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The Role of Phosphodiesterase Inhibitors in Incretin Secretion
Sponsor: National Institute on Aging (NIA)
Summary
Background: The drug Roflumilast (Daliresp) is used to treat Chronic Obstructive Pulmonary Disease (COPD). COPD is a lung disease that makes it difficult to breathe. Studies have shown that this drug decreased the blood sugar of people with type 2 diabetes. Sitagliptin (Januvia) is a medication presently used to treat diabetes. Researchers think that both of these drugs may decrease blood sugar by causing an increase in the hormone GLP-1.This hormone is secreted in the small intestines and stomach and is also known as an incretin. Researchers want to study how these drugs affect blood sugar, insulin, and other hormones in the blood. Objectives: * To study the effects of Roflumilast (Daliresp) and Sitagliptin (Januvia) on blood sugar and insulin. * To better understand GLP-1 and other gut hormones. This may lead to new treatments for type 2 diabetes. Eligibility: * Healthy volunteers age 21 55. * Body Mass Index (BMI) less than 30 Design: -This study will require one screening visit and four study visits, scheduled about 3-weeks apart. Screening visit requires participants to arrive after fasting for 10 hours and have the following: * Medical history, physical exam, height, weight, blood pressure measurements and blood and urine tests. * A 2-hour oral glucose tolerance test (OGTT). Participants will drink an orange-flavored drink containing 75 grams of sugar (300 calories). A blood sample will be taken prior to drinking the beverage and 2-hours later. * An electrocardiogram (EKG) to measure the electrical activity of the heart. * Questionnaires about risk for depression or suicide. Study visits 1to 4: * Participants will arrive the evening prior and blood work will be done to confirm eligibility. They will not eat or drink anything except water starting at 8:00 p.m. * About 6:30 a.m. the following day, an I.V. (small plastic tube) will be placed in an arm vein and used to take 20 blood samples over a period of about 11 hours. * Participants will receive one of the following study medication/placebo groupings in random order: 1. Roflumilast (Daliresp) 500 mcg pill; and 1 placebo pill 2. Sitaglipitin (Januvia) 100 mg pill; and 1 placebo pill 3. Roflumilast (Daliresp) 500 mcg pill; and Sitagliptin (Januvia) 100 mg pill 4. 2 placebo pills * One hour later, they will have a 10-hour mixed meal test (MMT). They will be asked to drink a nutritional shake (Ensure Plus). Blood samples will be taken over the next 10 hours to measure blood sugar, insulin and other hormones. At the end of the test, they will be given a meal. * Participants will answer questions about side effects and symptoms. They will receive a follow-up phone call within 10 days.
Key Details
Gender
All
Age Range
21 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
29
Start Date
2015-02-13
Completion Date
2016-09-19
Last Updated
2026-06-01
Healthy Volunteers
No
Conditions
Interventions
Placebo
mixed meal
Roflumilast/Sitagliptin
Both Roflumilast and Sitagliptin together
Sitagliptin
This is already known to increase GLP-1 \& GIP secretion.
Roflumilast
This is already known to increase GLP-1 \& GIP secretion
Locations (1)
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, United States