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RecruitingPhase 4

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 weeks
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "We will obtain informed consent, check vital signs, take anthropometric measurements, and draw fasting blood work through an intravenous catheter."
  • "During this visit, the subject will take the final (14th) dose of semaglutide, receive fasting blood work, and receive another mixed meal with subsequent blood draws at several time points over 120 minutes."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how gene differences affect the body's response to semaglutide (Rybelsus), a pill approved to treat type 2 diabetes. It is for adults ages 18–65 with normal blood sugar or prediabetes. Researchers will test blood after a set breakfast before and after 14 days of taking the pill.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18–65.
  • Male or a female who is not pregnant.
  • Able and willing to agree to join the study.
  • Have normal blood sugar or prediabetes (blood sugar above normal but below the diabetes range). The study lists fasting blood sugar of 100–125 mg/dL based on past lab records.

Who can't join

  • Take or plan to take diabetes medicines or other medicines that affect blood sugar, such as steroids, growth hormone, or certain antibiotics.
  • Have a history of trouble absorbing food, weight-loss surgery, celiac disease, gallbladder disease, or pancreatitis (swelling of the pancreas).
  • You or a family member has had medullary thyroid cancer or multiple endocrine neoplasia type 2 (a condition that causes tumors in hormone-making glands).
  • Have low kidney function, with an eGFR test result below 60.
  • Have cirrhosis (liver scarring) or liver blood test levels more than 3 times the upper normal limit.
  • Have food restrictions that keep you from eating the study breakfast.
  • Are pregnant, breastfeeding, or at risk of becoming pregnant.
  • Are taking part in another study that tests a treatment or other intervention during this study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

MA