Diabetes MellitusNCT01324739
B-type Natriuretic Peptide and Glucose Metabolism
A study testing human BNP-32 in people with Diabetes Mellitus and Cardiomyopathy, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Rationale: B type natriuretic peptide (BNP) is a hormone released from cardiomyocytes in response to myocyte stretching and serves as a reliable biomarker in the diagnosis of cardiac dysfunction and heart failure. Recent observations speak for a distinct connection between chronic heart failure and diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Cardiomyopathy
- What is being tested?
- human BNP-32
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- May 2010to Oct 2010
- Phase
- Interventional
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- written informed consent no disease history BNP level within the normal range Normal renal function (serum creatinine of more than 1.3 mg/dL and/or creatinin clearance greater than 80ml/min) Normal ECG
Who cannot join
- systolic blood pressure < 90 mmHg subjects on any medication abnormal glucose metabolism history of anaphylaxis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: B-type Natriuretic Peptide Affects the Initial Response to Intravenous Glucose in a Placebo-controlled Cross-over Study in Healthy Volunteers
Rationale: B type natriuretic peptide (BNP) is a hormone released from cardiomyocytes in response to myocyte stretching and serves as a reliable biomarker in the diagnosis of cardiac dysfunction and heart failure. Recent observations speak for a distinct connection between chronic heart failure and diabetes mellitus.
Objective: The study was set out to investigate the role of BNP on parameters of glucose metabolism in a placebo controlled cross-over study in healthy volunteers.
Read more
Methods and Results: Ten participants (25±1 years; BMI 23±1 kg/m2; fasting glucose 83±2 mg/dL) received either placebo or 3 pmol/kg/min BNP 32 intravenously for 4h. One hour after beginning the BNP/placebo infusion, a 3h intravenous glucose tolerance test (0.33 g/kg glucose + 0.03 U/kg insulin at 20 min) was performed and plasma glucose, insulin and C peptide were frequently measured. BNP increased the initial glucose distribution volume (13±1 %BW vs. 11±1, P<0.002), leading to an overall reduction of glucose concentration (P<0.001) especially during the initial 20 min of the test (P=0.001), accompanied by a reduction of the initial C peptide levels (4.3±0.4 ng/mL vs. 4.9±0.3, P=0.015). BNP had no impact on beta cell function, insulin clearance or insulin sensitivity.
Discussion: Intravenous administration of BNP increases glucose initial distribution volume and lowers plasma glucose concentrations after a glucose load without affecting beta cell function or insulin sensitivity what speaks for the concept that BNP is not diabetogenic, but improves the metabolic status in patients with heart failure. This opens new questions regarding BNP induced differences in glucose availability and signalling in several organs/tissues.
Read the detailed description
In one of our recent studies we investigated insulin sensitivity (OGIS index) and insulin secretion (beta cell function with the insulinogenic index, IGI) in patients with heart insufficiency by frequently sampled oral glucose tolerance test (21). Insulin sensitivity was impaired in CHF compared to control (OGIS: 354±14 ml/min/m2 vs. 450±20; p<0.003). Also beta cell function was reduced (IGI: 100±14 vs. 150±45 pmolINS/pmolGLUC). Interestingly a significant inverse correlation exists between BNP and IGI (r=0.41, p<0.05) (21). The relationship between BNP and glucose metabolism has only been partially investigated. Plasma BNP rises in response to hyperglycemia, but is not influenced by hyperinsulinemia (22, 23). On the other side, the physiological role of BNP on beta cell function and insulin sensitivity has not been investigated to date. As BNP levels rise with the degree of heart insufficiency and insulin resistance correlates to the degree of cardiomyopathy, we hypothesize that BNP influences glucose metabolism in healthy men.
One gold standard investigation of both beta cell function and peripheral insulin sensitivity is the insulin-modified frequently sampled intravenous glucose tolerance test (FSIGT). The FSIGT consists in giving intravenously a glucose bolus at time point 0 followed by an intravenous administration of insulin at time point 20 minutes (18,19, 20). The determination of glucose, insulin and C-peptide at frequent intervals till time point 180 minutes allows the calculation of the acute insulin response, glucose effectiveness, insulin clearance and insulin sensitivity through the minimal model analysis (13) The intravenous administration of 3 pmol/kg/min BNP achieves a plateau of increased BNP plasma concentrations after 60 minutes. In previous publications, this infusion was administered during 4 hours, achieving a steady state plasma BNP between time points 60 minutes and 240 minutes (17). Using this already established protocol, we aim to maintain constantly high plasma BNP levels throughout the three hours of the FSIGT. The combination of both BNP (17) and FSIGT (13) protocols in an interventional study will be an adequate means of investigating the impact of BNP on glucose metabolism in healthy subjects.
The present study aims to investigate the effect of intravenous infusion of BNP-32 (American Peptide, Calif., US) on the beta cell function and insulin sensitivity during FSIGT in healthy volunteers.
-65, -60, -30, 0, 3, 4, 5, 6, 8, 10, 14, 19, 22, 27, 30, 35, 40, 50, 60, 70, 90, 100, 120, 140, 150 and 180 min for the measurement of glucose, insulin and C-peptide (8 ml per time point: time points -30, 0, 3, 4, 5, 6, 8, 10, 14, 19, 22, 27, 30, 35, 40, 50, 70, 100, 140 and 180 min), for the measurement of BNP and NT-proBNP (4 ml per time point: time points -65, -60, -30, 0, 30, 60, 90, 120, 150 and 180 min) and for the measurement of plasma sodium, potassium and creatinine (8 ml per time point: time points -60, 60 and 180 minutes).
Primary outcome parameter is area under the curve of insulin (AUCinsulin) from time point -30 to 180 min.
Secondary outcome parameters are AUCglucose and AUCc-peptide from time point -30 to 180 min, BNP- and NT-proBNP levels from time point -65 to 180, plasma sodium, potassium and creatinine from time point -60 to 180.
On study days volunteers will come to the study room at around 07:45 a.m. after an overnight fasting. After being weighed, they will remain in bed throughout the study, except when standing to pass urine. Two vein flow needles (Venflon, Helsingborg, Sweden) will be inserted in the antecubital veins of the right and left arm for the administration of infusions and blood sampling respectively. The subjects will rest for approximately 15 minutes before obtaining baseline blood samples (at time point - 65 minutes).
3.0 pmol/kg/min human BNP-32 (American Peptide, Calif., US) which is solved in Haemaccel (10 mL/h), or placebo (Haemaccel, 10 mL/h, alone) will be continuously administered for 4 hours, between time points -60 and 180 minutes, using a syringe pump (Treonic, Vickers Medical, Basingstoke, United Kingdom). A washout period of at least 2 weeks will be between the administration of BNP and placebo on the two different study days. This protocol has been used in the study of Lainchbury et al. (17).
330 mg/kg body weight glucose will be administered as a bolus during 30 seconds at time point 0-0.5 minutes.
0.03 IU/kg rapidly acting insulin (Actrapid, Novo-Nordisk, Denmark) will be infused intravenously for 5 minutes starting at time point 20.
Blood samples will be collected at time points: -65, -60, -30, 0, 3, 4, 5, 6, 8, 10, 14, 19, 22, 27, 30, 35, 40, 50, 60, 70, 90, 100, 120, 140, 150 and 180 min for the measurement of glucose, insulin and C-peptide (8 ml per time point: time points -30, 0, 3, 4, 5, 6, 8, 10, 14, 19, 22, 27, 30, 35, 40, 50, 70, 100, 140 and 180 min), for the measurement of BNP and NT-proBNP (4 ml per time point: time points -65, -60, -30, 0, 30, 60, 90, 120, 150 and 180 min) and for the measurement of plasma sodium, potassium and creatinine (8 ml per time point: time points -60, 60 and 180 minutes).
A final safety blood sample will be collected at time point 270 min for plasma sodium, potassium, creatinine and BNP, NT-proBNP, sodium, potassium, creatinine, GPT, gamma-GT, total bilirubin to ensure that (NT-pro)BNP levels returned to baseline and other parameters are within the normal range.
Total volume of blood withdrawal will be about 230 ml. When voiding, the subjects will be asked to collect the urine excreted during the study period (-65 till 180 minutes). for the measurement of sodium, potassium and creatinine excretion.
Heart rate and blood pressure will be continuously monitored during the whole study. If the systolic blood pressure is lower than 85 mmHg or the heart rate is less than 50 beats per minute BNP infusion will be stopped.
Data analysis for estimating insulin sensitivity, ß-cell secretion, insulin clearance, insulin hepatic extraction and insulin appearance rate will be done by minimal model computer analysis of the frequently sampled intravenous glucose tolerance test
- Conditions
- Diabetes Mellitus, Cardiomyopathy
- Being tested
- human BNP-32
- Medical subject headings
- Diabetes Mellitus, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human BNP-32Drug
Also called human b-type natriuretic peptide
3pmol/kg/min infusion
| Study group | Role | What they receive |
|---|---|---|
| B-type natriuretic peptide | Active comparator | the effect of B-type natriuretic peptide on glucose metabolism will be compared with placebo during an intravenous glocose tolerance test Receives: Drug: human BNP-32 |
| Placebo | Placebo comparator | comparison of the effect of b-type natriuretic peptide on glucose metabolism and placebo Receives: Drug: human BNP-32 |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose
Measured: 0 to 180 minutes
Secondary outcomes (1)
insulin, c-peptide
Measured: 0 to 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startMay 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Martin Clodi, Prof., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324739
- Sponsor's protocol ID
- OeNB 13583
- Status last verified
- Oct 2010
- First submitted
- 28 Mar 2011
- Last updated
- 29 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Heinisch BB, Vila G, Resl M, Riedl M, Dieplinger B, Mueller T, Luger A, Pacini G, Clodi M. B-type natriuretic peptide (BNP) affects the initial response to intravenous glucose: a randomised placebo-controlled cross-over study in healthy men. Diabetologia. 2012 May;55(5):1400-5. doi: 10.1007/s00125-011-2392-1. Epub 2011 Dec 13.
PubMed 22159910
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B-type Natriuretic Peptide Affects the Initial Response to Intravenous Glucose in a Placebo-controlled Cross-over Study in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01324739
- Acronym / sponsor ID
- OeNB 13583
- Conditions
- Diabetes Mellitus, Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 29 Mar 2011 (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.
Rationale: B type natriuretic peptide (BNP) is a hormone released from cardiomyocytes in response to myocyte stretching and serves as a reliable biomarker in the diagnosis of cardiac dysfunction and heart failure. Recent observations speak for a distinct connection between chronic heart failure and diabetes mellitus.
Objective: The study was set out to investigate the role of BNP on parameters of glucose metabolism in a placebo controlled cross-over study in healthy volunteers.
Methods and Results: Ten participants (25±1 years; BMI 23±1 kg/m2; fasting glucose 83±2 mg/dL) received either placebo or 3 pmol/kg/min BNP 32 intravenously for 4h. One hour after beginning the BNP/placebo infusion, a 3h intravenous glucose tolerance test (0.33 g/kg glucose + 0.03 U/kg insulin at 20 min) was performed and plasma glucose, insulin and C peptide were frequently measured. BNP increased the initial glucose distribution volume (13±1 %BW vs. 11±1, P<0.002), leading to an overall reduction of glucose concentration (P<0.001) especially during the initial 20 min of the test (P=0.001), accompanied by a reduction of the initial C peptide levels (4.3±0.4 ng/mL vs. 4.9±0.3, P=0.015). BNP had no impact on beta cell function, insulin clearance or insulin sensitivity.
Discussion: Intravenous administration of BNP increases glucose initial distribution volume and lowers plasma glucose concentrations after a glucose load without affecting beta cell function or insulin sensitivity what speaks for the concept that BNP is not diabetogenic, but improves the metabolic status in patients with heart failure. This opens new questions regarding BNP induced differences in glucose availability and signalling in several organs/tissues.
Detailed description
In one of our recent studies we investigated insulin sensitivity (OGIS index) and insulin secretion (beta cell function with the insulinogenic index, IGI) in patients with heart insufficiency by frequently sampled oral glucose tolerance test (21). Insulin sensitivity was impaired in CHF compared to control (OGIS: 354±14 ml/min/m2 vs. 450±20; p<0.003). Also beta cell function was reduced (IGI: 100±14 vs. 150±45 pmolINS/pmolGLUC). Interestingly a significant inverse correlation exists between BNP and IGI (r=0.41, p<0.05) (21). The relationship between BNP and glucose metabolism has only been partially investigated. Plasma BNP rises in response to hyperglycemia, but is not influenced by hyperinsulinemia (22, 23). On the other side, the physiological role of BNP on beta cell function and insulin sensitivity has not been investigated to date. As BNP levels rise with the degree of heart insufficiency and insulin resistance correlates to the degree of cardiomyopathy, we hypothesize that BNP influences glucose metabolism in healthy men.
One gold standard investigation of both beta cell function and peripheral insulin sensitivity is the insulin-modified frequently sampled intravenous glucose tolerance test (FSIGT). The FSIGT consists in giving intravenously a glucose bolus at time point 0 followed by an intravenous administration of insulin at time point 20 minutes (18,19, 20). The determination of glucose, insulin and C-peptide at frequent intervals till time point 180 minutes allows the calculation of the acute insulin response, glucose effectiveness, insulin clearance and insulin sensitivity through the minimal model analysis (13) The intravenous administration of 3 pmol/kg/min BNP achieves a plateau of increased BNP plasma concentrations after 60 minutes. In previous publications, this infusion was administered during 4 hours, achieving a steady state plasma BNP between time points 60 minutes and 240 minutes (17). Using this already established protocol, we aim to maintain constantly high plasma BNP levels throughout the three hours of the FSIGT. The combination of both BNP (17) and FSIGT (13) protocols in an interventional study will be an adequate means of investigating the impact of BNP on glucose metabolism in healthy subjects.
The present study aims to investigate the effect of intravenous infusion of BNP-32 (American Peptide, Calif., US) on the beta cell function and insulin sensitivity during FSIGT in healthy volunteers.
-65, -60, -30, 0, 3, 4, 5, 6, 8, 10, 14, 19, 22, 27, 30, 35, 40, 50, 60, 70, 90, 100, 120, 140, 150 and 180 min for the measurement of glucose, insulin and C-peptide (8 ml per time point: time points -30, 0, 3, 4, 5, 6, 8, 10, 14, 19, 22, 27, 30, 35, 40, 50, 70, 100, 140 and 180 min), for the measurement of BNP and NT-proBNP (4 ml per time point: time points -65, -60, -30, 0, 30, 60, 90, 120, 150 and 180 min) and for the measurement of plasma sodium, potassium and creatinine (8 ml per time point: time points -60, 60 and 180 minutes).
Primary outcome parameter is area under the curve of insulin (AUCinsulin) from time point -30 to 180 min.
Secondary outcome parameters are AUCglucose and AUCc-peptide from time point -30 to 180 min, BNP- and NT-proBNP levels from time point -65 to 180, plasma sodium, potassium and creatinine from time point -60 to 180.
On study days volunteers will come to the study room at around 07:45 a.m. after an overnight fasting. After being weighed, they will remain in bed throughout the study, except when standing to pass urine. Two vein flow needles (Venflon, Helsingborg, Sweden) will be inserted in the antecubital veins of the right and left arm for the administration of infusions and blood sampling respectively. The subjects will rest for approximately 15 minutes before obtaining baseline blood samples (at time point - 65 minutes).
3.0 pmol/kg/min human BNP-32 (American Peptide, Calif., US) which is solved in Haemaccel (10 mL/h), or placebo (Haemaccel, 10 mL/h, alone) will be continuously administered for 4 hours, between time points -60 and 180 minutes, using a syringe pump (Treonic, Vickers Medical, Basingstoke, United Kingdom). A washout period of at least 2 weeks will be between the administration of BNP and placebo on the two different study days. This protocol has been used in the study of Lainchbury et al. (17).
330 mg/kg body weight glucose will be administered as a bolus during 30 seconds at time point 0-0.5 minutes.
0.03 IU/kg rapidly acting insulin (Actrapid, Novo-Nordisk, Denmark) will be infused intravenously for 5 minutes starting at time point 20.
Blood samples will be collected at time points: -65, -60, -30, 0, 3, 4, 5, 6, 8, 10, 14, 19, 22, 27, 30, 35, 40, 50, 60, 70, 90, 100, 120, 140, 150 and 180 min for the measurement of glucose, insulin and C-peptide (8 ml per time point: time points -30, 0, 3, 4, 5, 6, 8, 10, 14, 19, 22, 27, 30, 35, 40, 50, 70, 100, 140 and 180 min), for the measurement of BNP and NT-proBNP (4 ml per time point: time points -65, -60, -30, 0, 30, 60, 90, 120, 150 and 180 min) and for the measurement of plasma sodium, potassium and creatinine (8 ml per time point: time points -60, 60 and 180 minutes).
A final safety blood sample will be collected at time point 270 min for plasma sodium, potassium, creatinine and BNP, NT-proBNP, sodium, potassium, creatinine, GPT, gamma-GT, total bilirubin to ensure that (NT-pro)BNP levels returned to baseline and other parameters are within the normal range.
Total volume of blood withdrawal will be about 230 ml. When voiding, the subjects will be asked to collect the urine excreted during the study period (-65 till 180 minutes). for the measurement of sodium, potassium and creatinine excretion.
Heart rate and blood pressure will be continuously monitored during the whole study. If the systolic blood pressure is lower than 85 mmHg or the heart rate is less than 50 beats per minute BNP infusion will be stopped.
Data analysis for estimating insulin sensitivity, ß-cell secretion, insulin clearance, insulin hepatic extraction and insulin appearance rate will be done by minimal model computer analysis of the frequently sampled intravenous glucose tolerance test
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B-type natriuretic peptide | Active comparator | Drug: human BNP-32the effect of B-type natriuretic peptide on glucose metabolism will be compared with placebo during an intravenous glocose tolerance test |
| Placebo | Placebo comparator | Drug: human BNP-32comparison of the effect of b-type natriuretic peptide on glucose metabolism and placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- written informed consent no disease history BNP level within the normal range Normal renal function (serum creatinine of more than 1.3 mg/dL and/or creatinin clearance greater than 80ml/min) Normal ECG
Key exclusion criteria (1 listed)
- systolic blood pressure < 90 mmHg subjects on any medication abnormal glucose metabolism history of anaphylaxis
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 |
|---|---|---|
| human BNP-32Also: human b-type natriuretic peptide3pmol/kg/min infusion | Drug | B-type natriuretic peptide, Placebo |
Primary outcome
glucose
Time frame: 0 to 180 minutes
1 secondary outcome
insulin, c-peptide
Time frame: 0 to 180 minutes
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 29 Mar 2011.
- Derived from this study: PubMed 22159910Heinisch BB, Vila G, Resl M, Riedl M, Dieplinger B, Mueller T, Luger A, Pacini G, Clodi M. B-type natriuretic peptide (BNP) affects the initial response to intravenous glucose: a randomised placebo-controlled cross-over study in healthy men. Diabetologia. 2012 May;55(5):1400-5. doi: 10.1007/s00125-011-2392-1. Epub 2011 Dec 13.
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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.
Martin Clodi, Prof. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing human BNP-32 in people with Diabetes Mellitus and Cardiomyopathy, run by Medical University of Vienna at 1 site in Austria.
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 1 inclusion and 1 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 29 Mar 2011. 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 Austria. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
glucose (time frame: 0 to 180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01324739, which also lists 1 linked publication.
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 29 Mar 2011.