Insulin Deprivation Effects on Protein Synthesis in Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore how insulin affects muscle, blood, and the body in people with Type 1 Diabetes. It involves different groups, including those with and without diabetes, to test how their bodies react when insulin is either given or withheld. Participants will undergo blood draws and a muscle biopsy (a small sample taken from the muscle) to study these effects. People with Type 1 Diabetes who have managed their condition for some time and do not smoke or use illicit substances might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to scientific understanding and potentially improve future diabetes treatments.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants with Type 1 Diabetes should be treated with certain types of insulin delivery methods, like continuous subcutaneous insulin infusion or multiple daily injections, but not with Degludec.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that insulin treatment for people with Type 1 Diabetes is generally safe. Insulin is essential for managing blood sugar levels in these patients. Research shows that different types of insulin, such as automated insulin delivery, can reduce the risk of low blood sugar. However, a serious complication called diabetic ketoacidosis can occur if insulin levels become too low.
Studies have demonstrated that not taking insulin can be dangerous. For safety, any break from insulin is usually kept very short. Stopping insulin can cause high blood sugar and serious conditions like diabetic ketoacidosis, especially in people with Type 1 Diabetes.
Overall, while insulin treatment is generally safe and necessary, not taking insulin carries risks that require careful monitoring.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it's exploring how insulin deprivation affects protein synthesis in people with Type 1 Diabetes and those who have had a total pancreatectomy. Current treatments for Type 1 Diabetes primarily focus on insulin administration to regulate blood sugar. However, this trial is unique because it examines the body's response to insulin deprivation and how it impacts muscle protein synthesis, offering a different perspective on managing diabetes. By studying various groups, including those under insulin deprivation and those maintaining typical insulin levels, researchers aim to gain insights into optimizing diabetes management and potentially improving long-term health outcomes for patients.
What evidence suggests that this trial's treatments could be effective for Type 1 Diabetes?
This trial will compare different insulin treatment strategies in participants with Type 1 Diabetes and those who have undergone total pancreatectomy. Research has shown that insulin plays a key role in managing protein use in people with Type 1 Diabetes. In the trial, some participants will be deprived of insulin, which may cause the body to break down more protein than it builds, potentially leading to muscle loss and other health issues. Other participants will continue their baseline insulin infusion, which helps control blood sugar and supports a healthier protein balance, crucial for maintaining muscle strength and overall health. Additionally, even when blood sugar is high, insulin treatment helps reduce serious complications related to high blood sugar.678910
Who Is on the Research Team?
K. Sreekumaran Nair, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for individuals who can legally consent and have Type 1 Diabetes. It aims to explore how insulin affects various body functions in these patients.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo insulin deprivation or treatment, with blood draws and muscle biopsies following consumption of Jell-O with amino acids
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dextrose
- Jell-O with Amino acids
- Muscle Biopsy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor