<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03277014</url>
  </required_header>
  <id_info>
    <org_study_id>201502022-3</org_study_id>
    <nct_id>NCT03277014</nct_id>
  </id_info>
  <brief_title>Using IGF-1 for Nutritional Monitoring</brief_title>
  <official_title>Insulin-like Growth Factor-1 as a Nutritional Monitoring Factor in Patients With Chronic Intestinal Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wang Xinying</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jinling Hospital, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nutrition support is critical to a vast number of patients who are hospitalized annually&#xD;
      because of critical illnesses or surgery. It is also necessary for patients with chronic&#xD;
      intestinal failure (CIF), who often require parenteral nutrition over periods of weeks or&#xD;
      months. While scoring systems that assess nutritional risks in patients exist, there are no&#xD;
      guidelines for continuous nutritional monitoring during supplementation and parenteral&#xD;
      feeding. Previous studies have hinted that insulin-like growth factor-1 (IGF-1) may serve as&#xD;
      a biomarker for nutritional support efficiency; however, such studies were not statistically&#xD;
      definitive. Therefore, the investigators aimed to assess IGF-1 as a biomarker for both&#xD;
      diagnosing nutritional risk and malnutrition and for monitoring the efficiency of nutritional&#xD;
      support, particularly compared to other biomarkers such as BMI as well as albumin,&#xD;
      prealbumin, transferrin, and retinol-binding protein.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic intestinal failure (CIF) is one of the rarest of organ failures all over the world,&#xD;
      mainly caused by severe gastrointestinal or systemic benign diseases such as intestinal&#xD;
      ﬁstula, short bowel, and mechanical obstruction. Moreover, patients with end-stage&#xD;
      intra-abdominal or pelvic cancer can also develop into CIF. CIF is deﬁned as gut function&#xD;
      that is below the minimum necessary for the absorption of macronutrients and/or water and&#xD;
      electrolytes; in such cases, nutrition support, especially for parenteral nutrition, is&#xD;
      indispensable to maintain health and recovery for CIF patients.&#xD;
&#xD;
      Nutrition support has successfully saved the lives of thousands of patients with CIF, as well&#xD;
      as those who have critical illnesses or underwent surgery. According to the guidelines,&#xD;
      patients with CIF require parenteral nutrition over periods of weeks or months and the&#xD;
      efficiency of nutrition support will influence the prognoses directly . The exact nutritional&#xD;
      assessment and close nutritional monitoring are key points to optimize nutritional therapy.&#xD;
      Firstly, the recommended scoring systems such as the Nutritional Risk Screening 2002&#xD;
      (NRS-2002) score or the 'nutrition risk in the critically ill' (NUTRIC) score can identify&#xD;
      patients who are at nutritional risk and who would benefit from nutritional support.&#xD;
      Secondly, nutritional support regimens should be individualized and adjusted over time based&#xD;
      on continuous monitoring; however, there are no guidelines regarding such nutritional&#xD;
      monitoring. The NRS-2002 and NUTRIC scores are recommended as initial nutritional assessment&#xD;
      indices, but are inappropriate for continuous evaluation. Moreover, validated biomarkers that&#xD;
      can be used for monitoring short-term nutritional status changes were still unclear.&#xD;
      Nowadays, common serum protein markers such like albumin, prealbumin, transferrin, and&#xD;
      retinol-binding protein (RBP) are used to monitor the efficiency of nutritional support in&#xD;
      clinical practice [5, 8]. However, all these biomarkers failed to reflect changes of&#xD;
      nutritional status with sufficient sensitivity in CIF patients.&#xD;
&#xD;
      Insulin-like growth factor-1 (IGF-1) is an IGF family member that consists of 70 amino acid&#xD;
      residues. IGF-I was first reported as a nutritional marker in 1973 because its serum&#xD;
      concentrations are reduced during malnutrition; its serum levels also proved to be affected&#xD;
      by protein or/and energy deficiency. Several previous studies reported that IGF-1 is a more&#xD;
      sensitive and speciﬁc indicator of nutritional status than prealbumin, transferrin, or RBP&#xD;
      because of its shorter serum half-life and more accurate response to nutritional intake;&#xD;
      however, these studies had small cohorts.&#xD;
&#xD;
      In present study, the investigators compared IGF-1 to traditional serum biomarkers in terms&#xD;
      of diagnosing nutritional risk and malnutrition, as well as in monitoring the efficiency of&#xD;
      nutrition support in CIF patients.&#xD;
&#xD;
      the investigators conducted a retrospective study of patients treated at a single clinical&#xD;
      nutrition center of a tertiary referral hospital in China to investigate whether the&#xD;
      measurement of IGF-1 is useful for monitoring the efficiency of nutritional support and to&#xD;
      explore the relationship between IGF-1 and lean body mass in CIF patients. The influence of&#xD;
      IGF-1 was also explored in this study. The data used were accumulated at the center between&#xD;
      September 2013 and January 2017. All adult CIF patients (age ≥18 years) receiving nutrition&#xD;
      support were included. The exclusion criteria were hepatic insufficiency (alanine&#xD;
      transaminase/aspartate transaminase ratio 200% above normal range or bilirubin &gt;3 mg/dL),&#xD;
      renal insufficiency (serum creatinine [Scr] &gt;1.5 mg/dL), acute or life-threatening diseases&#xD;
      (e.g., shock, collapse, stroke, coma of unknown etiology, or recent cardiac infarction), and&#xD;
      pregnant or breast-feeding women. The study was approved by the ethics committee of Jinling&#xD;
      Hospital, Medical School of Nanjing University.&#xD;
&#xD;
      Malnutrition was defined as weight loss &gt;10% within 6 months, a body mass index (BMI) &lt;18.5,&#xD;
      a subjective global assessment (SGA) score of stage C, or albumin level &lt;30 g/L. Serum IGF-1,&#xD;
      albumin, pre-albumin, transferrin, RBP, creatinine, and hemoglobin were measured weekly in&#xD;
      patients receiving nutrition support after hospital admission. The resting energy&#xD;
      expenditure, predicted weekly by indirect calorimetry (Quark PFT ERGO , COSMED Srl - Italy),&#xD;
      was used to guide energy delivery. The target dose of protein intake was 1.2 g/kg/day, which&#xD;
      was adjusted according to the level of serum albumin. Patients were also subjected to strict&#xD;
      fluid intake management. The nutritional support schemes were recorded daily, and the body&#xD;
      composition was also measured weekly to estimate nutrition status (Inbody S10, Biospace).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2013</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Nutrition indicators</measure>
    <time_frame>From date of patients enrollment until the date of patients discharge from hospital, assessed up to 2 months.</time_frame>
    <description>Insulin-like growth factor-1/Hemoglobin/albumin/prealbumin/transferrin/retinol binding protein/serum creatinine/cholesterol</description>
  </primary_outcome>
  <enrollment type="Actual">197</enrollment>
  <condition>Nutritional Supplement</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated at a single clinical nutrition center of a tertiary referral hospital in&#xD;
        China to investigate whether the measurement of IGF-1 is useful for monitoring the&#xD;
        efficiency of nutritional support and to explore the relationship between IGF-1 and lean&#xD;
        body mass in CIF patients. The data used were accumulated at the center between September&#xD;
        2013 and January 2017.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult CIF patients (age ≥18 years) receiving nutrition support were included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hepatic insufficiency (alanine transaminase/aspartate transaminase ratio 200% above&#xD;
             normal range or bilirubin &gt;3 mg/dL), renal insufficiency (serum creatinine [Scr] &gt;1.5&#xD;
             mg/dL), acute or life-threatening diseases (e.g., shock, collapse, stroke, coma of&#xD;
             unknown etiology, or recent cardiac infarction), and pregnant or breast-feeding women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>1. Bielawska B, Allard JP. Nutrients 2017, 9(5). 2. Pironi L, Arends J, Bozzetti F, Cuerda C, Gillanders L, Jeppesen PB, Joly F, Kelly D, Lal S, Staun M et al. Clinical nutrition 2016, 35(2):247-307. 3. Pironi L. Best Pract Res Clin Gastroenterol 2016, 30(2):173-185. 4. Feinberg J, Nielsen EE, Korang SK, Halberg Engell K, Nielsen MS, Zhang K, Didriksen M, Lund L, Lindahl N, Hallum S et al. The Cochrane database of systematic reviews 2017, 5:Cd011598. 5. Taylor BE, McClave SA, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA et al. Crit Care Med 2016, 44(2):390-438. 6. McClave SA, DiBaise JK, Mullin GE, Martindale RG. Am J Gastroenterol 2016, 111(3):315-334.</citation>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 3, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Jinling Hospital, China</investigator_affiliation>
    <investigator_full_name>Wang Xinying</investigator_full_name>
    <investigator_title>Director of the clinical nutrition center</investigator_title>
  </responsible_party>
  <keyword>Nutritional monitoring</keyword>
  <keyword>insulin-like growth factor-1</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03277014
org study id: 201502022-3
nct id: NCT03277014
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Nutrition support is critical to a vast number of patients who are hospitalized annually
      because of critical illnesses or surgery. It is also necessary for patients with chronic
      intestinal failure (CIF), who often require parenteral nutrition over periods of weeks or
      months. While scoring systems that assess nutritional risks in patients exist, there are no
      guidelines for continuous nutritional monitoring during supplementation and parenteral
      feeding. Previous studies have hinted that insulin-like growth factor-1 (IGF-1) may serve as
      a biomarker for nutritional support efficiency; however, such studies were not statistically
      definitive. Therefore, the investigators aimed to assess IGF-1 as a biomarker for both
      diagnosing nutritional risk and malnutrition and for monitoring the efficiency of nutritional
      support, particularly compared to other biomarkers such as BMI as well as albumin,
      prealbumin, transferrin, and retinol-binding protein.
Chronic intestinal failure (CIF) is one of the rarest of organ failures all over the world,
      mainly caused by severe gastrointestinal or systemic benign diseases such as intestinal
      ﬁstula, short bowel, and mechanical obstruction. Moreover, patients with end-stage
      intra-abdominal or pelvic cancer can also develop into CIF. CIF is deﬁned as gut function
      that is below the minimum necessary for the absorption of macronutrients and/or water and
      electrolytes; in such cases, nutrition support, especially for parenteral nutrition, is
      indispensable to maintain health and recovery for CIF patients.

      Nutrition support has successfully saved the lives of thousands of patients with CIF, as well
      as those who have critical illnesses or underwent surgery. According to the guidelines,
      patients with CIF require parenteral nutrition over periods of weeks or months and the
      efficiency of nutrition support will influence the prognoses directly . The exact nutritional
      assessment and close nutritional monitoring are key points to optimize nutritional therapy.
      Firstly, the recommended scoring systems such as the Nutritional Risk Screening 2002
      (NRS-2002) score or the 'nutrition risk in the critically ill' (NUTRIC) score can identify
      patients who are at nutritional risk and who would benefit from nutritional support.
      Secondly, nutritional support regimens should be individualized and adjusted over time based
      on continuous monitoring; however, there are no guidelines regarding such nutritional
      monitoring. The NRS-2002 and NUTRIC scores are recommended as initial nutritional assessment
      indices, but are inappropriate for continuous evaluation. Moreover, validated biomarkers that
      can be used for monitoring short-term nutritional status changes were still unclear.
      Nowadays, common serum protein markers such like albumin, prealbumin, transferrin, and
      retinol-binding protein (RBP) are used to monitor the efficiency of nutritional support in
      clinical practice [5, 8]. However, all these biomarkers failed to reflect changes of
      nutritional status with sufficient sensitivity in CIF patients.

      Insulin-like growth factor-1 (IGF-1) is an IGF family member that consists of 70 amino acid
      residues. IGF-I was first reported as a nutritional marker in 1973 because its serum
      concentrations are reduced during malnutrition; its serum levels also proved to be affected
      by protein or/and energy deficiency. Several previous studies reported that IGF-1 is a more
      sensitive and speciﬁc indicator of nutritional status than prealbumin, transferrin, or RBP
      because of its shorter serum half-life and more accurate response to nutritional intake;
      however, these studies had small cohorts.

      In present study, the investigators compared IGF-1 to traditional serum biomarkers in terms
      of diagnosing nutritional risk and malnutrition, as well as in monitoring the efficiency of
      nutrition support in CIF patients.

      the investigators conducted a retrospective study of patients treated at a single clinical
      nutrition center of a tertiary referral hospital in China to investigate whether the
      measurement of IGF-1 is useful for monitoring the efficiency of nutritional support and to
      explore the relationship between IGF-1 and lean body mass in CIF patients. The influence of
      IGF-1 was also explored in this study. The data used were accumulated at the center between
      September 2013 and January 2017. All adult CIF patients (age ≥18 years) receiving nutrition
      support were included. The exclusion criteria were hepatic insufficiency (alanine
      transaminase/aspartate transaminase ratio 200% above normal range or bilirubin >3 mg/dL),
      renal insufficiency (serum creatinine [Scr] >1.5 mg/dL), acute or life-threatening diseases
      (e.g., shock, collapse, stroke, coma of unknown etiology, or recent cardiac infarction), and
      pregnant or breast-feeding women. The study was approved by the ethics committee of Jinling
      Hospital, Medical School of Nanjing University.

      Malnutrition was defined as weight loss >10% within 6 months, a body mass index (BMI) <18.5,
      a subjective global assessment (SGA) score of stage C, or albumin level <30 g/L. Serum IGF-1,
      albumin, pre-albumin, transferrin, RBP, creatinine, and hemoglobin were measured weekly in
      patients receiving nutrition support after hospital admission. The resting energy
      expenditure, predicted weekly by indirect calorimetry (Quark PFT ERGO , COSMED Srl - Italy),
      was used to guide energy delivery. The target dose of protein intake was 1.2 g/kg/day, which
      was adjusted according to the level of serum albumin. Patients were also subjected to strict
      fluid intake management. The nutritional support schemes were recorded daily, and the body
      composition was also measured weekly to estimate nutrition status (Inbody S10, Biospace).
observational model: Cohort
time perspective: Retrospective
measure: Nutrition indicators
time frame: From date of patients enrollment until the date of patients discharge from hospital, assessed up to 2 months.
description: Insulin-like growth factor-1/Hemoglobin/albumin/prealbumin/transferrin/retinol binding protein/serum creatinine/cholesterol
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
citation: 1. Bielawska B, Allard JP. Nutrients 2017, 9(5). 2. Pironi L, Arends J, Bozzetti F, Cuerda C, Gillanders L, Jeppesen PB, Joly F, Kelly D, Lal S, Staun M et al. Clinical nutrition 2016, 35(2):247-307. 3. Pironi L. Best Pract Res Clin Gastroenterol 2016, 30(2):173-185. 4. Feinberg J, Nielsen EE, Korang SK, Halberg Engell K, Nielsen MS, Zhang K, Didriksen M, Lund L, Lindahl N, Hallum S et al. The Cochrane database of systematic reviews 2017, 5:Cd011598. 5. Taylor BE, McClave SA, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA et al. Crit Care Med 2016, 44(2):390-438. 6. McClave SA, DiBaise JK, Mullin GE, Martindale RG. Am J Gastroenterol 2016, 111(3):315-334.
responsible party type: Sponsor-Investigator
investigator affiliation: Jinling Hospital, China
investigator full name: Wang Xinying
investigator title: Director of the clinical nutrition center
sharing ipd: No