28 Participants Needed

GLP-1 for Low Blood Sugar

Age: 18 - 65
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Maryland, Baltimore

What You Need to Know Before You Apply

What is the purpose of this trial?

Low blood sugar can negatively affect how blood vessels function, and this can lead to an increase in the risk for heart attacks, strokes and other problems related to the stiffening and blockage of blood vessels. The purpose of this study is to learn if and how glucagon-like peptide-1 (GLP-1; a naturally occurring hormone in the gut) changes the effects that low blood sugar levels have on blood vessels.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is GLP-1 safe for humans?

GLP-1 receptor agonists are generally considered safe with a low risk of causing low blood sugar (hypoglycemia). The most common side effect is nausea, which usually happens at the start of treatment and goes away in 20-60% of people. There are also some concerns about possible effects on the thyroid gland and a controversial link to pancreatitis and cancer.12345

How is the drug GLP-1 unique for treating low blood sugar?

GLP-1 is unique because it acts as an incretin hormone, enhancing insulin response only when blood sugar levels are high, which helps prevent low blood sugar episodes. Unlike other treatments, GLP-1 also slows stomach emptying and reduces appetite, offering additional benefits for managing blood sugar levels.678910

What data supports the effectiveness of the drug GLP-1 for low blood sugar?

GLP-1 is known to lower blood sugar levels in people with type 2 diabetes by helping the body release insulin and reducing the release of glucagon, a hormone that raises blood sugar. It also slows down how quickly food leaves the stomach, which helps control blood sugar spikes after meals.89111213

Who Is on the Research Team?

Davis, Stephen | University of Maryland ...

Stephen N. Davis, MBBS

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

This trial is for adults aged 30-60 with Type 2 Diabetes who have a body mass index over 25 and controlled blood sugar levels (HbA1c between 6-10%). It's also open to healthy individuals in the same age range. People with significant diabetic complications like retinopathy or neuropathy can't participate.

Inclusion Criteria

I am a healthy individual aged 30-60.
I do not have major complications from diabetes like eye or nerve damage.
You weigh more than what is considered healthy for your height.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GLP-1 or saline infusion during the experimental period

4 hours
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Glucagon-Like Peptide-1 (GLP-1)
Trial Overview The study is testing whether GLP-1, a hormone that occurs naturally in the gut, can reduce negative effects of low blood sugar on blood vessels. Participants will receive either GLP-1 infusion or saline as a placebo to compare outcomes.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Glucagon-Like Peptide -1 (GLP-1) infusionActive Control1 Intervention
Group II: Saline InfusionPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials
729
Recruited
540,000+

Published Research Related to This Trial

A review of 120 cases of adverse drug reactions (ADRs) associated with GLP-1 agonists in type 2 diabetes patients revealed that gastrointestinal disorders, especially pancreatitis, were the most frequently reported issues.
Liraglutide and exenatide were found to be the GLP-1 agonists most commonly linked to these adverse reactions, highlighting the need for careful monitoring of patients using these medications.
Adverse drug reactions of GLP-1 agonists: A systematic review of case reports.Shetty, R., Basheer, FT., Poojari, PG., et al.[2022]
GLP-1 receptor agonists, while raising safety concerns about potential links to pancreatitis and tumors, have not shown a significant association with these risks in clinical studies, which often have biases.
Regulatory bodies like the FDA and EMA suggest that current safety concerns should not hinder the use of GLP-1Rx agonists, as they provide important benefits for many patients with diabetes.
Potential side effects to GLP-1 agonists: understanding their safety and tolerability.Consoli, A., Formoso, G.[2018]
GLP-1 receptor agonists (GLP-1ra) effectively lower blood sugar levels with a low risk of hypoglycemia, making them a safe option for diabetes management.
The most common side effect is transient nausea, affecting 20-60% of patients at the beginning of treatment, while concerns about potential links to pancreatitis and cancer are still under investigation.
[Safety and tolerability of GLP-1 receptor agonists].Soldevila, B., Puig-Domingo, M.[2018]

Citations

[Characteristics and types of GLP-1 receptor agonists. An opportunity for individualized therapy]. [2018]
[Characteristics and types of GLP-1 receptor agonists. An opportunity for individualized therapy]. [2015]
3.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Development of glucagon-like peptide-1-based pharmaceuticals as therapeutic agents for the treatment of diabetes. [2019]
[Effects of GLP-1 receptor agonists on carbohydrate metabolism control]. [2018]
[Effects of GLP-1 receptor agonists on carbohydrate metabolism control]. [2022]
Adverse drug reactions of GLP-1 agonists: A systematic review of case reports. [2022]
Potential side effects to GLP-1 agonists: understanding their safety and tolerability. [2018]
[Safety and tolerability of GLP-1 receptor agonists]. [2018]
[Safety and tolerability of GLP-1 receptor agonists]. [2015]
10.United Statespubmed.ncbi.nlm.nih.gov
Safety and Tolerability of Glucagon-Like Peptide-1 Receptor Agonists Utilizing Data from the Exenatide Clinical Trial Development Program. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Incretins and their analogues as new antidiabetic drugs. [2019]
Addition of a cysteine to glucagon-like peptide-1 (GLP-1) conjugates GLP-1 to albumin in serum and prolongs GLP-1 action in vivo. [2018]
The class B G-protein-coupled GLP-1 receptor: an important target for the treatment of type-2 diabetes mellitus. [2020]
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