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Procedure

Insulin Deprivation Effects on Protein Synthesis in Type 1 Diabetes

N/A

Waitlist Available

Led By K. Sreekumaran Nair, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

- Able to provide written consent.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 7 hours

Awards & highlights

Study Summary

This trial aims to uncover how insulin affects people with Type 1 Diabetes and their overall health.

Who is the study for?

This trial is for individuals who can legally consent and have Type 1 Diabetes. It aims to explore how insulin affects various body functions in these patients.Check my eligibility

What is being tested?

The study investigates the impact of insulin deprivation and high blood sugar on protein synthesis in muscles. Participants will undergo a muscle biopsy, consume Jell-O with amino acids, and receive dextrose.See study design

What are the potential side effects?

Potential side effects may include discomfort or bruising at the biopsy site, allergic reactions to the amino acids in Jell-O, and changes in blood sugar levels due to dextrose.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 7 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 7 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 7 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

Protein synthesis

Trial Design

6Treatment groups

Experimental Treatment

Group I: Type 1 Diabetes Mellitus (T1DM) Insulin-Treated with HyperglycemiaExperimental Treatment3 Interventions

Subjects will be continue their baseline insulin infusion for 2 hours and then receive an intravenous dextrose infusion to maintain elevated blood sugar levels. Blood draws will be obtained to monitor glucose levels along with a muscle biopsy following consumption of a Jell-O with Amino acids.

Group II: Type 1 Diabetes Mellitus (T1DM) Insulin TreatedExperimental Treatment2 Interventions

Subjects will continue their baseline insulin infusion while maintaining a target blood glucose range. Blood draws will be obtained to monitor glucose levels along with a muscle biopsy following consumption of a Jell-O with Amino acids.

Group III: Type 1 Diabetes Mellitus (T1DM) Insulin DeprivedExperimental Treatment2 Interventions

Subjects will have their insulin infusions replaced with saline and have blood draws to monitor glucose levels along with a muscle biopsy following consumption of a Jell-O with Amino acids.

Group IV: Non-Diabetic ControlsExperimental Treatment2 Interventions

Subjects will have blood draws to monitor glucose levels along with a muscle biopsy following consumption of a Jell-O with Amino acids.

Group V: Diabetes after Total Pancreatectomized (DATP) Insulin TreatedExperimental Treatment2 Interventions

Group VI: Diabetes after Total Pancreatectomized (DATP) Insulin DeprivedExperimental Treatment2 Interventions

Subjects will have their insulin infusions replaced with saline and have blood draws to monitor glucose levels along with a muscle biopsy following consumption of a Jell-O with Amino acids.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Muscle Biopsy

2016

Completed Phase 1

~150

Dextrose

2013

Completed Phase 4

~1420

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,205 Previous Clinical Trials

3,766,714 Total Patients Enrolled

K. Sreekumaran Nair, MDPrincipal InvestigatorMayo Clinic

Media Library

Muscle Biopsy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05985135 — N/A

Type 1 Diabetes Research Study Groups: Diabetes after Total Pancreatectomized (DATP) Insulin Deprived, Type 1 Diabetes Mellitus (T1DM) Insulin Deprived, Type 1 Diabetes Mellitus (T1DM) Insulin Treated, Type 1 Diabetes Mellitus (T1DM) Insulin-Treated with Hyperglycemia, Non-Diabetic Controls, Diabetes after Total Pancreatectomized (DATP) Insulin Treated

Type 1 Diabetes Clinical Trial 2023: Muscle Biopsy Highlights & Side Effects. Trial Name: NCT05985135 — N/A

Muscle Biopsy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05985135 — N/A

Frequently Asked Questions

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

What requirements must one meet to be accepted into this research endeavor?

"Candidates interested in this study must possess type 1 diabetes and be aged between 18 to 70 years old. There are approximately seventy spots available for qualified individuals."

Answered by AI

Is this research project enrolling participants aged thirty and above?

"This clinical trial is open to participants aged 18-70. 219 trials exist for those younger than the age of majority, and 995 are available for seniors above 65 years old."

Answered by AI

Is this medical study currently enrolling participants?

"Based on records available at clinicaltrials.gov, this trial is not accepting applicants. Initially posted in August 1st 2023, the study was last updated a day later and 1331 other trials are open for recruitment currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Impact of Insulin Deprivation and Hyperglycemia on Plasma Protein Synthesis in People With Type 1 Diabetes Mellitus

K. Sreekumaran Nair 2024. "Impact of Insulin Deprivation and Hyperglycemia on Plasma Protein Synthesis in People With Type 1 Diabetes Mellitus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05985135.