NCT02755064

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Adil Bharucha · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

The study comprised 3 outpatient visits over a period of 11 days. Safety lab test were performed at the screening visit. At each visit, GE was evaluated by 13C-spirulina breath tests. Phase 1: After the baseline assessment (GE1), the second and third GE tests were performed during treatment with intravenous (GE2) and oral erythromycin (GE3) or placebo. Subject arrived fasting at each study visit. Prior to gastric emptying study, there was placement of an intravenous line. Subject continued to take insulin and other medications as usual. Subjects were required to do finger-stick glucose readings 4 times a day or as instructed by their physician. Subjects were provided with a log sheet to keep track of meal times, insulin dosing and times, glucose readings, and activities. Continuous glucose monitoring (CGM) and gastric emptying were evaluated for the duration of the study (11 days) and thrice respectively. GE was evaluated at baseline (GE1) and after randomized to intravenous saline, erythromycin (2 mg/kg) or erythromycin (3 mg/kg). Phase 2: Thereafter, patients were randomized to erythromycin ethyl succinate suspension (250 mg tid) or placebo for a total period of 7 days. GE3 was preferably performed on day 7, after oral erythromycin or placebo was started. An EKG was performed at baseline to identify (and exclude) patients who have contraindications to erythromycin. An EKG was also repeated at the end of the study, i.e., on GE3 for safety. No change to insulin (apart from those that patients do with their self management skills) or other medications was made during this research study.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	Erythromycin lactobionate	In Phase 1 of the study, during the second visit, erythromycin was given as an initial bolus of 0.5 mg/kg over 10 min immediately before the meal. Thereafter, an infusion of 1.5 or 2.5 mg/kg was given over the next 50 min with the same infusion pump. The goal of testing 2 different doses was not to assess dose-related effects but to compare glycemic indices against a spectrum of gastric emptying rates.
DRUG	Placebo IV	In Phase 1 of the study, during the second visit, saline was given as an initial bolus over 10 min immediately before the meal. Thereafter, an infusion of saline was given over the next 50 min with the same infusion pump.
DRUG	[13C]-Spirulina	The subject consumed the test meal containing 13C-Spirulina in no more than 10 minutes. Breath samples were collected at baseline obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points.
DRUG	Erythromycin Ethylsuccinate Suspension	In Phase 2 of the study, subjects randomized to this arm will receive Erythromycin Ethylsuccinate Suspension 250 mg tid orally for a total period of 7 days.
DRUG	Placebo Suspension	In Phase 2 of the study, subjects randomized to this arm will receive an oral placebo prepared to mimic the Erythromycin Ethylsuccinate Suspension for a total period of 7 days.

Timeline

• Start date: 2010-06-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2016-04-28
• Last updated: 2016-04-28

Locations

1 site across 1 country: United States