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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020114-29 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No treatment | No Intervention | ||
| Glukose-infusion | Active Comparator | Glucose-infusion during hemodialysis |
|
| Glucose-insulin infusion | Active Comparator | Glucose-insulin infusion during hemodialysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucose-infusion | Drug | Continuous iv infusion of glucose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From 2 h prior to start of hemodialysis to 2 h after end of hemodialysis |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship between inflammatory markers and plasma concentrations of IGF-I and IGFBP-1 during hemodialysis | From 2 h prior to start of hemodialysis to 2 h after end of hemodialysis |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria during the study:
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| Name | Affiliation | Role |
|---|---|---|
| Per Ivarsen, MD, PhD | Department of Nephrology, Aarhus University Hospital, Skejby | Study Director |
| Jan Frystyk, MD,PhD,DMSc | Department of Endocrinology and Internal Medicine, Aarhus University Hospital | Study Director |
| Bente Jespersen, MD, DMSc | Department of Nephrology, Aarhus University Hospital, Skejby | Study Director |
| Mark Reinhard, MD | Department of Nephrology, Aarhus University Hospital, Skejby | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nephrology, Aarhus University Hospital, Skejby | Aarhus | 8200 N | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23557110 | Derived | 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. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D044342 | Malnutrition |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Glucose-insulin infusion | Drug | Continuous iv infusion of glucose and shortlasting |
|
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |