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

January 27, 2010 updated by: Profil Institut für Stoffwechselforschung GmbH

A Single Center, Open Study to Evaluate Changes in Serum Electrolytes at Different Glucose Concentrations and Their Impact on a Non-invasive Glucose Monitoring Method

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Non-invasive continuous glucose monitoring is a promising approach in diabetes therapy. It is known that changes in glucose concentration in the skin can be registered by means of optical, spectroscopic measures in subjects with diabetes. The precision of such measures, however, so far has been unsatisfactory.

This study evaluates the changes in skin glucose concentration by means of a non-invasive glucose sensor and compares these to blood glucose concentrations during a glucose clamp. It is also known that with hyperglycemic blood glucose concentrations there is a consecutive hyponatraemia. This study shall evaluate to which extent and how fast serum electrolyte parameters change when establishing a hyperglycaemic blood glucose level. This shall help estimate which impact these changes in electrolytes have on the non-invasive glucose sensor.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Neuss, Germany, 41460
        • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent
  • Age between 18 and 65 years

Exclusion Criteria:

  • Uncontrolled hypertension (diastolic blood pressure > 100 mmHG and/or systolic blood pressure > 180 mmHg)
  • Pregnancy or lactation period for female subjects
  • Serious clinical signs of a liver disease, acute or chronic hepatitis, acute or chronic kidney disease, or ALAT > 2.5 times the upper level of normal values, or serum creatinine > 1.3 mg/dL (women)/1.5 mg/dL (men)
  • Any serious acute illness (at the decision of the investigator), e.g. sepsis, gastric or duodenal ulcer, acute myocardial infarction, acute asthma attack
  • Any other serious chronic illness (at the decision of the investigator), e.g. chronic obstructive pulmonary disease, any kind of cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
plasma ion concentrations (sodium, potassium, chloride, calcium, magnesium) and osmolarity
Time Frame: blood samples every 10 min during baseline, plateau hyperglycemic and final euglycemic phase, every 5 min during increase and decrease of blood glucose
blood samples every 10 min during baseline, plateau hyperglycemic and final euglycemic phase, every 5 min during increase and decrease of blood glucose

Secondary Outcome Measures

Outcome Measure
Time Frame
blood glucose concentration
Time Frame: continuously during glucose clamp
continuously during glucose clamp

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Profil Institut für Stoffwechselforschung GmbH

Collaborators

Pendragon Medical AG Switzerland

Investigators

  • Principal Investigator: Christoph Kapitza, MD, Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion (Actual)

May 1, 2002

Study Completion (Actual)

August 1, 2002

Study Registration Dates

First Submitted

January 27, 2010

First Submitted That Met QC Criteria

January 27, 2010

First Posted (Estimate)

January 28, 2010

Study Record Updates

Last Update Posted (Estimate)

January 28, 2010

Last Update Submitted That Met QC Criteria

January 27, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1-2001-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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