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
Trial Overview
The study investigates the impact of insulin deprivation and high blood sugar on protein synthesis in muscles. Participants will undergo a muscle biopsy, consume Jell-O with amino acids, and receive dextrose.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
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.
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.
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.
Subjects will have blood draws to monitor glucose levels along with a muscle biopsy following consumption of a Jell-O with Amino acids.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Citations
Differential effects of insulin deprivation and systemic ...
Insulin deprivation and hyperglycemia either significantly increased (n = 12) or decreased (n = 12) synthesis rates of 24 of 41 plasma proteins in T1DM compared ...
Protein and Energy Metabolism in Type 1 Diabetes - PMC
In addition, protein metabolism is significantly affected during insulin deprivation. A greater increase in whole-body protein breakdown than protein synthesis ...
Protein Metabolism in Insulin-Dependent Diabetes Mellitus,
Whole-body studies have demonstrated that there are increases in both protein breakdown and protein synthesis during insulin deprivation. Because the magnitude ...
Protein and energy metabolism in type 1 diabetes
Profound metabolic changes occur in people with type 1 diabetes mellitus during insulin deprivation. These include an increase in basal energy expenditure ...
Stepwise Discovery of Insulin Effects on Amino Acid and ...
The semi-maximal effect of insulin in suppressing whole-body protein degradation occurred approximately between 20 and 30 μU/mL of plasma ...
Brain functions and cognition on transient insulin deprivation ...
We limited the insulin deprivation duration for participant safety and due to risk for diabetic ketoacidosis, particularly in the pediatric group, in which ...
7.
diabetesjournals.org
diabetesjournals.org/care/article/46/12/2180/153654/Safety-and-Efficacy-of-Sustained-Automated-InsulinSafety and Efficacy of Sustained Automated Insulin Delivery ...
In adults with T1D at high risk for hypoglycemia, AID reduced the risk for hypoglycemia more than twofold, as quantified by TBR, while improving ...
Automated Insulin Delivery Systems and Glucose ...
Data from a small number of events suggest that AID use may also be associated with an increased risk for diabetic ketoacidosis in a subset of ...
Glucose-Lowering Therapy beyond Insulin in Type 1 ...
However, in the early days of insulin treatment, the clinical outcomes were not as favorable as previously assumed: mortality rates were still almost 50% ...
Automated insulin delivery for safe fasting and exercise ...
The risk of hypoglycemia in patients with T1DM is thought to increase during exercise, due to a glucose shift into skeletal muscles via non-insulin-dependent ...
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