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GLP-1 Receptor Agonist
GLP-1 for Type 1 Diabetes
Phase < 1
Recruiting
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
40 (20 males, 20 females) individuals with type 1 diabetes aged 18-50 yr.
No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc)
Must not have
Subjects unable to give voluntary informed consent
Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial will test whether GLP-1 can help protect against the harmful effects of hypoglycemia in people with T1DM.
Who is the study for?
This trial is for adults aged 18-50 with Type 1 Diabetes, a BMI under 40kg/m2, and HbA1c levels below 11.0%. Participants should not have diabetic complications like retinopathy or neuropathy. They must not be pregnant, have significant heart issues, severe liver or kidney problems, anemia, or be on certain medications like beta blockers or anticoagulants.
What is being tested?
The study tests if Glucagon-like peptide-1 (GLP-1) can protect blood vessel function and reduce the risk of blood clots after low blood sugar events in people with Type 1 Diabetes. Some participants will receive GLP-1 while others will get a placebo to compare effects.
What are the potential side effects?
Possible side effects of GLP-1 may include digestive issues such as nausea and vomiting, potential allergic reactions, headache, dizziness and might affect blood sugar levels which need careful monitoring.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 50 years old with type 1 diabetes.
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I do not have complications from diabetes like eye or nerve problems.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unable to understand and give consent for my own treatment.
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I am on blood thinners, have anemia, or a bleeding disorder.
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I am not taking medications like beta blockers, sedatives, or antidepressants.
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I am unable or unwilling to follow the required contraception guidelines.
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I do not have uncontrolled high blood pressure or a history of severe heart or brain blood vessel problems.
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I do not have serious heart problems.
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I have pneumonia.
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I do not have liver failure or jaundice.
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I have recently had a stroke or brain injury.
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I have had a fever over 38.0 C.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: GLP-1Experimental Treatment1 Intervention
The participants will be randomized to Glucagon-like peptide-1 infusion.
Group II: Placebo 1Placebo Group1 Intervention
The participants will be randomized to placebo infusion.
Group III: Placebo 2Placebo Group1 Intervention
The participants will be randomized to placebo infusion.
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
713 Previous Clinical Trials
379,595 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable or unwilling to follow the required contraception guidelines.I have recently had a stroke or brain injury.Your liver function tests show levels of SGOT and SGPT that are more than twice the normal range.I do not have uncontrolled high blood pressure or a history of severe heart or brain blood vessel problems.I am not taking medications like beta blockers, sedatives, or antidepressants.I do not have serious heart problems.Your alkaline phosphatase levels are higher than 150 units per liter.Your liver enzyme levels are more than twice the normal range.Your body mass index is less than 40.Your hematocrit level is lower than 32.Your creatinine levels are higher than 1.6 mg/dl.I have had a fever over 38.0 C.Your HbA1c level is below 11.0%.I am unable to understand and give consent for my own treatment.I do not have liver failure or jaundice.You have important abnormal results from screening tests and physical exams.I do not have complications from diabetes like eye or nerve problems.I am between 18 and 50 years old with type 1 diabetes.Your total bilirubin level is higher than 2 mg/dl.Your white blood cell count is below 3 thousand per microliter or above 14 thousand per microliter.I have pneumonia.I am on blood thinners, have anemia, or a bleeding disorder.
Research Study Groups:
This trial has the following groups:- Group 1: GLP-1
- Group 2: Placebo 1
- Group 3: Placebo 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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