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

This study has been completed.
Sponsor:
Collaborator:
Pendragon Medical AG Switzerland
Information provided by:
Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier:
NCT01058577
First received: January 27, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Device: Non-invasive CGMS
Procedure: Hyperglycemic glucose clamp
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Profil Institut für Stoffwechselforschung GmbH:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • blood glucose concentration [ Time Frame: continuously during glucose clamp ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: December 2001
Study Completion Date: August 2002
Primary Completion Date: May 2002 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: PendraWatch
    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.
    Other Names:
    • Biostator
    • Somatostatin
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01058577

Locations
Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460
Sponsors and Collaborators
Profil Institut für Stoffwechselforschung GmbH
Pendragon Medical AG Switzerland
Investigators
Principal Investigator: Christoph Kapitza, MD Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
  More Information

No publications provided

Responsible Party: Christoph Kapitza, MD, Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
ClinicalTrials.gov Identifier: NCT01058577     History of Changes
Other Study ID Numbers: B1-2001-01
Study First Received: January 27, 2010
Last Updated: January 27, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Profil Institut für Stoffwechselforschung GmbH:
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014