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

NCT ID: NCT01058577

Last Updated: 2010-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2002-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus

Keywords

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diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Other Intervention Names

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PendraWatch Biostator Somatostatin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pendragon Medical AG Switzerland

UNKNOWN

Sponsor Role collaborator

Profil Institut für Stoffwechselforschung GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

Principal Investigators

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Christoph Kapitza, MD

Role: PRINCIPAL_INVESTIGATOR

Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

Locations

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Profil Institut für Stoffwechselforschung GmbH

Neuss, , Germany

Site Status

Countries

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Germany

Other Identifiers

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B1-2001-01

Identifier Type: -

Identifier Source: org_study_id