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Changes in Serum Electrolytes at Different Glucose Concentrations + Impact on a Non-invasive Glucose Monitoring Method

NCT01058577 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2010-01-28

No results posted yet for this study

Summary

In healthy subjects: Continuous monitoring of the glucose concentration in the skin by means of a non-invasive glucose sensor during a glucose clamp when systematically changing the blood glucose concentration (e.g. to hyperglycemia). Simultaneous frequent determinations of serum electrolytes.

Conditions

Interventions

DEVICE

Non-invasive CGMS

A non-invasive continuous glucose monitoring device measured was applied at the wrist and measured skin glucose as an indirect measure of blood glucose every 10 min.

PROCEDURE

Hyperglycemic glucose clamp

The automated glucose clamp technique was used to control glucose levels at baseline glycemia for 1h, hyperglycemia (16.7 mmol/L) for at least 2.5h and euglycemia (5 mmol/L) for another 2.5h. A continuous somatostatin infusion was initiated after 1h to suppress endogenous insulin secretion. A glucose solution was infused to increase the blood glucose towards the hyperglycemic target level. At approximately t=3.5h the somatostatin infusion was stopped and blood glucose was controlled at the euglycemic target level.

Sponsors & Collaborators

  • Pendragon Medical AG Switzerland

    collaborator UNKNOWN

  • Profil Institut für Stoffwechselforschung GmbH

    lead INDUSTRY

Principal Investigators

  • Christoph Kapitza, MD · Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-12-31
Primary Completion
2002-05-31
Completion
2002-08-31

Countries

  • Germany

Study Locations

More Related Trials

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 NCT01058577 on ClinicalTrials.gov