Relationship Between Gastric Emptying and Glycemic Variability in Type 1 Diabetes Mellitus

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

With this study, the investigators hoped to learn if the rate at which food empties from the stomach affects blood sugar values. Using data from this study, we hope to improve our ability to control blood sugars in individuals with type 1 diabetes mellitus.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adil Bharucha
• Treatments: Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin lactobionate; Erythromycin stearate

Criteria

Inclusion Criteria:

• Healthy male or non-pregnant non-breastfeeding female volunteers with type 1 diabetes mellitus (T1 DM) undergoing a clinically-indicated continuous glucose monitoring (CGM) study (Women of childbearing potential may be enrolled if they use contraceptives throughout the length of the study).

• Able to provide written informed consent before participating in the study

• Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

• Glycated hemoglobin (A1c) < 8.5 %

Exclusion Criteria:

• Severe nausea or vomiting precluding study assessments

• Use of medications that alter GI motility e.g., narcotics, medications with significant anticholinergic effects, CYP-450 3A4 inhibitors, antibiotics (other than the experimental drug erythromycin), pramlintide or GLP-1 based therapy. Subjects using metoclopramide or erythromycin will be enrolled but these medications will be held for 7 days before CGM1 and GE1

• Pancreas transplantation

• Contraindications to erythromycin: i.e., 1) concomitant therapy with astemizole, cisapride, pimozide, or terfenadine; 2) hypersensitivity to erythromycin or any component of the product; Corrected QT interval on EKG >460 msec

• Known family history of sudden death or congenital QT prolongation

• Serum potassium and magnesium levels outside of normal range at screening or visit 1

• Patients with moderate or severe renal insufficiency, i.e., subjects with an eGFR < 60 mL/min/1.73 m^2)

• Patients who are allergic to eggs, wheat or milk or unwilling to consume these products.