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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05985135
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Muscle Biopsy — PROCEDURE
    Needle muscle biopsy of the outer thigh muscle
  • Jell-O with Amino acids — OTHER
    An amino acid mixture containing 13C6 Lysine isotope label
  • Dextrose — DIETARY_SUPPLEMENT
    Intravenous form of sugar

Study Details

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

Key Dates

Start date
Jun 1, 2026
Status verified
Feb 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Type 1 Diabetes Mellitus (T1DM) Insulin Deprived
    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.
  • Experimental: Type 1 Diabetes Mellitus (T1DM) Insulin Treated
    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.
  • Experimental: Type 1 Diabetes Mellitus (T1DM) Insulin-Treated with Hyperglycemia
    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.
  • Other: Non-Diabetic Controls
    Subjects will have blood draws to monitor glucose levels along with a muscle biopsy following consumption of a Jell-O with Amino acids.
  • Experimental: Diabetes after Total Pancreatectomized (DATP) Insulin Treated
    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.
  • Experimental: Diabetes after Total Pancreatectomized (DATP) Insulin Deprived
    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.

Primary Outcome Measure

Protein synthesis [ Time Frame: Approximately 7 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Mark Pataky, PhD, MS
507-255-8115
Rose Decker
507-255-6770

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