Diabetic Gastroparesis, Gastroparesis, Nausea, Vomiting
Conditions
Keywords
gastroparesis, gastric emptying, diabetes, Stomach Diseases, Gastrointestinal Diseases, Digestive System Diseases, Phosphodiesterase Inhibitors, Neurologic Manifestations, Paralysis, Signs and Symptoms, Pharmacologic Actions
Brief summary
The investigators hypothesize that in adult patients with diabetic gastroparesis with Type 1 diabetes (HbA1c ≤ 10.5%), daily tadalafil use will significantly improve gastric emptying compared to baseline as measured by gastric emptying time.
Interventions
DRUGtadalafil
7 days of Cialis for Daily Use (5mg)
Sponsors
Duke University
Eli Lilly and Company
Mark Feinglos
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes diagnosis * Age 18 - 65 years (inclusive) * Hemoglobin A1c ≤ 10.5% within the last 4 months * Diagnosis of gastroparesis, or symptoms consistent with gastroparesis (early satiety, chronic intermittent nausea or vomiting with food intake) * Patient has gastroparesis confirmed on screening study * A female patient is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea, or child-bearing potential with negative serum hCG prior to each gastric emptying study.
Exclusion criteria
* Active nitrate use (e.g. Cialis, Viagra, Levitra, nitroglycerin, Isordil, Imdur, amyl nitrate/poppers) * Fasting fingerstick glucose \> 250 mg/dL * History of abdominal surgery including gastric banding procedure * Patient is on chronic parenteral feeding * Patient has a history of eating disorders (anorexia nervosa, binge eating, bulimia) * Regular opiate use * Recent (last 6 weeks) history of poor control of diabetes e.g. hypoglycemia requiring medical intervention, diabetic ketoacidosis, admission for control diabetes or complications of diabetes * Acute severe gastroenteritis * The patient has participated in another clinical trial in the last 30 days. * Use of medications potentially influencing upper gastrointestinal motility or appetite within one week of the study \[e.g., prokinetic drugs, macrolide antibiotics (erythromycin), GLP-1 mimetics/analog, amylin analog\] * History or presence of clinically significant gastro-intestinal, hepatic or renal disease or other condition that would in the opinion of the investigator make the subject unsuitable for inclusion in this clinical study. * Chronic angina or NYHA class III or IV CHF * Concurrent use of ketoconazole or itraconazole * History of severe vision loss, retinitis pigmentosa, or non-arteritic anterior ischemic optic neuropathy (NAION) * History of CVA * Pregnant females as determined by positive serum hCG test * Lactating females * Uncontrolled hypertension (SBP \> 160 or DBP \> 100) * Hypotension (SBP \< 90 or DBP \< 60) * Other major medical conditions: priapism, sickle cell anemia, multiple myeloma, leukemia, active cancer diagnosis, HIV/AIDS, alcoholism, or bleeding diathesis. * Intolerance to active or inactive ingredients of Cialis, or intolerance to other PDE-5 inhibitors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| improvement in Gastric Emptying Study residual tracer amount | 7 days with intervention | change in gastric emptying compared to baseline as measured by gastric emptying time. |
Countries
United States
Outcome results
None listed