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GLP-1 Receptor Agonist

GLUCOSE-MGH Study for Metabolic Diseases (GLUCOSE-MGH Trial)

Phase 4

Recruiting

Led By Josephine Li, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 120 minutes during visit 1

Awards & highlights

GLUCOSE-MGH Trial Summary

This trial aims to understand how genetic differences affect the way the body responds to a medication called oral semaglutide, commonly used to treat diabetes and obesity. Participants will have their blood tested before and

Who is the study for?

This trial is for adults aged 18-50 who can consent and have blood sugar levels indicating they are between normal health and pre-diabetes. It's not suitable for pregnant individuals or those outside the age range.Check my eligibility

What is being tested?

The study tests how genetic differences affect responses to Rybelsus, a diabetes/obesity drug, by analyzing blood factors after a standard meal before and after two weeks of taking the drug.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones for Rybelsus may include stomach pain, nausea, diarrhea, weight loss, and potential changes in blood sugar levels.

GLUCOSE-MGH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 120 minutes during visit 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~120 minutes during visit 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 minutes during visit 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Insulin response to oral semaglutide treatment

Secondary outcome measures

Baseline incretin level

Cumulative glucose response to oral semaglutide treatment

Fasting glucose response to oral semaglutide treatment

GLUCOSE-MGH Trial Design

1Treatment groups

Experimental Treatment

Group I: GLUCOSE-MGH StudyExperimental Treatment2 Interventions

Day 1: Mixed meal tolerance test Day 3-15: 7 mg oral semaglutide, once daily Day 16: 1 dose of 7 mg oral semaglutide, Mixed meal tolerance test in the presence of semaglutide

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,467 Total Patients Enrolled

27 Trials studying Metabolic Diseases

6,110 Patients Enrolled for Metabolic Diseases

Massachusetts General HospitalLead Sponsor

2,935 Previous Clinical Trials

13,198,516 Total Patients Enrolled

6 Trials studying Metabolic Diseases

471 Patients Enrolled for Metabolic Diseases

Josephine Li, MDPrincipal InvestigatorMGH

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for potential participants in this research study?

"As per clinicaltrials.gov, this trial is actively seeking participants. It was initially posted on March 12th, 2024, with the most recent update made on March 22nd of the same year."

Answered by AI

Which individuals meet the criteria for eligibility to participate in this research endeavor?

"The research seeks 125 individuals aged between 18 to 50 with metabolic disorders. Essential requirements include being within the specified age range, capable of providing informed consent, falling within the spectrum from normal glycemia to pre-diabetes based on existing lab results (fasting glucose levels ranging from 100-125 mg/dL), and identification as male or non-pregnant female."

Answered by AI

What is the number of individuals currently undergoing treatment within this medical study?

"Affirmative. Information from clinicaltrials.gov indicates that this investigation is currently seeking participants. The trial was initially listed on March 12, 2024, and the most recent update was made on March 22, 2024. This study aims to enroll 125 patients at a single site."

Answered by AI

Is there an age restriction for participation in this medical study, particularly with regards to individuals over 45 years old?

"Eligible candidates for this research study must be aged between 18 and 50. Notably, there are a total of 57 clinical trials tailored to individuals under 18 years old and 464 studies catering to those over the age of 65."

Answered by AI

Does the GLUCOSE-MGH research study have approval from the FDA?

"Given that the GLUCOSE-MGH Study is a Phase 4 trial, our team at Power rates its safety as a 3 on our scale. This rating reflects that the treatment has already obtained regulatory approval."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH

Josephine Li, MD 2024. "GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06003153.