Diabetes MellitusPhase 1NCT01058577
Changes in Serum Electrolytes at Different Glucose Concentrations + Impact on a Non-invasive Glucose Monitoring Method
A Phase 1 study testing Non-invasive CGMS and Hyperglycemic glucose clamp in people with Diabetes Mellitus, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Non-invasive CGMS and Hyperglycemic glucose clamp
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2001to Aug 2002
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent
- Age between 18 and 65 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Non-invasive CGMS, Hyperglycemic glucose clamp
- Keywords
- diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive CGMSDevice
Also called PendraWatch
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.
Hyperglycemic glucose clampProcedure or surgery
Also called Biostator, Somatostatin
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma ion concentrations (sodium, potassium, chloride, calcium, magnesium) and osmolarity
Measured: 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
Measured: continuously during glucose clamp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startDec 2001
- Primary completionMay 2002
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pendragon Medical AG Switzerland
- Investigators
- Christoph Kapitza, MD, Principal investigator, Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058577
- Sponsor's protocol ID
- B1-2001-01
- Status last verified
- Jan 2010
- First submitted
- 27 Jan 2010
- Last updated
- 28 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01058577
- Acronym / sponsor ID
- B1-2001-01
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Pendragon Medical AG Switzerland
- Study start
- Dec 2001
- Primary completion
- May 2002 (actual)
- Study completion
- Aug 2002 (actual)
- First posted
- 28 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Written informed consent
- Age between 18 and 65 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive CGMSAlso: PendraWatchA 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. | Device | – |
| Hyperglycemic glucose clampAlso: Biostator, SomatostatinThe 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. | Procedure or surgery | – |
Primary outcome
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
1 secondary outcome
blood glucose concentration
Time frame: continuously during glucose clamp
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Kapitza, MD principal investigator
Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Non-invasive CGMS and Hyperglycemic glucose clamp in people with Diabetes Mellitus, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2010.