Status:
NOT_YET_RECRUITING
Impact of Insulin Deprivation and Hyperglycemia on Plasma Protein Synthesis in People With Type 1 Diabetes Mellitus
Lead Sponsor:
Mayo Clinic
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This research is being done to better understand how insulin effects muscle, blood, and the body in people with Type 1 Diabetes.
Detailed Description
Insulin's contribution in controlling glucose homeostasis has been well appreciated but, its role in maintaining proteome homeostasis is less understood. Some animal and human studies have demonstrate...
Eligibility Criteria
Inclusion
- Inclusion Criteria - Type 1 Diabetes Group:
- \- Able to provide written consent.
- Exclusion Criteria - Type 1 Diabetes Group::
- 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.
- Detectable C peptide.
- Inclusion Criteria - Control Group:
- Able to provide written consent.
- T1DM treated with continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI) (not Degludec).
- Exclusion Criteria - Control Group:
- 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 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.
- TSH ≥ 7 or TSH ≤ 7 and free T4 ≤ 0.9.
- T2DM, or impaired fasting glucose.
Exclusion
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05985135
Start Date
December 1 2025
End Date
August 1 2028
Last Update
June 4 2025
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905