Kidney Failure, ChronicPhase 4NCT01209403
Insulin-like Growth Factor (IGF-I) in Hemodialysis Patients
A Phase 4 study testing Glucose-infusion and Glucose-insulin infusion in people with Kidney Failure, Chronic, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate whether the anabolic potentials of insulin may be used to reverse the catabolic effects of hemodialysis in non-diabetic patients with end-stage renal failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Glucose-infusion and Glucose-insulin infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2010to Jul 2011
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years
- stable patients on maintenance hemodialysis for > 3 months
- well-functioning arteriovenous (AV) shunt with recirculation < 5%
- informed consent
Who cannot join
- diabetes mellitus
- body mass index < 18.5 kg/m2 or > 30 kg/m2
- malnutrition (subjective global assessment (SGA) score C)
- malignancy
- use of immunosuppressive drugs including glucocorticosteroids
- severe infectious disease < 4 weeks
Show all 11Show fewer
- pregnancy
- myocardial infarction or arrythmia with hemodynamic derangements
- permanent thrombosis in the arteriovenous (AV) shunt
- severe infectious disease
- renal transplantation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nephrology, Aarhus University Hospital, Skejby
Aarhus, 8200 N
About this study
The purpose of this study is to investigate whether the anabolic potentials of insulin may be used to reverse the catabolic effects of hemodialysis in non-diabetic patients with end-stage renal failure.
Read the detailed description
Nutritional markers such as lean body mass and serum albumin are strong predictors of the mortality and morbidity in patients with end-stage renal failure (ESRF) on maintenance hemodialysis (HD). Maintenance HD is considered to contribute to the malnutrition of patients with ESRF, but the exact mechanism has remained unknown. However, we have recently shown that the bioactivity of insulin-like growth factor-I (IGF-I) is reduced by 50% during HD. Furthermore, we showed that the reduction in the bioactivity of IGF-I is directly linked to an up-regulation of IGF-binding protein-1 (IGFBP-1), the only acutely regulated IGFBP, which increased by 6-fold during HD. IGFBP-1 is produced in the liver, primarily under the control of insulin, which promptly inhibits the hepatic production of IGFBP-1. As plasma insulin remains fairly low during a maintenance HD, the increase in IGFBP-1 may be explained by the absence of insulin.
The finding that HD acutely down-regulates the bioactivity of IGF-I by an up-regulation of IGFBP-1 may not only explain the catabolic mechanisms of HD per se, it also opens for a new treatment strategy of ESRF patients undergoing maintenance HD. Thus, on the basis of our previous study we hypothesize that treatment of ERSF patients with high doses of insulin during maintenance HD may counter-act the HD-induced stimulation of IGFBP-1, making it possible to preserve the bioactivity of IGF-I, and thereby abolishing the catabolic impact of HD.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Glucose-infusion, Glucose-insulin infusion
- Keywords
- Dialysis, Malnutrition, Insulin-Like Growth Factor I, Insulin-Like Growth Factor Binding Protein 1, Inflammation
- Medical subject headings
- Kidney Failure, Chronic, Malnutrition, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose-infusionDrug
Also called Glukose
Continuous iv infusion of glucose
Glucose-insulin infusionDrug
Also called Glukose, Novorapid
Continuous iv infusion of glucose and shortlasting
| Study group | Role | What they receive |
|---|---|---|
| No treatment | No intervention | Not described |
| Glukose-infusion | Active comparator | Glucose-infusion during hemodialysis Receives: Drug: Glucose-infusion |
| Glucose-insulin infusion | Active comparator | Glucose-insulin infusion during hemodialysis Receives: Drug: Glucose-insulin infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of glucose and glucose-insulin infusion on plasma IGF-I and IGFBP-1 during hemodialysis
All patients are randomly assigned to a hemodialysis session with either i) no infusion, ii) a continuous iv infusion of glucose, and iii) a continuous iv infusion of glucose and shortacting insulin. Each dialysis session will be separated by 2 weeks of wash-out
Measured: From 2 h prior to start of hemodialysis to 2 h after end of hemodialysis
Secondary outcomes (1)
Relationship between inflammatory markers and plasma concentrations of IGF-I and IGFBP-1 during hemodialysis
Measured: From 2 h prior to start of hemodialysis to 2 h after end of hemodialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2011
- Study completionJul 2011
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 Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Per Ivarsen, MD, PhD, Study director, Department of Nephrology, Aarhus University Hospital, SkejbyJan Frystyk, MD,PhD,DMSc, Study director, Department of Endocrinology and Internal Medicine, Aarhus University HospitalBente Jespersen, MD, DMSc, Study director, Department of Nephrology, Aarhus University Hospital, SkejbyMark Reinhard, MD, Principal investigator, Department of Nephrology, Aarhus University Hospital, Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209403
- Sponsor's protocol ID
- IGFHD1-2010
- Other IDs
- 2010-020114-29
- Status last verified
- Sep 2011
- First submitted
- 17 Sep 2010
- Last updated
- 30 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Reinhard M, Frystyk J, Jespersen B, Bjerre M, Christiansen JS, Flyvbjerg A, Ivarsen P. Effect of hyperinsulinemia during hemodialysis on the insulin-like growth factor system and inflammatory biomarkers: a randomized open-label crossover study. BMC Nephrol. 2013 Apr 4;14:80. doi: 10.1186/1471-2369-14-80.
PubMed 23557110
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin-like Growth Factor (IGF-I) in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01209403
- Acronym / sponsor ID
- IGFHD1-2010
- Conditions
- Kidney Failure, Chronic
- Keywords
- Dialysis, Malnutrition, Insulin-Like Growth Factor I, Insulin-Like Growth Factor Binding Protein 1, Inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 27 Sep 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.
The purpose of this study is to investigate whether the anabolic potentials of insulin may be used to reverse the catabolic effects of hemodialysis in non-diabetic patients with end-stage renal failure.
Detailed description
Nutritional markers such as lean body mass and serum albumin are strong predictors of the mortality and morbidity in patients with end-stage renal failure (ESRF) on maintenance hemodialysis (HD). Maintenance HD is considered to contribute to the malnutrition of patients with ESRF, but the exact mechanism has remained unknown. However, we have recently shown that the bioactivity of insulin-like growth factor-I (IGF-I) is reduced by 50% during HD. Furthermore, we showed that the reduction in the bioactivity of IGF-I is directly linked to an up-regulation of IGF-binding protein-1 (IGFBP-1), the only acutely regulated IGFBP, which increased by 6-fold during HD. IGFBP-1 is produced in the liver, primarily under the control of insulin, which promptly inhibits the hepatic production of IGFBP-1. As plasma insulin remains fairly low during a maintenance HD, the increase in IGFBP-1 may be explained by the absence of insulin.
The finding that HD acutely down-regulates the bioactivity of IGF-I by an up-regulation of IGFBP-1 may not only explain the catabolic mechanisms of HD per se, it also opens for a new treatment strategy of ESRF patients undergoing maintenance HD. Thus, on the basis of our previous study we hypothesize that treatment of ERSF patients with high doses of insulin during maintenance HD may counter-act the HD-induced stimulation of IGFBP-1, making it possible to preserve the bioactivity of IGF-I, and thereby abolishing the catabolic impact of HD.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No treatment | No intervention | – |
| Glukose-infusion | Active comparator | Drug: Glucose-infusionGlucose-infusion during hemodialysis |
| Glucose-insulin infusion | Active comparator | Drug: Glucose-insulin infusionGlucose-insulin infusion during hemodialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 18 years
- stable patients on maintenance hemodialysis for > 3 months
- well-functioning arteriovenous (AV) shunt with recirculation < 5%
- informed consent
Key exclusion criteria (11 listed)
- diabetes mellitus
- body mass index < 18.5 kg/m2 or > 30 kg/m2
- malnutrition (subjective global assessment (SGA) score C)
- malignancy
- use of immunosuppressive drugs including glucocorticosteroids
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 |
|---|---|---|
| Glucose-infusionAlso: GlukoseContinuous iv infusion of glucose | Drug | Glukose-infusion |
| Glucose-insulin infusionAlso: Glukose, NovorapidContinuous iv infusion of glucose and shortlasting | Drug | Glucose-insulin infusion |
Primary outcome
Effect of glucose and glucose-insulin infusion on plasma IGF-I and IGFBP-1 during hemodialysis
Time frame: From 2 h prior to start of hemodialysis to 2 h after end of hemodialysis
All patients are randomly assigned to a hemodialysis session with either i) no infusion, ii) a continuous iv infusion of glucose, and iii) a continuous iv infusion of glucose and shortacting insulin. Each dialysis session will be separated by 2 weeks of wash-out
1 secondary outcome
Relationship between inflammatory markers and plasma concentrations of IGF-I and IGFBP-1 during hemodialysis
Time frame: From 2 h prior to start of hemodialysis to 2 h after end of hemodialysis
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 30 Sep 2011.
- Derived from this study: PubMed 23557110Reinhard M, Frystyk J, Jespersen B, Bjerre M, Christiansen JS, Flyvbjerg A, Ivarsen P. Effect of hyperinsulinemia during hemodialysis on the insulin-like growth factor system and inflammatory biomarkers: a randomized open-label crossover study. BMC Nephrol. 2013 Apr 4;14:80. doi: 10.1186/1471-2369-14-80.
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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.
Per Ivarsen, MD, PhD study director
Department of Nephrology, Aarhus University Hospital, Skejby
Jan Frystyk, MD,PhD,DMSc study director
Department of Endocrinology and Internal Medicine, Aarhus University Hospital
Bente Jespersen, MD, DMSc study director
Department of Nephrology, Aarhus University Hospital, Skejby
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glucose-infusion and Glucose-insulin infusion in people with Kidney Failure, Chronic, run by University of Aarhus at 1 site in Denmark.
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 4 inclusion and 11 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 30 Sep 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 Denmark. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Effect of glucose and glucose-insulin infusion on plasma IGF-I and IGFBP-1 during hemodialysis (time frame: From 2 h prior to start of hemodialysis to 2 h after end of hemodialysis). 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 NCT01209403, 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 30 Sep 2011.