Studies how genes affect response to oral semaglutide in type 2 diabetes

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 65 whose blood sugar is normal or slightly raised (pre-diabetes). It studies how genes change the response to oral semaglutide.

Age

18 to 65 years

Sex

Men and women who are not pregnant.

Disease stage

Blood sugar between normal and pre-diabetes: fasting glucose of 100-125 mg/dL (5.6–6.9 mmol/L), based on existing lab results in the chart.

Earlier treatment

People cannot join if they take, or plan to take, diabetes medicines or medicines that affect blood sugar, such as glucocorticoids, growth hormone or fluoroquinolones.

Main reasons for not taking part

• Pregnant, nursing, or at risk of becoming pregnant
• History of intestinal malabsorption, bariatric surgery, celiac disease, gallbladder disease or pancreatitis
• Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
• Kidney function eGFR below 60 ml/min/1.73 m2, or cirrhosis, or liver tests (AST or ALT) more than 3x the upper limit of normal
• Diet restrictions that prevent eating the test meal, or taking part in other interventional studies

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 65 years old?YesNo

What the trial wants to find out

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.

The group in the trial

• GLUCOSE-MGH StudyOther group

  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

  Treatment: oral semaglutide and Mixed Meal Tolerance Test (MMTT)