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

NCT01058577 | Completed Phase 1

• 1 other identifier: B1-2001-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Diabetes Mellitus

Keywords

diabetes

Outcome Measures

Primary Outcomes (1)

• plasma ion concentrations (sodium, potassium, chloride, calcium, magnesium) and osmolarity

  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

  continuously during glucose clamp

Interventions

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.

Also known as: 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.

Also known as: Biostator, Somatostatin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Age between 18 and 65 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Profil Institut für Stoffwechselforschung GmbH: lead
• Pendragon Medical AG Switzerland: collaborator

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Somatostatin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Christoph Kapitza, MD

  Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 27, 2010
• First Posted: January 28, 2010
• Study Start: December 1, 2001
• Primary Completion: May 1, 2002
• Study Completion: August 1, 2002
• Last Updated: January 28, 2010

Record last verified: 2010-01

Locations

DE (1)