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 — PROCEDURENeedle muscle biopsy of the outer thigh muscle
- Jell-O with Amino acids — OTHERAn amino acid mixture containing 13C6 Lysine isotope label
- Dextrose — DIETARY_SUPPLEMENTIntravenous 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 DeprivedSubjects 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 TreatedSubjects 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 HyperglycemiaSubjects 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 ControlsSubjects 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 TreatedSubjects 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 DeprivedSubjects 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
- Mark Pataky, PhD, MS507-255-8115
- Rose Decker507-285-6770
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 |
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