20 Participants Needed

Caloric Restriction for Type 2 Diabetes

JL
Overseen ByJeanette Laugen
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Adrian Vella
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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?

The safety of glucagon-like peptide-1 (GLP-1) analogues, which are related to glucagon, has been studied for type 2 diabetes. These treatments are generally safe and help control blood sugar by stimulating insulin and reducing appetite, but they are not the same as glucagon itself.12345

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?

Research shows that GLP-1 analogues, which are similar to glucagon, help control blood sugar levels in people with type 2 diabetes by increasing insulin release and reducing glucagon levels. They also help with weight loss and have a low risk of causing low blood sugar.13101112

Who Is on the Research Team?

AV

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

I have type 2 diabetes and my weight has been stable.
You weigh more than what's considered healthy for your height.
My diabetes is controlled by diet or oral medications.

Exclusion Criteria

You drink more than 2 alcoholic drinks a day or more than 14 drinks a week, or you have a positive AUDIT questionnaire.
Your hematocrit level is less than 35%.
I have an active illness or another cancer.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Caloric Restriction

Participants follow a caloric restriction diet of 900 kcal daily for 6 weeks, monitored by weekly meetings with a dietician

6 weeks
6 visits (virtual or in-person)

Treatment

Participants undergo a hyperglycemic clamp with 2 doses of glucagon infused

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Glucagon
Trial Overview The study examines how caloric restriction affects liver metabolism in people with type 2 diabetes. It will compare the body's response to glucagon—a hormone that raises blood sugar—before and after participants restrict their calorie intake.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Adults with type 2 diabetesExperimental Treatment2 Interventions

Glucagon is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as GlucaGen for:
🇺🇸
Approved in United States as Glucagon for:
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Approved in Canada as Glucagon Novo Nordisk for:
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Approved in Japan as Glucagon Lilly for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Adrian Vella

Lead Sponsor

Trials
9
Recruited
210+

Published Research Related to This Trial

GLP-1 analogues effectively lower HbA1c levels by about 1% in patients with type 2 diabetes who are not achieving satisfactory control with oral medications, based on a systematic review of 28 randomized controlled trials.
These medications also promote significant weight loss (between 2.3 to 5.5 kg) compared to other treatments, with a low incidence of hypoglycemia, making them a safe and effective option for managing diabetes.
Glucagon-like peptide analogues for type 2 diabetes mellitus: systematic review and meta-analysis.Shyangdan, DS., Royle, PL., Clar, C., et al.[2022]
GLP-1-based therapies for type 2 diabetes, including GLP-1 receptor agonists and DPP-4 inhibitors, effectively lower HbA1c levels by approximately 0.8-1.1% over 12 weeks, demonstrating their efficacy as both monotherapy and in combination with other diabetes medications.
These therapies not only improve glycemic control but also have a low risk of adverse events, including hypoglycemia, making them a safe treatment option, particularly beneficial when combined with metformin for patients not adequately controlled by metformin alone.
GLP-1 for type 2 diabetes.Ahrén, B.[2015]
GLP-1 receptor analogues (GLP-1RAs) are effective treatments for type 2 diabetes, improving blood sugar control and weight management while having a low risk of hypoglycemia.
These medications work by increasing insulin secretion and reducing glucagon release in a glucose-dependent manner, and they are generally well tolerated, with gastrointestinal issues being the most common side effects.
Glucagon-Like Peptide-1 Receptor Analogues in Type 2 Diabetes: Their Use and Differential Features.Lyseng-Williamson, KA.[2022]

Citations

Glucagon-like peptide analogues for type 2 diabetes mellitus: systematic review and meta-analysis. [2022]
GLP-1 for type 2 diabetes. [2015]
Glucagon-Like Peptide-1 Receptor Analogues in Type 2 Diabetes: Their Use and Differential Features. [2022]
Incretins and other peptides in the treatment of diabetes. [2018]
Glucagon-like peptide analogues for type 2 diabetes mellitus. [2023]
Glucagon-like peptide 1 (GLP-1) as a new therapeutic approach for type 2-diabetes. [2018]
Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. [2022]
[Glucagon-like peptides--synthesis, biological actions and some clinical implications]. [2006]
Glucagon-like peptide 1 (GLP-1): a potent gut hormone with a possible therapeutic perspective. [2019]
18F-radiolabeled analogs of exendin-4 for PET imaging of GLP-1 in insulinoma. [2022]
Synthesis, secretion and biological actions of the glucagon-like peptides. [2004]
The entero-insular axis in type 2 diabetes--incretins as therapeutic agents. [2006]
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