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GLP1R Agonist
Semaglutide for Type 2 Diabetes (PORT Trial)
Phase 1
Recruiting
Led By Amber L Beitelshees, PharmD
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
Be older than 18 years old
Must not have
Personal or family history of medullary carcinoma of the thyroid or multiple endocrine neoplasia, type 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed after completing 6 weeks of semaglutide therapy
Awards & highlights
Summary
This trial is looking for genetic variants associated with the effects of a GLP1R agonist on insulin secretion and glucose metabolism in overweight/obese, otherwise healthy Amish volunteers.
Who is the study for?
This trial is for overweight or obese individuals of Amish descent with a BMI of 27 kg/m2 or higher. It's not open to women who can have children and are sexually active, people with certain blood, liver, thyroid conditions, kidney issues (eGFR < 60 mL/min/1.73 sq. m.), a personal or family history of specific cancers, known allergy to semaglutide, or those on medications that could affect the study.Check my eligibility
What is being tested?
The trial tests how Semaglutide affects insulin secretion and glucose disappearance in the body by comparing before and after use in participants. It involves genetic testing to find any variants linked to these effects using frequent blood sugar tests over six weeks.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of Semaglutide may include nausea, vomiting, diarrhea, abdominal pain and constipation. There might also be risks associated with frequently sampled intravenous glucose tolerance tests.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I or my family have a history of thyroid cancer or multiple endocrine neoplasia type 2.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed after completing 6 weeks of semaglutide therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed after completing 6 weeks of semaglutide therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Insulin
Rate of glucose disappearance
Second phase insulin secretion
Secondary outcome measures
Weight loss
Other outcome measures
Glucose effectiveness (Sg)
Insulin sensitivity (Si)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Open label administration of semaglutideExperimental Treatment1 Intervention
Semaglutide: 0.25 mg, sc, q.week for 4 weeks followed by 0.5 mg, sc, q.week for 2 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide Pen Injector [Ozempic]
2021
Completed Phase 4
~90
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
695 Previous Clinical Trials
376,431 Total Patients Enrolled
4 Trials studying Diabetes
23,990 Patients Enrolled for Diabetes
Amber L Beitelshees, PharmDPrincipal InvestigatorUniversity of Maryland, Baltimore
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to semaglutide.Your hematocrit level is below 35%.I cannot stop taking a medication or supplement that may affect the study drug.I am a woman who could become pregnant and am sexually active.You weigh more than what is considered healthy for your height.Your thyroid-stimulating hormone (TSH) level is either too low (less than 0.4) or too high (more than 5.5).Your liver enzymes (AST or ALT) are more than double the normal limit.I or my family have a history of thyroid cancer or multiple endocrine neoplasia type 2.You are of Amish descent.Your kidney function is lower than a certain level.You have a history of diabetes with high blood sugar levels.
Research Study Groups:
This trial has the following groups:- Group 1: Open label administration of semaglutide
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.
Diabetes Patient Testimony for trial: Trial Name: NCT05071898 — Phase 1
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