NCT05985135

Brief Summary

This research is being done to better understand how insulin effects muscle, blood, and the body in people with Type 1 Diabetes.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
26mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
2.8 years until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2.2 years

First QC Date

August 2, 2023

Last Update Submit

February 25, 2026

Conditions

Type 1 Diabetes

Keywords

Continuous subcutaneous insulin infusionMultiple daily injections of insulin

Outcome Measures

Primary Outcomes (1)

  • Protein synthesis

    Measurement of isotope abundance in peptides derived from the digested proteins

    Approximately 7 hours

Study Arms (6)

Type 1 Diabetes Mellitus (T1DM) Insulin Deprived

EXPERIMENTAL

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.

Procedure: Muscle BiopsyOther: Jell-O with Amino acids

Type 1 Diabetes Mellitus (T1DM) Insulin Treated

EXPERIMENTAL

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.

Procedure: Muscle BiopsyOther: Jell-O with Amino acids

Type 1 Diabetes Mellitus (T1DM) Insulin-Treated with Hyperglycemia

EXPERIMENTAL

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.

Procedure: Muscle BiopsyOther: Jell-O with Amino acidsDietary Supplement: Dextrose

Non-Diabetic Controls

OTHER

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

Procedure: Muscle BiopsyOther: Jell-O with Amino acids

Diabetes after Total Pancreatectomized (DATP) Insulin Treated

EXPERIMENTAL

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.

Procedure: Muscle BiopsyOther: Jell-O with Amino acids

Diabetes after Total Pancreatectomized (DATP) Insulin Deprived

EXPERIMENTAL

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.

Procedure: Muscle BiopsyOther: Jell-O with Amino acids

Interventions

Muscle BiopsyPROCEDURE

Needle muscle biopsy of the outer thigh muscle

Diabetes after Total Pancreatectomized (DATP) Insulin DeprivedDiabetes after Total Pancreatectomized (DATP) Insulin TreatedNon-Diabetic ControlsType 1 Diabetes Mellitus (T1DM) Insulin DeprivedType 1 Diabetes Mellitus (T1DM) Insulin TreatedType 1 Diabetes Mellitus (T1DM) Insulin-Treated with Hyperglycemia
Jell-O with Amino acidsOTHER

An amino acid mixture containing 13C6 Lysine isotope label

Diabetes after Total Pancreatectomized (DATP) Insulin DeprivedDiabetes after Total Pancreatectomized (DATP) Insulin TreatedNon-Diabetic ControlsType 1 Diabetes Mellitus (T1DM) Insulin DeprivedType 1 Diabetes Mellitus (T1DM) Insulin TreatedType 1 Diabetes Mellitus (T1DM) Insulin-Treated with Hyperglycemia
DextroseDIETARY_SUPPLEMENT

Intravenous form of sugar

Type 1 Diabetes Mellitus (T1DM) Insulin-Treated with Hyperglycemia

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Able to provide written consent.

You may not qualify if:

  • BMI \< 20 or \> 32 kg/m\^2.
  • Celiac disease.
  • Pregnancy.
  • Smoking.
  • Reported history of illicit substance use.
  • History of active cardiovascular, cerebrovascular, or peripheral vascular disease.
  • Active renal disease evidenced by estimated glomerular filtration rate (GFR) \< 50 mL/min/1.73 m\^2.
  • Severe peripheral or autonomic neuropathy.
  • Dementia or any other neurologic disease.
  • Uncontrolled psychiatric disease.
  • Any learning disability.
  • Anemia.
  • Thyroid-stimulating hormone (TSH) ≥ 7 or TSH ≤ 7 and free T4 ≤ 0.9.
  • Hemoglobin A1c \> 9.0%.
  • Type 2 Diabetes Mellitus (T2DM), or impaired fasting glucose.
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

GelsAmino AcidsGlucose

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical PreparationsAmino Acids, Peptides, and ProteinsHexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • K. Sreekumaran Nair, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Pataky, PhD, MS

CONTACT

507-255-8115pataky.mark@mayo.edu

Rose Decker

CONTACT

507-285-6770bilderback.rose@mayo.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 2, 2023

First Posted

August 14, 2023

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)