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Sponsored by: |
Medical Center Alkmaar |
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Information provided by: | Medical Center Alkmaar |
ClinicalTrials.gov Identifier: | NCT00497978 |
The purpose of this study is to reduce the postoperative morbidity and mortality in the elderly hip fracture patient, by giving them taurine peri-operatively.
Condition | Intervention |
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Insulin Resistance Elderly Patient Oxidative Stress |
Drug: taurine |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | The Effect of Taurine on Morbidity and Mortality in the Elderly Hip Fracture Patient |
Estimated Enrollment: | 236 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | July 2010 |
Rationale: A growing medical concern is the increase in the number of very old patients, especially the patients undergoing hip fracture surgery are rapidly increasing in numbers. Hip surgery in these old patients induces serious morbidity and gives rise to excessive mortality rates. Studies with perioperative nutritional interventions performed within this population have shown improved clinical outcome, but were not well controlled and lack insight in the working mechanism. Therefore nutritional intervention studies are needed using a single nutrient. In trauma patients for instance it is known that the administration of glutamine (as a single amino acid) reduces morbidity, which is probably related to its antioxidant properties; reducing oxidative stress and insulin resistance. As an antioxidant the amino acid taurine has even greater potential providing benefit in several groups of patients. Elderly hip fracture patients have very low plasma levels of antioxidants which make them highly vulnerable for oxidative stress and related insulin resistance.In elderly patients with a hip fracture, it is hypothesized that taurine lowers oxidative stress and the related harmful insulin resistance, thereby reducing morbidity and mortality.
Objective: Our primary objective is to reduce morbidity and consequent mortality in the elderly hip fracture patient by the administration of taurine.
Study design: A double blind placebo controlled intervention study at the surgery department of the Medical Center Alkmaar. The study consists of three parts: 1. A dose finding study; 2. Main study: outcome study on morbidity and mortality; 3. A study on insulin resistance, parallel to the main study.
Study population: Patients of both genders and any ethnicity, who will undergo primary surgery for a hip fracture, aged over 75 years, will be eligible for the study.
Intervention: Patients will receive from the moment of admission oral administration of taurine (3g/day or 6g/day, depending on results of the dose finding study) or placebo.
Main study parameters/endpoints: The main study parameter is the morbidity and consequent mortality. The secondary study parameters are oxidative stress, postoperative insulin resistance, mitochondrial dysfunction in skeletal muscle and postoperative delirium.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The possible benefit of the study is related to the effect of taurine. Oral administration of taurine, as an antioxidant, perioperatively, can reduce morbidity and consequent mortality, reduce oxidative stress, counteract the postoperative insulin resistance and thereby enhance the clinical outcome of the elderly hip fracture patient. Research showed that taurine can be safely administered to humans and no adverse effects are reported. A part of the patients will undergo a hyperinsulinaemic euglycaemic clamp to assess hepatic and peripheral insulin sensitivity.
Ages Eligible for Study: | 75 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alexander PJ Houdijk, MD, PhD | 0031 72 5484444 ext 5383 | a.p.j.houdijk@mca.nl |
Netherlands, Noord-Holland | |
Medical Center Alkmaar | Recruiting |
Alkmaar, Noord-Holland, Netherlands, 1800 AM | |
Contact: Alexander PJ Houdijk, MD, PhD 0031 72 5484444 ext 5383 a.p.j.houdijk@mca.nl | |
Principal Investigator: Alexander PJ Houdijk, MD, PhD | |
Sub-Investigator: Mireille FM van Stijn, MD |
Principal Investigator: | Alexander PJ Houdijk, MD, PhD | Medical Center Alkmaar |
Study ID Numbers: | TAUP03.04.07/2 |
Study First Received: | July 6, 2007 |
Last Updated: | July 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00497978 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Hyperinsulinism Hip Fractures Femoral Fractures Metabolic Diseases Fractures, Bone Wounds and Injuries |
Disorders of Environmental Origin Stress Leg Injuries Insulin Resistance Glucose Metabolism Disorders Metabolic Disorder |
Hyperinsulinism Hip Fractures Femoral Fractures Metabolic Diseases Fractures, Bone Wounds and Injuries |
Disorders of Environmental Origin Leg Injuries Hip Injuries Insulin Resistance Glucose Metabolism Disorders |