Caloric Restriction for Type 2 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
Caloric restriction (and RYGB) improves insulin action and lowers fasting glucose, glucagon and EGP, without changes in postprandial EGP and glucagon concentrations. Caloric restriction also improves hepatic steatosis and lowers fasting AA. These changes may represent restoration of glucagon's hepatic actions. This experiment will determine whether caloric restriction improves glucagon's actions on hepatic amino acid, carbohydrate and lipid metabolism in T2DM in comparison to a baseline experiment performed separately in people with T2DM.
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 diabetes should be managed by diet alone or with oral medications, so you might be able to continue your current oral diabetes medications.
Is caloric restriction for type 2 diabetes safe for humans?
How does the drug Glucagon-like peptide-1 (GLP-1) differ from other treatments for type 2 diabetes?
GLP-1 is unique because it not only stimulates insulin release in response to high blood sugar but also lowers glucagon levels, slows stomach emptying, and reduces appetite, which helps manage blood sugar levels more effectively. Unlike other treatments, GLP-1 analogues are designed to have longer-lasting effects, overcoming the short half-life of natural GLP-1, making them a promising option for type 2 diabetes management.26789
What evidence supports the effectiveness of the drug for type 2 diabetes?
Who Is on the Research Team?
Adrian Vella
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for adults with type 2 diabetes managed by diet or oral medications, having a BMI of at least 28. Participants should be weight-stable without active illnesses, significant past surgeries, severe vascular disease, abnormal thyroid levels, contraindications to MRI scans like metal implants or claustrophobia, low hematocrit levels, or high alcohol consumption.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Caloric Restriction
Participants follow a caloric restriction diet of 900 kcal daily for 6 weeks, monitored by weekly meetings with a dietician
Treatment
Participants undergo a hyperglycemic clamp with 2 doses of glucagon infused
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Glucagon
Glucagon is already approved in European Union, United States, Canada, Japan for the following indications:
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Who Is Running the Clinical Trial?
Adrian Vella
Lead Sponsor