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Tadalafil and Gastroparesis
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We hypothesize that in adult patients with diabetic gastroparesis with established Type 1 diabetes (HbA1c ≤ 10.0%), 7 days of daily tadalafil use will significantly improve gastric emptying compared to baseline as measured by gastric emptying time.
This open-label study will be performed on up to 20 adults (age 18 to 50 years) with symptomatic diabetic gastroparesis confirmed on baseline gastric emptying scans, despite moderately well-controlled type 1 diabetes.
Those who meet the criteria will be asked to provide consent in person in a private setting at Duke Medical Center. The subjects will then be asked to come to Duke Clinical Research Unit for Visit 1 (Day 0) in the morning after an 8 hour fast.
During Visit 1, subjects will have their vital signs, height, weight, current medications, and fasting blood glucose (by fingerstick measurement) recorded. For women of child-bearing potential, rapid quantatative serum hCG will be performed to confirm non-pregnant state. All qualified subjects will then undergo a standard 4 hour gastric emptying study after self-injecting usual prandial dose insulin and ingesting the standard test meal. After the result is back confirming quantifiable gastroparesis, the qualified subject will be provided with his or her weekly supply of study drug (5 mg per day tadalafil tablet), first dose to be taken the next day (Day 1).
During Visit 2 (Day 7 ± 1), concomitant medication list will be updated and any side effects of the study drug will be gathered. Compliance to study drug is calculated and subject will need ≥ 85% compliance to continue. Vital signs and weight will be recorded. The subject is verified to have fasted overnight for 8 hours and again fasting blood glucose is recorded. For women of child-bearing potential, rapid quantitative serum hCG will be performed to confirm non-pregnant state. All qualified subjects will then undergo a standard 4 hour gastric emptying study after self- injecting usual prandial dose insulin and ingesting the standard test meal.
There will be no financial costs to the subjects who enroll in the study. Study-related costs will be covered by Dr. Feinglos’ research funds and by a grant from Duke Clinical Research Unit. Study drug will be supplied by Lilly. Parking passes will be provided. There will be no monetary compensation provided to participants.
(REF# 00037289)
This open-label study will be performed on up to 20 adults (age 18 to 50 years) with symptomatic diabetic gastroparesis confirmed on baseline gastric emptying scans, despite moderately well-controlled type 1 diabetes.
Those who meet the criteria will be asked to provide consent in person in a private setting at Duke Medical Center. The subjects will then be asked to come to Duke Clinical Research Unit for Visit 1 (Day 0) in the morning after an 8 hour fast.
During Visit 1, subjects will have their vital signs, height, weight, current medications, and fasting blood glucose (by fingerstick measurement) recorded. For women of child-bearing potential, rapid quantatative serum hCG will be performed to confirm non-pregnant state. All qualified subjects will then undergo a standard 4 hour gastric emptying study after self-injecting usual prandial dose insulin and ingesting the standard test meal. After the result is back confirming quantifiable gastroparesis, the qualified subject will be provided with his or her weekly supply of study drug (5 mg per day tadalafil tablet), first dose to be taken the next day (Day 1).
During Visit 2 (Day 7 ± 1), concomitant medication list will be updated and any side effects of the study drug will be gathered. Compliance to study drug is calculated and subject will need ≥ 85% compliance to continue. Vital signs and weight will be recorded. The subject is verified to have fasted overnight for 8 hours and again fasting blood glucose is recorded. For women of child-bearing potential, rapid quantitative serum hCG will be performed to confirm non-pregnant state. All qualified subjects will then undergo a standard 4 hour gastric emptying study after self- injecting usual prandial dose insulin and ingesting the standard test meal.
There will be no financial costs to the subjects who enroll in the study. Study-related costs will be covered by Dr. Feinglos’ research funds and by a grant from Duke Clinical Research Unit. Study drug will be supplied by Lilly. Parking passes will be provided. There will be no monetary compensation provided to participants.
For more information, contact Kathryn Evans at 919-684-3758.
(REF# 00037289)
