MedTrace Logo

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

NCT02755064 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-04-28

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

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.

Sponsors & Collaborators

  • Adil Bharucha

    lead OTHER

Principal Investigators

  • Adil E Bharucha, MBBS, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02755064 on ClinicalTrials.gov