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Search / Trial NCT05985135

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

Launched by MAYO CLINIC · Aug 2, 2023

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Continuous Subcutaneous Insulin Infusion Multiple Daily Injections Of Insulin

ClinConnect Summary

This clinical trial is designed to explore how insulin affects the muscles, blood, and overall health in people with Type 1 Diabetes. Researchers aim to learn more about the impact of insulin deprivation (not having enough insulin) and high blood sugar levels on the body. By understanding these effects, the study hopes to improve care for individuals living with this condition.

If you or someone you know has Type 1 Diabetes and is between the ages of 18 and 75, you might be eligible to participate. To join, you would need to be able to give written consent and meet certain health criteria, meaning you shouldn't have severe health issues like heart disease or active kidney problems. Participants will be asked to follow specific guidelines and may undergo tests to help researchers gather important information. This study is not yet recruiting, so it’s a good idea to keep an eye out for when it starts if you’re interested in getting involved.

Gender

ALL

Eligibility criteria

  • 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.

About Mayo Clinic

Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.

Locations

Rochester, Minnesota, United States

Rochester, Minnesota, United States

Patients applied

0 patients applied

Trial Officials

K. Sreekumaran Nair, MD

Principal Investigator

Mayo Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported