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Effect of Glucose on QTc Interval in Type 1 Diabetes

NCT01984827 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-05-05

No results posted yet for this study

Summary

High blood glucose levels (hyperglycaemia) and Moxifloxacin (a commonly used antibiotic) have both been shown independently to affect heart activity in healthy volunteers as recorded by ECG. i.e. Both cause prolongation of the QTc interval which is a measure of the time between the start of the Qwave and the end of the Twave during a heartbeat cycle. In this study, the investigators want to find out whether moxifloxacin and hyperglycaemia cause QTc prolongation in Type 1 diabetic patients. The investigators also want to assess whether C-peptide (a fragment if insulin normally found in the blood but not present in the blood of Type 1 diabetics) has the opposite effect on heart activity i.e it shortens the QTc interval will reverse the effect of QTc prolongation in Type 1 diabetes as this may be useful for preventing 'dead in bed' syndrome also known as 'Sudden Cardiac Death' which is more common in diabetic patients compared to healthy volunteers.

Conditions

Interventions

DRUG

Moxifloxacin

1. a single oral dose of 400mg Moxifloxacin plus a hyper-glycaemic clamp for 4 hours 2. a single oral dose of 400mg Moxifloxacin plus C-peptide 3. a single oral dose of 400mg Moxifloxacin 4. placebo Oral doses of placebo and moxifloxacin will be administered by a Research Physician or Pharmacy staff member between 08:00 a.m. and 10:00 a.m.

OTHER

hyper-glycaemic clamp

a hyper-glycaemic clamp only for 2 hours followed by a hyper-glycaemic clamp plus C-peptide for 2 hours

Sponsors & Collaborators

  • Richmond Pharmacology Limited

    collaborator INDUSTRY

  • Richmond Research Institute

    lead INDUSTRY

Principal Investigators

  • Jorg Taubel, MD FFPM · Richmond Pharmacology Limited

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-10
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

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 NCT01984827 on ClinicalTrials.gov