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Completed

NCT Number: NCT01058577

Changes in Serum Electrolytes at Different Glucose Concentrations + 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive CGMS

Device

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.

Other names: PendraWatch

Hyperglycemic glucose clamp

Procedure

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.

Other names: Biostator, Somatostatin

Primary outcomes

  1. 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

Secondary outcomes

  1. blood glucose concentration

    Time frame: continuously during glucose clamp

Sponsors and collaborators

Lead sponsor

Profil Institut für Stoffwechselforschung GmbH

Industry

Collaborators

  • Pendragon Medical AG Switzerland

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
Jan 28, 2010
Registry last updated
Jan 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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