 2 Diabetes Clinical Trial 2023: Clinical Investigation Highlights & Side Effects. Trial Name: NCT03584217 — Phase 1 & 2

Clinical Investigation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03584217 — Phase 1 & 2

Frequently Asked Questions

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

How many individuals have been recruited to participate in this research?

"Affirmative, according to the clinicaltrials.gov portal, this study is currently recruiting patients. It was initially posted on October 1st 2018 and last modified on January 28th 2022 with a requirement of 100 participants across one medical centre."

Answered by AI

Are there any openings available in this trial for prospective participants?

"As reported on clinicaltrials.gov this medical trial is actively seeking participants; the initial post was made on October 1st 2018, and it has been revised most recently on January 28th 2022."

Answered by AI

Is there an opportunity for me to join this medical experiment?

"In order to qualify for this trial, the participant must be aged between 12 and 21 and have a diagnosis of type 2 diabetes mellitus. Currently, there is an effort underway to recruit roughly 100 people for the research project."

Answered by AI