GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH
Study explores how genes affect response to oral diabetes medication
Plain English Summary
GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH is a Phase 4 clinical trial sponsored by Massachusetts General Hospital studying Genetic Predisposition, Metabolic Diseases, Type 2 Diabetes. This study tests how genetic differences influence how people respond to oral semaglutide, a common type 2 diabetes medication. It is for adults aged 18-65 who have pre-diabetes or normal blood sugar levels and are not currently taking diabetes medications. Participants will take oral semaglutide for 14 days and undergo blood tests after eating a standardized meal before and after treatment. Alternatives include standard diabetes management and other medications prescribed by a doctor. The trial aims to enroll 125 participants.
Official Summary
The goal of this research study is to evaluate the pathophysiologic mechanisms by which genetic variation impacts response to an FDA-approved medication commonly used to treat type 2 diabetes called oral semaglutide (Rybelsus) and to characterize the physiological response to a mixed meal tolerance test (MMTT) before and after a 14-day treatment with oral semaglutide. The investigators will do this by measuring factors in the blood, such as sugars, fats, metabolites, and proteins, after eating a standardized breakfast meal at the first visit and after taking 14 doses of oral semaglutide over two weeks before the second study visit. The food (mixed meal breakfast) we will be studying is specially prepared to contain a set amount of protein, carbohydrates, and fat. The investigators hypothesize that understanding how the acute biochemical response to oral semaglutide differs by genetic variation will generate insight into drug mechanisms and type 2 diabetes pathophysiology.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are male or female (not pregnant), aged 18-65, and have blood sugar levels between normal and pre-diabetic. You cannot join if you are currently taking diabetes medications or medications that affect blood sugar, have a history of certain digestive issues, or have a personal/family history of specific thyroid cancers. You also cannot join if you have kidney disease, liver problems, or dietary restrictions that prevent you from eating a specific meal. This trial is studying Genetic Predisposition, Metabolic Diseases, Type 2 Diabetes, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how your body's insulin production changes after taking oral semaglutide, helping to understand how the drug works in your body. The specific primary outcome measures are: Insulin response to oral semaglutide treatment (15 days). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.
Why This Trial Matters
This trial is important because it aims to understand why some people respond better than others to a widely used diabetes drug, potentially leading to more personalized treatments. This research targets Genetic Predisposition, Metabolic Diseases, Type 2 Diabetes, where improved treatment options are needed.
Investor Insight
This trial focuses on a key medication for type 2 diabetes, a condition affecting millions, and seeks to uncover genetic insights that could refine treatment strategies. This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes.
Is This Trial Right for Me?
Ask your doctor if this study is right for you, especially regarding your current health and any medications you take. Participation involves taking a daily pill (oral semaglutide) for two weeks and attending two study visits for blood tests after eating a special meal. The study will monitor your blood for sugars, fats, and other substances to see how your body reacts to the medication and meal. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 125 participants
Interventions
- DRUG: oral semaglutide — Semaglutide is the only oral glucagon-like peptide 1 receptor agonist (GLP-1 RA) approved for treatment of type 2 diabetes. Participants will receive 7 mg of oral semaglutide once daily for 14 days in between Visit 1 and Visit 2.
- OTHER: Mixed Meal Tolerance Test (MMTT) — The MMTT is developed by the Metabolism and Nutrition Metabolic Kitchen at the MGH TCRC. The meal is a high-calorie, high-carbohydrate and moderate-to-high glycemic index challenge composed of commonly consumed breakfast food items. It provides nearly 90 grams of carbohydrates and mimics an oral glucose challenge. The participants will undergo a MMTT at Visit 1 and Visit 2.
Primary Outcomes
- Insulin response to oral semaglutide treatment (15 days)
Secondary Outcomes
- Fasting glucose response to oral semaglutide treatment (15 days)
- Cumulative glucose response to oral semaglutide treatment (15 days)
- Baseline incretin level (120 minutes during Visit 1)
Full Eligibility Criteria
Inclusion Criteria: 1. Males or non-pregnant females 2. Ages 18-65 (inclusive) 3. Able/willing to give consent 4. Span the metabolic range between normal glycemia and pre-diabetes (fasting glucose of 100-125 mg/dL based on chart review of existing laboratory data) Exclusion Criteria: 1. Currently taking medications or intending to take medications for diabetes 2. Currently taking medications or intending to take medications that affect glycemic parameters, such as glucocorticoids, growth hormone, or fluoroquinolones 3. Personal history of intestinal malabsorption, bariatric surgery, celiac disease, gallbladder disease, or pancreatitis 4. Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 5. Estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73 m2 per the Modification of Diet in Renal Disease equation 6. History of cirrhosis and/or aspartate aminotransferase or alanine aminotransferase more than 3x upper limit of normal 7. Dietary restrictions preventing consumption of a MMTT 8. Women who are pregnant, nursing, or at risk of becoming pregnant 9. Participation in other interventional studies during the current study
Trial Locations
- Massachusetts General Hospital, Boston, Massachusetts, United States
Frequently Asked Questions
What is clinical trial NCT06003153?
NCT06003153 is a Phase 4 INTERVENTIONAL study titled "GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH." It is currently recruiting and is sponsored by Massachusetts General Hospital. The trial targets enrollment of 125 participants.
What conditions does NCT06003153 study?
This trial investigates treatments for Genetic Predisposition, Metabolic Diseases, Type 2 Diabetes. The primary condition under study is Genetic Predisposition.
What treatments are being tested in NCT06003153?
The interventions being studied include: oral semaglutide (DRUG), Mixed Meal Tolerance Test (MMTT) (OTHER). Semaglutide is the only oral glucagon-like peptide 1 receptor agonist (GLP-1 RA) approved for treatment of type 2 diabetes. Participants will receive 7 mg of oral semaglutide once daily for 14 days in between Visit 1 and Visit 2.
What does Phase 4 mean for NCT06003153?
Phase 4 trials occur after a treatment is already approved and on the market. They monitor long-term effectiveness and safety in larger populations under real-world conditions.
What is the current status of NCT06003153?
This trial is currently "Recruiting." It started on 2024-03-12. The estimated completion date is 2027-05-31.
Who is sponsoring NCT06003153?
NCT06003153 is sponsored by Massachusetts General Hospital. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06003153?
The trial aims to enroll 125 participants. The trial is currently recruiting and accepting new participants.
How is NCT06003153 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT06003153?
The primary outcome measures are: Insulin response to oral semaglutide treatment (15 days). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06003153 being conducted?
This trial is being conducted at 1 site, including Boston, Massachusetts (United States).
Where can I find official information about NCT06003153?
The official record for NCT06003153 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06003153. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06003153 testing in simple terms?
This study tests how genetic differences influence how people respond to oral semaglutide, a common type 2 diabetes medication. It is for adults aged 18-65 who have pre-diabetes or normal blood sugar levels and are not currently taking diabetes medications.
Why is this trial significant?
This trial is important because it aims to understand why some people respond better than others to a widely used diabetes drug, potentially leading to more personalized treatments.
What are the potential risks of participating in NCT06003153?
The most common side effects of oral semaglutide can include nausea, vomiting, diarrhea, and stomach pain. There is a small risk of more serious side effects like pancreatitis or gallbladder problems, though these are rare. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06003153?
Ask your doctor if this study is right for you, especially regarding your current health and any medications you take. Participation involves taking a daily pill (oral semaglutide) for two weeks and attending two study visits for blood tests after eating a special meal. The study will monitor your blood for sugars, fats, and other substances to see how your body reacts to the medication and meal. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06003153 signal from an investment perspective?
This trial focuses on a key medication for type 2 diabetes, a condition affecting millions, and seeks to uncover genetic insights that could refine treatment strategies. This is a Phase 4 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will take oral semaglutide for 14 days and undergo blood tests after eating a standardized meal before and after treatment. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.