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Glucagon Response Study for Non-alcoholic Fatty Liver Disease
Phase 1 & 2
Recruiting
Research Sponsored by Adrian Vella
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 240 minutes of study
Awards & highlights
No Placebo-Only Group
Summary
This trial is examining whether or not glucagon resistance is caused by obesity, hepatic steatosis, or a combination of the two in people with and without type 2 diabetes.
Who is the study for?
This trial is for adults with obesity, Type 2 Diabetes, or Non-alcoholic Fatty Liver Disease who can consent to participate. It's not suitable for those with a history of certain abdominal surgeries, MRI contraindications like metal implants or claustrophobia, severe anemia (low hematocrit), abnormal thyroid levels (TSH), active illness/malignancy, significant vascular disease symptoms, or high alcohol consumption.
What is being tested?
The study investigates how glucagon—a hormone that affects blood sugar—interacts with liver metabolism in people who are lean and obese and may have Type 2 Diabetes. The focus is on understanding glucagon's role in breaking down amino acids and its relationship with liver fat content.
What are the potential side effects?
While the specific side effects aren't listed here, studies involving hormones like glucagon could potentially affect blood sugar levels and cause reactions at the injection site if applicable.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 240 minutes of study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~240 minutes of study
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of Amino acid catabolism in the presence / absence of glucagon
Secondary study objectives
Effect of Diabetes on amino-acid catabolism
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Obese AdultsExperimental Treatment1 Intervention
We will study 20 subjects on one occasion using a hyperglycemic clamp with 2 doses of glucagon.
Group II: Healthy AdultsExperimental Treatment1 Intervention
We will study 20 subjects on one occasion using a hyperglycemic clamp with 2 doses of glucagon.
Group III: Adults with Type 2 DiabetesExperimental Treatment1 Intervention
We will study 20 subjects on one occasion using a hyperglycemic clamp with 2 doses of glucagon.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Adrian VellaLead Sponsor
8 Previous Clinical Trials
149 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have another active illness or cancer.I have had surgery in my upper stomach area before.I have symptoms from large or small vessel blood disease.
Research Study Groups:
This trial has the following groups:- Group 1: Adults with Type 2 Diabetes
- Group 2: Healthy Adults
- Group 3: Obese Adults
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.