The Effect of Taurine on Morbidity and Mortality in the Elderly Hip Fracture Patient

Insulin Resistance Clinical Trial

— TAUP  

Official title:

The Effect of Taurine on Morbidity and Mortality in the Elderly Hip Fracture Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497978
• Other study ID #: TAUP03.04.07/2
• Status: Completed
• Phase: N/A
• First received: July 6, 2007
• Last updated: December 27, 2011
• Start date: March 2008
• Est. completion date: October 2011

Study information

• Verified date: December 2011
• Source: Medical Center Alkmaar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• age above 75 years old

• hip fracture with a primary indication for surgery

• having obtained his/her informed consent

Exclusion Criteria:

• participating in another clinical trial

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Elderly Patient
• Hip Fractures
• Insulin Resistance
• Oxidative Stress

Intervention

Dietary Supplement:
• taurine
6 grams of taurine will be given each day in capsules, starting the day of admission till the sixth postoperative day
• placebo
a similar amount of placebo will be given each day in capsules, starting the day of admission till the sixth postoperative day

Locations

Country	Name	City	State
Netherlands	Medical Center Alkmaar	Alkmaar	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Medical Center Alkmaar

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morbidity and mortality		1 year	No
Secondary	antioxidant/oxidant parameters and inflammatory mediators		1 week	No
Secondary	postoperative insulin resistance		1 week	No
Secondary	mitochondrial dysfunction in the skeletal muscle		1 week	No
Secondary	postoperative delirium incidence, duration and severity		1 week	No